CompletedNot Applicable

Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

United States40 participantsStarted 2017-07-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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): * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet

Timeframe: Pre-implant and 6 months post-implant

Change in Poor Ear Alone Soundfield Thresholds

Timeframe: Pre-implant and 6 months post-implant

Trial details

NCT IDNCT03052920

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-17

Results submitted2021-09-01

View on ClinicalTrials.gov More Hearing Loss trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.