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| Name | Class |
|---|---|
| Med-El Corporation | INDUSTRY |
The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life.
This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition.
Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable.
It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the acoustic signal via electrical pulses within the cochlea, which is interpreted by the brain as sound.
Presumably, cochlear implantation may provide the SSD population improvements in speech perception in the affected ear, which cannot benefit from appropriately fit hearing aids. Cochlear implantation may provide a benefit over current treatment options in the SSD population, as it stimulates the auditory pathway on the affected side, thus allowing for ipsilateral representation of acoustic signals arriving to each ear independently.
The primary goal of this project is to determine whether subjects with SSD experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition. Secondary aims include: 1) a comparison of speech perception, localization, and quality of life outcomes in the study population to a SSD control group with long-term listening experience with a current treatment option (i.e. bone-conduction device), and 2) a within-subject comparison of speech perception and localization abilities with cochlear implantation versus the bone-conduction test device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear Implant | Experimental | Cochlear implantation of the affected ear |
|
| Control Group | Other | A control group without the study intervention (cochlear implantation) will complete the test battery. |
|
| Cochlear Implant: Asymmetric hearing loss | Experimental | Cochlear implantation of the poorer hearing ear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implant | Device | cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Word Recognition in Quiet Over Time | Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time | Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated. |
| Measure | Description | Time Frame |
|---|---|---|
| Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid) | Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores <20%). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period | Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information. |
Inclusion Criteria (SSD):
Exclusion Criteria (SSD):
Inclusion Criteria (asymmetric hearing loss):
a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list).
b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list).
iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years [Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. [At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities
Exclusion Criteria (Asymmetric hearing loss):
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Dillon, AuD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21068690 | Background | Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271. | |
| 22935813 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear Implant: Unilateral Hearing Loss Group | Cochlear implantation of the affected ear Cochlear Implant: cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss |
| FG001 | Control Group | A control group without the study intervention (cochlear implantation) will complete the test battery. Control Group: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD. |
| FG002 | Cochlear Implant: Asymmetric Hearing Loss Group | Cochlear implantation of the poorer hearing ear Cochlear Implant: cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear Implant: Unilateral Hearing Loss/Single-sided Deafness Group | Cochlear implantation of the affected ear Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (years) at the time of cochlear implantation for treatment groups (unilateral hearing loss/single-sided deafness and asymmetric hearing loss). Age (years) at the time of testing for the control group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Word Recognition in Quiet Over Time | Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use. | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
|
12 months post-activation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss Group | Cochlear implantation of the affected ear Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vertigo / dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
Unable to reach maximum enrollment in the control group (bone conduction device users).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret Dillon | University of North Carolina at Chapel Hill | 9199665251 | mdillon@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2015 | Feb 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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|
| Control Group | Other | Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD. |
|
|
| Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Localization Results (Measured in Variable Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Localization Results (Measured in Constant Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Localization Results (Measured in Adjusted Constant Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time | Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time | Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR). | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR). | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR). | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| preoperative interval and 12 month post-activation interval |
| Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device) | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. | preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months) |
| Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
| Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. | preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months) |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | preoperative interval and 12 month post-activation interval |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | preoperative interval and 12 month post-activation interval |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | preoperative interval and 12 month post-activation interval |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | preoperative interval and 12 month post-activation interval |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | preoperative interval and 12 month post-activation interval |
| Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | preoperative interval and 12 month post-activation interval |
| Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR) | The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off. | Assessment completed after 12 months of implantable bone-conduction listening experience |
| Speech Recognition in Noise for a Control Group: BKB-SIN Test | The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off. | Assessment completed after 12 months of implantable bone-conduction listening experience |
| Localization for a Control Group | Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off. | Assessment completed after 12 months of implantable bone-conduction listening experience |
| Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ) | Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. | Assessment completed after 12 months of implantable bone-conduction listening experience |
| Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB) | Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. | Assessment completed after 12 months of implantable bone-conduction listening experience |
| post-activation period (1, 3, 6, and 12 months post-activation) |
| Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d. |
| 24232066 | Background | Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102. |
| 19005250 | Background | Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13. |
| 28375876 | Derived | Dillon MT, Buss E, Anderson ML, King ER, Deres EJ, Buchman CA, Brown KD, Pillsbury HC. Cochlear Implantation in Cases of Unilateral Hearing Loss: Initial Localization Abilities. Ear Hear. 2017 Sep/Oct;38(5):611-619. doi: 10.1097/AUD.0000000000000430. |
A control group without the study intervention (cochlear implantation) will complete the test battery. Control Group: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD. |
| BG002 | Cochlear Implant: Asymmetric Hearing Loss Group | Cochlear implantation of the poorer hearing ear Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Duration of Hearing Loss | Mean | Standard Deviation | years |
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| OG001 | Cochlear Implant: Asymmetric Hearing Loss Group | Cochlear implantation of the poorer hearing ear Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss |
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| Primary | Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | degrees | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time | Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated. | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Localization Results (Measured in Variable Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | degrees | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Localization Results (Measured in Constant Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | degrees | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Localization Results (Measured in Adjusted Constant Error) Over Time | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. | Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | degrees | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time | Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time | Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated. | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated. | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percentage of words correctly repeated | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR). | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | signal-to-noise ratio | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR). | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | signal-to-noise ratio | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Primary | Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) | Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR). | Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | signal-to-noise ratio | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Secondary | Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid) | Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores <20%). | One asymmetric hearing loss participant withdrew prior to the 12-month interval. | Posted | Mean | Standard Deviation | percentage of words correct | preoperative interval and 12 month post-activation interval |
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| Secondary | Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device) | Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. | Three participants in the asymmetric group did not complete testing at the 9-month interval. One participant did not complete testing with the CI on at the 12-month interval. Three participants did not complete testing in the with the bone conduction device at the 12-month interval. | Posted | Mean | Standard Deviation | degrees | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Secondary | Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months) |
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| Secondary | Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation) |
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| Secondary | Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) | Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. | Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval. | Posted | Mean | Standard Deviation | score on a scale | preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months) |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percent correct | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percent correct | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear) | Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio. | Posted | Mean | Standard Deviation | percent correct | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | One asymmetric hearing loss participant withdrew prior to the 12-month interval. | Posted | Mean | Standard Deviation | signal-to-noise ratio | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | One asymmetric hearing loss participant withdrew prior to the 12-month interval. | Posted | Mean | Standard Deviation | signal-to-noise ratio | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear) | Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). | One asymmetric hearing loss participant withdrew prior to the 12-month interval. | Posted | Mean | Standard Deviation | signal-to-noise ratio | preoperative interval and 12 month post-activation interval |
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| Secondary | Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR) | The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off. | Performance on measures of speech perception | Posted | Median | Full Range | percentage of words correctly repeated | Assessment completed after 12 months of implantable bone-conduction listening experience |
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| Secondary | Speech Recognition in Noise for a Control Group: BKB-SIN Test | The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off. | Posted | Median | Full Range | signal-to-noise ratio | Assessment completed after 12 months of implantable bone-conduction listening experience |
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| Secondary | Localization for a Control Group | Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off. | Posted | Median | Full Range | degrees | Assessment completed after 12 months of implantable bone-conduction listening experience |
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| Secondary | Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ) | Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. | Posted | Median | Full Range | score on a scale | Assessment completed after 12 months of implantable bone-conduction listening experience |
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| Secondary | Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB) | Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. | Posted | Median | Full Range | score on a scale | Assessment completed after 12 months of implantable bone-conduction listening experience |
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| Other Pre-specified | Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period | Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information. | 19 of the 20 participants in the single-sided deafness/unilateral hearing loss group elected to complete the pitch matching task on the five most apical electrodes. One participant missed the 1-month and 3-month intervals. Another participant missed the 6-month interval. | Posted | Mean | Standard Deviation | normalized score | post-activation period (1, 3, 6, and 12 months post-activation) |
