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| Name | Class |
|---|---|
| Midwest Ear Institute | OTHER |
| House Clinic, Inc. | INDUSTRY |
| NYU Langone Health | OTHER |
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This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.
The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites.
Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life).
Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows:
Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study.
Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear Implantation | Experimental | Cochlear implantation of the poor hearing ear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Device | Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.) | Pre-implant and 6 months post-implant |
| Change in Poor Ear Alone Soundfield Thresholds | Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.) | Pre-implant and 6 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sound Localization | Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.) | Pre-implant and 6 months post-implant |
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Inclusion Criteria:
18 years of age or older
English as the native language
Have a desire for functional binaural hearing
Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
Willingness to comply with all study requirements
Ability to provide informed consent
Poor ear (ear to be implanted):
Better ear:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill B Firszt, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| House Clinic | Los Angeles | California | 90057 | United States | ||
| Saint Luke's Midwest Ear Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34126876 | Derived | Sampathkumar R, Kaehne A, Kumar N, Kameswaran M, Irving R. Systematic review of cochlear implantation in adults with asymmetrical hearing loss. Cochlear Implants Int. 2021 Nov;22(6):311-329. doi: 10.1080/14670100.2021.1936363. Epub 2021 Jun 14. |
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Recruitment occurred from Summer 2017 through 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear Implantation | Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear Implantation | Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.) | 36 participants had both pre-implant and 6-month post-implant CNC scores for the poor ear alone. | Posted | Mean | Standard Error | percentage of words correct | Pre-implant and 6 months post-implant |
|
Approximately 15 months, from enrollment until 12-month evaluation.
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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 Implantation | Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | onset or worsening |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill B Firszt, PI | Washington University in St. Luis | 314-362-4760 | FirsztJ@wustl.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 | Apr 27, 2018 | Apr 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.) | Pre-implant and 6 months post-implant |
| Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.) | Pre-implant and 6 months post-implant |
| Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) | Pre-implant and 6 months post-implant |
| Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.) | Pre-implant and 6 months post-implant |
| Change in Hearing Handicap Inventory (HHIE) | Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.) | Pre-implant and 6 months post-implant |
| Change in Health Utility Index (HUI3) Ratings | Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.) | Pre-implant and 6 months post-implant |
| Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) | Pre-implant and 6 months post-implant |
| Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) | Pre-implant and 12 months post-implant |
| Change in Satisfaction With Amplification in Daily Use (SADL) | Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.) | Pre-implant and 6 months post-implant |
| Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.) | Pre-implant and 6 months post-implant |
| Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.) | Pre-implant and 6 months post-implant |
| Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) | Pre-implant and 6 months post-implant |
| Kansas City |
| Missouri |
| 64111 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Length of Deafness - Poor Ear | Mean | Standard Deviation | years |
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| Primary | Change in Poor Ear Alone Soundfield Thresholds | Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.) | 36 participants had both pre-implant and 6-month post-implant Soundfield thresholds for the poor ear alone. | Posted | Mean | Standard Error | Decibels | Pre-implant and 6 months post-implant |
|
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|
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| Secondary | Change in Sound Localization | Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.) | 36 participants had both pre-implant and 6-month localization scores in the bilateral/bimodal condition | Posted | Mean | Standard Error | degrees RMS error | Pre-implant and 6 months post-implant |
|
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|
|
| Secondary | Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.) | Both pre-implant and 6-month post-implant data were available for 36 participants. | Posted | Mean | Standard Error | percentage of words correct | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.) | 36 participants had both pre-implant and 6-mongh post-implant AzBio scores in noise. | Posted | Mean | Standard Error | percentage of words correct | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) | 36 participants had BKB-SIN scores for noise to the better ear at both the pre-implant and 6-month test intervals | Posted | Mean | Standard Error | dB Signal-to-Noise Ratio | Pre-implant and 6 months post-implant |
|
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|
|
| Secondary | Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.) | 36 participants had poor ear alone AzBio sentence scores at both the pre-implant and 6-month test intervals. | Posted | Mean | Standard Error | percentage of words correct | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in Hearing Handicap Inventory (HHIE) | Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.) | 39 participants had completed the HHIE at both the pre-implant and 6-month post-implant test intervals. | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in Health Utility Index (HUI3) Ratings | Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.) | 39 participants completed the HUI3 at both the pre-implant and 6-month post-implant test intervals. | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) | 39 participants had SSQ ratings at both the pre-implant and 6-month test intervals. | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
|
|
|
|
| Secondary | Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) | 39 participants had SSQ ratings for both the pre-implant and 12-month post-implant test intervals. (These were not the same 39 who had SSQ ratings at both the 6-month and pre-implant test intervals.) | Posted | Mean | Standard Error | score on a scale | Pre-implant and 12 months post-implant |
|
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| Secondary | Change in Satisfaction With Amplification in Daily Use (SADL) | Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.) | 39 participants completed the HA version of the SADL pre-implant and also the bimodal version at 6 months post-implant (a modification of the original SADL). | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
|
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| Secondary | Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.) | 26 participants had a spouse or significant other who completed the CPHI at both the pre-implant and 6-month post-implant test intervals. | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
|
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| Secondary | Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.) | 26 participants had a spouse or significant other who completed the HII-SOP at both the pre-implant and 6 month post-implant test intervals. | Posted | Mean | Standard Error | score on a scale | Pre-implant and 6 months post-implant |
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| Secondary | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) | 36 participants had BKB-SIN scores for noise to the poor ear at both the pre-implant and 6-month test intervals | Posted | Mean | Standard Error | dB Signal-to-Noise Ratio | Pre-implant and 6 months post-implant |
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|
| 0 |
| 40 |
| 8 |
| 40 |
| 11 |
| 40 |
| Infection | Infections and infestations | Systematic Assessment | at surgical site |
|
| Coronary angioplasty and stint | Vascular disorders | Non-systematic Assessment |
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| Gall bladder removal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment | Result of anesthesia |
|
| Kidney stone removal | Renal and urinary disorders | Non-systematic Assessment |
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| Tear of medial meniscus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Heart bypass surgery | Cardiac disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment | onset or worsening |
|
| Swelling | Ear and labyrinth disorders | Systematic Assessment | Swelling over the cochlear implant receiver/stimulator |
|
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| 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 |
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