Hearing LossNCT03052920
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
A study testing Cochlear implant in people with Hearing Loss, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jul 2017to 10 Mar 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Poor ear (ear to be implanted):
- Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
- Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
- Duration of SPHL ≥ 6 months
- Onset of hearing loss ≥ 6 years of age
- Better ear:
- PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
- Currently using a HA
- Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%
- Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies
Who cannot join
- Medical condition that contraindicates surgery
- Actively using an implantable device in the ear to be implanted
- Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
- Hearing loss of neural or central origin
- Unrealistic expectations related to the benefits and limitations of cochlear implantation
- Unwillingness or inability to comply with all investigational requirements
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Saint Luke's Midwest Ear Institute
Kansas City, Missouri, 64111
House Clinic
Los Angeles, California, 90057
New York University School of Medicine
New York, New York, 10016
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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:
- Hearing aid (HA) in the better ear alone
- HA in the poor ear alone
- Bilateral HAs
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:
- HA in the better ear alone
- CI in the poor ear alone
- HA and CI together
- Conditions
- Hearing Loss
- Being tested
- Cochlear implant
- Keywords
- cochlear implant, asymmetric hearing loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
Also called Cochlear America, Advanced Bionics, MED-EL
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.
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implantation | Experimental | Cochlear implantation of the poor hearing ear Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: Pre-implant and 6 months post-implant
Secondary outcomes (13)
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.)
Measured: Pre-implant and 6 months post-implant
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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: Pre-implant and 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start28 Jul 2017
- Primary completion17 Nov 2020
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Ear Institute, House Clinic, Inc., NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Jill B Firszt, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052920
- Sponsor's protocol ID
- 201612147
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2017
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34126876