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| Post-Hoc | Unaided Hearing in the Implanted Ear Over the Study Period. | The unaided hearing thresholds were measured preoperatively and post-operatively/post-activation. Twenty-five participants with SSD or AHL had an unaided threshold at 125 Hz of 80 dB HL or better. Their unaided thresholds were reviewed with respect to hearing preservation. The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array. | Participants in the SSD/UHL and AHL groups that presented with an unaided threshold at 125 Hz of 80 dB HL or better (n=25). A value of 100 dB HL was entered for cases of no response. Nine participants had a threshold of 95 dB HL or better at initial activation and were reviewed over the post-activation period. Two participants did not complete the 9-month and one participant did not complete the 12-month. | Posted | Mean | Standard Deviation | decibel hearing level | pre-operative, initial activation, and post-activation intervals (1, 3, 6, 9, and 12-months). |
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| Post-Hoc | Localization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error | Subjects were asked to identify the noise source from an 11-speaker array. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Performance was measured with a bone conduction device preoperatively and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. | Three participants in the asymmetric hearing loss group did not complete the task at the 12-month interval. | Posted | Mean | Standard Deviation | degrees | preoperative and 12-month intervals |
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| Post-Hoc | Speech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences | Speech recognition with a bone-conduction device was compared at the preoperative and 12-month intervals. Performance was evaluated for the AzBio sentences in a 10-talker masker (0 dB SNR) presented with the target and masker from the front, the target from the front and masker to the acoustic hearing, and target from the front and masker towards the affected ear. | Thirteen participants with asymmetric hearing loss completed the task at the preoperative and 12-month intervals at 0 dB SNR. | Posted | Mean | Standard Deviation | percent correct | preoperative and 12-month intervals |
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| Post-Hoc | Pitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategy | 9 participants repeated the pitch perception task at the 12-month interval while listening to the CIS strategy. FS4 & CIS strategies differ in whether or not fine structure cues are provided on the 4 most apical electrodes; there is no difference in the cues provided by electrode 5. An adaptive task compared the pitch of acoustic stimulation presented to the normal hearing ear with the stimulation from the cochlear implant. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / presented frequency information. Results are reported as the averaged normalized score for clicks & tones for each electrode. A value of 1.0 indicates the perceived frequency was the same as the electric frequency information. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information. | One participant did not complete testing for electrode 5 | Posted | Mean | Standard Deviation | normalized score | 12-month interval |
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| Post-Hoc | Localization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error. | Subjects were asked to identify the noise source from an 11-speaker array with a bone-conductive device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared at the preoperative and 12-month post-activation intervals. | One participant in the asymmetric group withdrew before the 12-month interval. Two additional participants in the asymmetric hearing loss group did not complete the procedure with the bone-conduction device at the 12-month interval. | Posted | Mean | Standard Deviation | degrees | preoperative and 12-month post-activation intervals. |
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| Post-Hoc | Speech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences | Speech recognition in noise with the AzBio sentences in 3 masker conditions (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear) at the preoperative and 12-month intervals in the unaided condition and with a bone-conduction device. Percent correct results were converted to rationalized arcsine units (RAUs) which helps to control for floor and ceiling effects in the perception correct data (e.g., <20% correct). | All participants in the UHL/SSD group completed the task at 0 dB SNR. Not all participants in the AHL group completed the task at 0 dB SNR. | Posted | Mean | Standard Deviation | rationalized arcsine units | preoperative interval and 12-month post-activation interval. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Cochlear Implant: Asymmetric Hearing Loss Group | Cochlear implantation of the poorer hearing ear Cochlear Implant: cochlear implantation used a treatment for unilateral hearing loss/single-sided deafness and/or asymmetric hearing loss | 0 | 20 | 0 | 20 | 5 | 20 |
| EG002 | Control Group (Recipients of a Bone-conduction Device) | Recipients of a bone-conduction device (alternative treatment technology) with at least 12 months of device use. | 0 | 3 | 0 | 3 | 0 | 3 |
| light-headedness & nausea | Ear and labyrinth disorders | Non-systematic Assessment |
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| imbalance | Ear and labyrinth disorders | Non-systematic Assessment |
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| nystagmus | Ear and labyrinth disorders | Non-systematic Assessment |
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| drainage | General disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| facial stimulation | General disorders | Non-systematic Assessment |
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| bleeding at surgical site | General disorders | Non-systematic Assessment |
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| short circuit | Product Issues | Non-systematic Assessment |
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Not provided
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| Male |
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| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction. | Mixed Models Analysis | Main effects: interval (p=0.012) and condition (p<0.001). Interaction: interval and condition (p=0.004). | <0.012 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed). | bivariate pearson correlation | =0.033 | bivariate pearson correlation | 0.42 | 2-Sided | Other | correlation |
| Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months). | Mixed Models Analysis | Main effects: group (p<0.001) and interval (p<0.001). Interaction: group and interval (p=0.249). | <0.249 | There were significant main effects of group (p<0.001) and interval (p<0.001). There was a non-significant interaction between group and interval (p=0.249). | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
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Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).
