Active — Not RecruitingNot Applicable

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

United States50 participantsStarted 2024-09-17

Plain-language summary

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

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: * Individuals 18 or older at the time of consent * Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, \& 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as \<50% correct on a word recognition test * Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, \& 4000 Hz of \>30 dB HL * Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. * Willing and able to provide written informed consent. Exclusion Criteria: * Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound \[≥ 90 dB HL\] hearing loss in the mid to high speech frequencies) * Absence of cochlea development or a cochlear nerve * Presence of active middle ear infection in the ear to be implanted * Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted * Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation. * Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear…

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

Number of device and procedure-related adverse events and serious adverse events

Timeframe: 6-months post-activation

Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted

Timeframe: Pre-operative baseline, 6 months post-activation

Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition

Timeframe: Pre-operative baseline, 6 months post-activation

Trial details

NCT IDNCT06293482

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-16

View on ClinicalTrials.gov More Hearing Loss, Sensorineural trials

Plain-language summary

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.

What they're measuring

Number of device and procedure-related adverse events and serious adverse events

Timeframe: 6-months post-activation

Timeframe: Pre-operative baseline, 6 months post-activation

Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition

Timeframe: Pre-operative baseline, 6 months post-activation