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Cochlear implant tuning gets personal: could Anatomy-Based settings boost hearing?

NCT ID NCT06734039

Symptom relief Sponsor: Med-El Corporation Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adjusting the frequency settings of a cochlear implant based on a person's ear anatomy can improve hearing and quality of life. Fifty new cochlear implant users with some hearing in their other ear will try two different settings and complete hearing tests and questionnaires. The goal is to see if personalized programming helps them hear better in noisy environments.

What this could mean

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

Active substance
Cochlear implant audio processor with anatomy-based frequency settings
What this could lead to
If successful, this could lead to better hearing in noise and improved quality of life for cochlear implant users with residual hearing.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to all users. The benefit of personalized frequency settings may be minimal for some individuals.

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

Nov 2025

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.

* At least 18 years of age * Is a cochlear implant candidate as deemed by the participating center * Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear. * For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment * Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear. * Programmed with electric-only stimulation in the implanted ear * The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz * Post-operative CT scan allows for completion of OTOPLAN analysis * ABF settings possible at defaults in clinical programming software * Minimum of 10 active electrodes at activation * Programmed using a Fine Structure coding strategy * English is the primary language * Willing and able to comply with all scheduled procedures as defined in the protocol Exclusion Criteria: * Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study * Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use * Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval

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Conditions

The condition(s) this trial relates to.

deafness, unilateral Hearing Loss, Sensorineural Hearing Loss, Unilateral sensorineural hearing loss disorder

As listed by the trial registrant

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

Asymmetric hearing loss Cochlear implants Hearing loss, sensorineural Hearing loss, unilateral Single-sided deafness (SSD)

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • MED-EL Corporation

    Durham, North Carolina, 27516, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

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