| ANOVA |
| =0.056 |
A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. |
| Superiority |
| Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p<0.001) and subscale (p<0.001). Interaction: interval and subscale (p=0.488). | <0.448 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: subscale (p<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299). | <0.299 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p<0.018). | <0.018 | There were significant main effects of interval (p<0.001) and pragmatic subscale (p<0.001), and their interaction (p<0.018). | Superiority |
| Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542). | <0.767 | Superiority |
| Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p=0.003) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p=0.242). | <0.242 | Superiority |
| Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | 0.370 | Other | Bivariate pearson correlation |
| Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.865 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Other | bivariate pearson correlation |
| Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.005 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | bivariate pearson correlation | 0.60 | 2-Sided | Other | bivariate pearson correlation |
| Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.006 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | bivariate pearson correlation | 0.67 | 2-Sided | Other | bivariate pearson correlation |
| Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error). | bivariate pearson correlation | =0.152 | bivariate pearson correlation | -0.33 | 2-Sided | Other | bivariate pearson correlation |
| Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error). | bivariate pearson correlation | =0.761 | Other | bivariate pearson correlation |
| Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error). | bivariate pearson correlation | =0.315 | Other | bivariate pearson correlation |
| Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error). | bivariate pearson correlation | =0.666 | Other | bivariate pearson correlation |
| Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months). | Mixed Models Analysis | Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p>0.175). | >0.175 | Superiority |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: condition (p<0.001) and interval p=0.107). Interaction of condition and interval (p<0.001). | >0.107 | Significant effect of condition (p<0.001) and the interaction (p<0.001). Non-significant effect of interval (p=0.107). Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | <0.001 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | <0.001 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation. | bivariate pearson correlation | =0.580 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Other | bivariate pearson correlation |
| Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months). | Mixed Models Analysis | Effects: SNR (p=0.026) & masker condition (p<0.001). Interactions: cohort & condition (p<0.001), interval & condition (p=0.015). Others (p>0.140). | <0.743 | A logit transformation was applied to proportion correct data prior to analysis. | Superiority |
| Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance. | bivariate pearson correlation | =0.036 | Percent correct converted to rationalized arcsine units (RAU) prior to analysis. | Other | pearson correlation |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction. | Mixed Models Analysis | Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196). | <0.196 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | 0.056 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | =0.210 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction. | Mixed Models Analysis | Main effects: interval (p=0.109) and condition (p<0.001). Interaction: interval and condition (p=0.052). | <0.109 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction. | Mixed Models Analysis | Main effects: interval (p=0.187) and condition (p<0.001). Interaction: interval and condition (p=0.219). | <0.219 | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
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The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.
| ANOVA |
| =0.264 |
A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. |
| Superiority |
| The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023). | <0.023 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation). | Mixed Models Analysis | Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480). | <0.643 | Superiority |
| Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.947 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Other | bivariate pearson correlation (one-tailed) |
| Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.500 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.023 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | bivariate pearson correlation | -0.51 | 2-Sided | Other | bivariate pearson correlation |
| Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear. | bivariate pearson correlation | =0.033 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | bivariate pearson correlation | -0.55 | 2-Sided | Other | bivariate pearson correlation |
| Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months). | Mixed Models Analysis | Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p>0.287). | >0.208 | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
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| The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers "yes" (4 points), "sometimes" (2 points), or "no" (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months). | ANOVA | =0.538 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months). | Mixed Models Analysis | Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218). | >0.218 | There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218). | Superiority |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118). | <0.317 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | =0.017 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | =0.292 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance. | bivariate pearson correlation | >0.185 | Other | pearson correlation |
| 1 month after surgery, unaided |
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| 1 month after surgery, aided (cochlear implant) |
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| 3 months after surgery, unaided |
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| 3 months after surgery, aided (cochlear implant) |
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| 6 months after surgery, unaided |
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
|
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| Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817). | <0.817 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | =0.008 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU. | ANOVA | =0.009 | Superiority |
| Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed). | bivariate pearson correlation | =0.049 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz. | Other | bivariate correlation |
| Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance. | bivariate pearson correlation | >0.185 | Other | pearson correlation |
| 1 month after surgery, unaided |
|
|
| 1 month after surgery, aided (cochlear implant) |
|
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| 3 months after surgery, unaided |
|
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| 3 months after surgery, aided (cochlear implant) |
|
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| 6 months after surgery, unaided |
|
