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| Name | Class |
|---|---|
| Med-El Corporation | INDUSTRY |
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This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child.
Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development.
The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear Implant | Experimental | Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Device | Implantation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval. | up to 24 months post-activation |
| Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. | 6 months post-activation |
| Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. | 12 months post-activation |
| Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. |
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i) Inclusion Criteria
Unilateral moderate-to-profound sensorineural hearing loss.
Between 3 years, 6 mos and 6 years, 6 mos of age at implantation.
Anatomically normal cochlear nerve
Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including:
No evidence of progressive hearing loss.
Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear desired sensation level (DSL) method.
Aided word recognition in the ear to be implanted of 30% or less as measured with Consonant Nucleus Consonant (CNC) words (50-word list)
Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing.
Willing to obtain recommended meningitis vaccinations per CDC recommendations.
(9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised.
(10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities.
ii) Exclusion Criteria
English is not primary language of the home
Conductive hearing loss in either ear
Compromised auditory nerve
Ossification of the cochlea
Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment)
Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
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| Name | Affiliation | Role |
|---|---|---|
| Kevin D Brown, MD, PhD | 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 | 27599-7600 | 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 | Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Ethnicity data were not collected,
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear Implant | Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval. | One participant was lost to follow-up after Month 12 | Posted | Mean | Standard Deviation | percentage of words correct | up to 24 months post-activation |
|
From the time of surgery through the Month 24 visit, a total of up to 25 months
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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 | Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial stimulation | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Park, AuD, CCC-A | University of North Carolina at Chapel Hill | 984-215-2871 | lisa_park@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 | Aug 13, 2018 | Jun 14, 2021 | 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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Not provided
| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| 24 months post-activation |
| Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | 3 months post-activation |
| Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | 9 months post-activation |
| Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | 18 months post-activation |
| Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | 24 months post-activation |
| Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals. | Pre-operatively through 24 months post-activation |
| Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval. | Pre-operatively through 24 months post-activation |
| Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue. | Pre-operatively through 24 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. |
| 3949097 | Background | Bess FH, Tharpe AM, Gibler AM. Auditory performance of children with unilateral sensorineural hearing loss. Ear Hear. 1986 Feb;7(1):20-6. doi: 10.1097/00003446-198602000-00005. |
| 25999052 | Background | Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19. |
| 21389710 | Background | Kompis M, Pfiffner F, Krebs M, Caversaccio MD. Factors influencing the decision for Baha in unilateral deafness: the Bern benefit in single-sided deafness questionnaire. Adv Otorhinolaryngol. 2011;71:103-111. doi: 10.1159/000323591. Epub 2011 Mar 8. |
| 17634123 | Background | Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43. |
| 14485785 | Background | PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available. |
| 23394704 | Background | Galvin KL, Noble W. Adaptation of the speech, spatial, and qualities of hearing scale for use with children, parents, and teachers. Cochlear Implants Int. 2013 Jun;14(3):135-41. doi: 10.1179/1754762812Y.0000000014. |
| 36879386 | Derived | Park LR, Dillon MT, Buss E, Brown KD. Two-Year Outcomes of Cochlear Implant Use for Children With Unilateral Hearing Loss: Benefits and Comparison to Children With Normal Hearing. Ear Hear. 2023 Sep-Oct 01;44(5):955-968. doi: 10.1097/AUD.0000000000001353. Epub 2023 Mar 7. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ear Affected | Count of Participants | Participants |
|
| Etiology of Hearing Loss | Count of Participants | Participants |
|
| Suspected Length of Deafness | Mean | Standard Deviation | years |
