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New device aims to save natural hearing during cochlear implant surgery

NCT ID NCT04707885

Knowledge-focused Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a special monitoring tool called electrocochleography can help surgeons preserve a patient's remaining natural hearing while placing a cochlear implant. About 40 adults with severe hearing loss in both ears will be randomly assigned to receive the monitoring or standard surgery. Researchers will measure hearing levels over two years to see if the device makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Electrocochleography monitoring device
What this could lead to
If successful, this could help surgeons preserve more natural hearing during cochlear implant surgery, improving outcomes for patients.
What could go wrong
This is a small, early-stage study focused on measuring hearing preservation, not a treatment. The device may not provide a clear advantage over standard surgery.

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 40 people

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

Started

Nov 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 79 years

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: 1. Provision of signed and dated informed consent form. 2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset. 3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets. 4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of: 1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct) 2. Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct) 5. Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted. 6. Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted. 7. Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear. 8. Proficient in English. 9. Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG. 1. Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624 2. Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala 10. Stated willingness and ability to complete testing and all associated study visits. Exclusion Criteria: 1. Previous cochlear implantation. 2. Prelingual onset of hearing loss. 3. Abnormal inner ear anatomy on CT imaging. 4. Auditory neuropathy spectrum disorder. 5. Retrocochlear pathology such as a vestibular schwannoma or stroke. 6. Unwillingness or inability to comply with all investigational requirements including the randomization process. 7. Additional medical, or social barriers that would prevent completion of all study requirements. 8. Medical condition contraindicated for surgery. 9. Device selection of Med El CI (per the patient's selection).

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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.

Hearing loss Hearing loss, bilateral Hearing loss, sensorineural

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Ohio State University Eye and Ear Institute

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of North Carolina, Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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