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Custom cochlear implant tuning based on ear shape may boost hearing

NCT ID NCT05451628

Disease control Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether programming a cochlear implant based on each person's unique inner ear structure improves hearing compared to the standard one-size-fits-all approach. Adults with severe to profound hearing loss who already have a MED-EL cochlear implant will receive both types of programming and have their speech recognition tested. The goal is to see if matching the implant's frequency settings to the natural layout of the cochlea leads to better sound perception.

What this could mean

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

Active substance
Anatomy-based cochlear implant fitting (device programming)
What this could lead to
If successful, this approach could make cochlear implants work better for each person, potentially improving speech understanding in quiet and noisy settings.
What could go wrong
This is a small, early-stage study with 40 participants, so results may not apply to everyone. The new fitting method may not provide a meaningful benefit over standard care.

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

Mar 2022

Expected to finish

Jan 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 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: * Age ≥ 18 years * Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * Post-operative Computed Tomography (CT) scan of the CI electrode available * Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available * Subject implanted with MED-EL cochlear implant(s) * Subjects received a Flex28, FlexSoft or Standard electrode * Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side * Audio processor not yet activated on the newly implanted side * The most apical active electrode contact has to be inserted at least 450° * Minimum of 10 active channels can be activated * Fluent in the language of the test centre * Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure Exclusion Criteria: * Lack of compliance with any inclusion criteria * Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor) * Implanted with C40+, C40X and C40C * Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array * Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study

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Conditions

The condition(s) this trial relates to.

Hearing Loss, Sensorineural sensorineural hearing loss disorder X-linked mixed hearing loss with perilymphatic gusher

As listed by the trial registrant

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

Cochlear implants Sensorineural hearing loss

How to take part

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

  1. The places running it

    2 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

  • Antwerp University Hopsital

    RECRUITING

    Antwerp, 2650, Belgium

  • University Hospital Brussels

    RECRUITING

    Brussels, Brussels Capital, 1090, Belgium

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