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| 6 months after surgery, aided (cochlear implant) |
|
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| 9 months after surgery, unaided |
|
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| 9 months after surgery, aided (cochlear implant) |
|
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| 12 months after surgery, unaided |
|
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| 12 months after surgery, aided (cochlear implant) |
|
|
| Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: condition (p<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379). | <0.379 | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | =0.021 | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | <0.001 | Superiority |
| 1 month after surgery, unaided |
|
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| 1 month after surgery, aided (cochlear implant) |
|
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| 3 months after surgery, unaided |
|
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| 3 months after surgery, aided (cochlear implant) |
|
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| 6 months after surgery, unaided |
|
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| 6 months after surgery, aided (cochlear implant) |
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| 9 months after surgery, unaided |
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| 9 months after surgery, aided (cochlear implant) |
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| 12 months after surgery, unaided |
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| 12 months after surgery, aided (cochlear implant) |
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| Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: condition (p<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450). | <0.637 | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | =0.002 | Superiority |
| 1 month after surgery, unaided |
|
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| 1 month after surgery, aided (cochlear implant) |
|
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| 3 months after surgery, unaided |
|
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| 3 months after surgery, aided (cochlear implant) |
|
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| 6 months after surgery, unaided |
|
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| 6 months after surgery, aided (cochlear implant) |
|
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| 9 months after surgery, unaided |
|
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| 9 months after surgery, aided (cochlear implant) |
|
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| 12 months after surgery, unaided |
|
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| 12 months after surgery, aided (cochlear implant) |
|
|
| Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. | Mixed Models Analysis | Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960). | >0.124 | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | =0.025 | Superiority |
| Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). | ANOVA | =0.442 | Superiority |
Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear). |
| t-test, 2 sided |
| <0.001 |
Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. |
| Superiority |
| 1-month, cochlear implant |
|
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| 3-month, cochlear implant |
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| 6-month, cochlear implant |
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| 9-month, cochlear implant |
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| 12-month, cochlear implant |
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| 12-month, bone conduction device |
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| Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test. | t-test, 2 sided | <0.001 | Superiority |
| Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test. | t-test, 2 sided | <0.001 | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
|
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| The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA. | ANOVA | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant. | Mixed Models Analysis | Main effects: interval (p<0.001) and subscales (p<0.001). Interaction: interval and subscales (p<0.001). | <0.001 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant. | Mixed Models Analysis | Main effects: interval (p<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001). | <0.010 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
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| The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers "yes" (4 points), "sometimes" (2 points), or "no" (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant. | ANOVA | =0.003 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| 1 month after surgery |
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| 3 months after surgery |
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| 6 months after surgery |
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| 9 months after surgery |
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| 12 months after surgery |
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Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). |
| ANOVA |
| <0.001 |
A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. |
| Superiority |
| Responses on the SSQ as measured with the subscales (speech, spatial, & qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction. | Mixed Models Analysis | Main effects: interval (p<0.001) and subscale (p<0.001). Interaction: interval and subscale (p=0.001). | <0.001 | There were significant main effects of interval (p<0.001) and subscale (p<0.001) and interaction (p=0.001). A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Responses on the SSQ as measured with the subscales (speech, spatial, & qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction. | Mixed Models Analysis | Main effects: interval (p<0.001) and subscale (p<0.001). Interaction: interval and subscale (p=0.034). | <0.034 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |
| Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p<0.001). | <0.001 | Superiority |
| Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effect: interval (p<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001). | <0.192 | Superiority |
| Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p<0.001). | <0.001 | Superiority |
| Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p=0.479). | <0.479 | Superiority |
| Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effect: interval (p<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090). | <0.804 | Superiority |
| Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time. | Mixed Models Analysis | Main effects: interval (p<0.001) and pragmatic subscale (p<0.001). Interaction: interval and pragmatic subscale (p=0.005). | <0.005 | Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. |
| t-test, 2 sided |
| =0.034 |
| Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. |
| t-test, 2 sided |
| =0.037 |
| Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. |
| t-test, 2 sided |
| =0.001 |
| Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance. |
| t-test, 2 sided |
| =0.004 |
| Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance. |
| t-test, 2 sided |
| =0.727 |
| Superiority |
| 12-month post-activation, cochlear implant |
|
|
Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance. |
| t-test, 2 sided |
| =0.090 |
| Superiority |
| Title | Measurements |
|---|---|
|
| SoNo, device off |
|