|
|
|
|
| Primary | Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. | Posted | Mean | 95% Confidence Interval | signal-to-noise ratio | 6 months post-activation |
|
|
|
| Primary | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. | Posted | Mean | 95% Confidence Interval | signal-to-noise ratio | 12 months post-activation |
|
|
|
|
| Primary | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. | One participant was lost to follow-up after Month 12 | Posted | Mean | 95% Confidence Interval | signal-to-noise ratio | 24 months post-activation |
|
|
|
|
| Primary | Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | Posted | Median | 95% Confidence Interval | degrees | 3 months post-activation |
|
|
|
| Primary | Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | Posted | Median | 95% Confidence Interval | degrees | 9 months post-activation |
|
|
|
| Primary | Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | One participant was lost to follow-up after Month 12 | Posted | Median | 95% Confidence Interval | degrees | 18 months post-activation |
|
|
|
| Primary | Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. | One participant was lost to follow-up after Month 12 | Posted | Median | 95% Confidence Interval | degrees | 24 months post-activation |
|
|
|
|
| Primary | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals. | One participant was lost to follow-up after Month 12 | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-operatively through 24 months post-activation |
|
|
|
|
| Primary | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval. | One participant was lost to follow-up after Month 12 | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-operatively through 24 months post-activation |
|
|
|
|
| Primary | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue. | One participant was lost to follow-up after Month 12 | Posted | Mean | 95% Confidence Interval | score on a scale | Pre-operatively through 24 months post-activation |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment |
|
| Sensory processing disorder | General disorders | Non-systematic Assessment |
|
| Hearing loss progression in contralateral ear | Ear and labyrinth disorders | Non-systematic Assessment |
|
Not provided
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 |
|
|
|
|
| Adjusted constant error from device off to device on |
|
|
| Adjusted constant error from device off to device on |
|
|
| Adjusted constant error from device off to device on |
|
|
| Adjusted constant error from device off to device on |
|
|
| Speech: 3-month to 9-month post-activation interval |
|
|
| Speech: 3-month to 12-month post-activation interval |
|
|
| Speech: 3-month to 18-month post-activation interval |
|
|
| Speech: 3-month to 24-month post-activation interval |
|
|
| Spatial: pre-operative to 3-month post-activation interval |
|
|
| Spatial: 3-month to 6-month post-activation interval |
|
|
| Spatial: 3-month to 9-month post-activation interval |
|
|
| Spatial: 3-month to 12-month post-activation interval |
|
|
| Spatial: 3-month to 18-month post-activation interval |
|
|
| Spatial: 3-month to 24-month post-activation interval |
|
|
| Qualities: pre-operative to 3-month post-activation interval |
|
|
| Qualities: 3-month to 6-month post-activation interval |
|
|
| Qualities: 3-month to 9-month post-activation interval |
|
|
| Qualities: 3-month to 12-month post-activation interval |
|
|
| Qualities: 3-month to 18-month post-activation interval |
|
|
| Qualities: 3-month to 24-month post-activation interval |
|
|
| Mixed Models Analysis |
| 0.001 |
The a priori threshold for statistical significance was p < 0.05. |
| Superiority |
| Comparison of scores across time to investigate change in scores over time: Qualities subtest. | Mixed Models Analysis | < 0.001 | The a priori threshold for statistical significance was p < 0.05. | Superiority |
|
| 3-month to the 9-month post-activation interval |
|
|
| 3-month to the 12-month post-activation interval |
|
|
| 3-month to the 18-month post-activation interval |
|
|
| 3-month to the 24-month post-activation interval |
|
|
|
| General Fatigue: 3-month to 9-month post-activation |
|
|
| General Fatigue: 3-month to 12-month post-activation |
|
|
| General Fatigue: 3-month to 18-month post-activation |
|
|
| General Fatigue: 3-month to 24-month post-activation |
|
|
| Sleep Fatigue: Pre-operative to 3-month post-activation |
|
|
| Sleep Fatigue: 3-month to 6-month post-activation |
|
|
| Sleep Fatigue: 3-month to 9-month post-activation |
|
|
| Sleep Fatigue: 3-month to 12-month post-activation |
|
|
| Sleep Fatigue: 3-month to 18-month post-activation |
|
|
| Sleep Fatigue: 3-month to 24-month post-activation |
|
|
| Cognitive Fatigue: Pre-operative to 3-month post-activation |
|
|
| Cognitive Fatigue: 3-month to 6-month post-activation |
|
|
| Cognitive Fatigue: 3-month to 9-month post-activation |
|
|
| Cognitive Fatigue: 3-month to 12-month post-activation |
|
|
| Cognitive Fatigue: 3-month to 18-month post-activation |
|
|
| Cognitive Fatigue: 3-month to 24-month post-activation |
|
|
| Mixed Models Analysis |
| 0.109 |
The a priori threshold for statistical significance was p < 0.05. |
| Superiority |
| Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest | Mixed Models Analysis | 0.1733 | The a priori threshold for statistical significance was p < 0.05. | Superiority |