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Can smart cochlear implants help kids hear better in noise?

NCT ID NCT06400992

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether automatic sound processing in cochlear implants helps children with hearing loss understand speech in noisy environments. Twenty children aged 6 to 16 who use cochlear implants will compare three different sound settings. The goal is to see which setting gives the best hearing in noise.

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 processor with AutoSense Sky OS technology
What this could lead to
If it works, this could point toward better hearing in noise for children with cochlear implants.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply to all children. The improvement may be small or not noticeable.

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 20 people

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

Started

Dec 2024

Expected to finish

Jun 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

6 to 16 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: * Be between 6 and 16 years of age at the time of inclusion * Use spoken French as their primary mode of communication * Ability to perform the Simplified French Matrix test in Noise * Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid * Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors * Obtain signed consent from legal guardian(s) * Be enrolled in a health insurance plan or eligible for coverage Exclusion Criteria: * Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup * Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion * Family does not understand French

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") at the Necker-Enfants Malades hospital (AP-HP).

    RECRUITING

    Paris, 75015, France

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