| SoNbc, device off |
|
| SoNnh, device off |
|
| Title | Measurements |
|---|---|
|
| SoNo, device off |
|
| SoNbc, device off |
|
| SoNnh, device off |
|
|
| Total score |
|
| Title | Measurements |
|---|---|
|
| effectiveness in background noise |
|
| aversiveness to sounds |
|
|
| 1-month: electrode 2, click |
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| 1-month: electrode 2, tone |
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| 1-month: electrode 3, click |
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| 1-month: electrode 3, tone |
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| 1-month: electrode 4, click |
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| 1-month: electrode 4, tone |
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| 1-month: electrode 5, click |
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| 1-month: electrode 5, tone |
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| 3-month: electrode 1, click |
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| 3-month: electrode 1, tone |
|
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| 3-month: electrode 2, click |
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| 3-month: electrode 2, tone |
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| 3-month: electrode 3, click |
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| 3-month: electrode 3, tone |
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| 3-month: electrode 4, click |
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| 3-month: electrode 4, tone |
|
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| 3-month: electrode 5, click |
|
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| 3-month: electrode 5, tone |
|
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| 6-month: electrode 1, click |
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| 6-month: electrode 1, tone |
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| 6-month: electrode 2, click |
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| 6-month: electrode 2, tone |
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| 6-month: electrode 3, click |
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| 6-month: electrode 3, tone |
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| 6-month: electrode 4, click |
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| 6-month: electrode 4, tone |
|
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| 6-month: electrode 5, click |
|
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| 6-month: electrode 5, tone |
|
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| 12-month: electrode 1, click |
|
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| 12-month: electrode 1, tone |
|
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| 12-month: electrode 2, click |
|
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| 12-month: electrode 2, tone |
|
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| 12-month: electrode 3, click |
|
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| 12-month: electrode 3, tone |
|
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| 12-month: electrode 4, click |
|
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| 12-month: electrode 4, tone |
|
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| 12-month: electrode 5, click |
|
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| 12-month: electrode 5, tone |
|
|
Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone. |
| bivariate pearson correlation |
| >0.164 |
| Other |
| Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear). | bivariate pearson correlation | >0.367 | Other | bivariate pearson correlation |
| Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error). | bivariate pearson correlation | >0.349 | Other | bivariate pearson correlation |
|
| 1-month post-activation |
|
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| 3-month post-activation |
|
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| 6-month post-activation |
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| 9-month post-activation |
|
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| 12-month post-activation |
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|
Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval. The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array. |
| ANOVA |
generalized linear mixed-effects model |
| =0.47 |
| Superiority |
| 12-month |
|
|
| t-test, 2 sided |
| =0.553 |
| Superiority |
| preoperative, speech front and noise to the acoustic ear |
|
|
| preoperative, speech front and noise to the affected ear |
|
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| 12-month, speech front and noise front |
|
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| 12-month, speech front and noise to the acoustic ear |
|
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| 12-month, speech front and noise to the affected ear |
|
|
| A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device. | ANOVA | Main effect: masker condition (p<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055). | <0.577 | Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. | Superiority |
|
| electrode 2, FS4 |
|
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| electrode 2, CIS |
|
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| electrode 3, FS4 |
|
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| electrode 3, CIS |
|
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| electrode 4, FS4 |
|
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| electrode 4, CIS |
|
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| electrode 5, FS4 |
|
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| electrode 5, CIS |
|
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Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode. |
| t-test, 2 sided |
Pitch perception for electrode 1 (p=0.035). All other comparisons were p>0.318. |
| >0.035 |
| Superiority |
| before surgery, bone conduction device |
|
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| 12-month, unaided |
|
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| 12-month, bone conduction device |
|
|
A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization. |
| ANOVA |
Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678). |
| >0.434 |
| Superiority |
| preop, bone-conduction, masker towards better ear |
|
|
| 12-month, unaided, masker towards better ear |
|
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| 12-month, bone-conduction, masker towards better ear |
|
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| preop, unaided, masker from front |
|
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| preop, bone-conduction, masker from front |
|
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| 12-month, unaided, masker from front |
|
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| 12-month, bone-conduction, masker from front |
|
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| preop, unaided, masker towards poorer ear |
|
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| preop, bone-conduction, masker towards poorer ear |
|
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| 12-month, unaided, masker towards poorerear |
|
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| 12-month, bone-conduction, masker from towards poorer ear |
|
|
| A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise. | ANOVA | Effects: interval (p=0.012) and masker (p<0.001). Interactions: interval&masker (p=0.020) & condition, interval, &masker (p=0.035). Others: (p>0.131). | <0.977 | A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity. | Superiority |