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Could cochlear implants help more people hear? new study expands eligibility.

NCT ID NCT06293482

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether cochlear implants are safe and effective for adults with severe hearing loss in both ears who currently don't meet standard implant criteria. Fifty participants will receive an implant and be followed for 6 months to measure improvements in word recognition and sentence understanding in noise. The goal is to see if expanding who can get these implants can help more people hear better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 implant during the clinical investigation. * Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation. * Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator. * Additional disabilities that may affect the participant's participation of safety during the clinical investigation. * Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Employees of Cochlear. * Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.

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Conditions

The condition(s) this trial relates to.

hearing loss disorder Hearing Loss, Bilateral Hearing Loss, Sensorineural sensorineural hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Centre for Neurosciences

    Tucson, Arizona, 85718, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Midwest Ear Institute

    Kansas City, Missouri, 64111, United States

  • New York University

    New York, New York, 10016, United States

  • Pacific Neuroscience Institute

    Santa Monica, California, 90404, United States

  • University of Miami

    Coral Gables, Florida, 33146, United States

  • University of Pennsylvania Hospitals

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.