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Could a cochlear implant help kids who are deaf in one ear?

NCT ID NCT06930170

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study looks at whether a cochlear implant can help children aged 4 to 6 who have severe hearing loss in one ear but normal hearing in the other. The implant is compared to a special hearing aid (CROS or BiCROS). The main goal is to see if the implant improves the child's ability to understand speech in noisy settings after 18 months. Thirty-six children will take part, and the results could guide better treatment for this condition.

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 device
What this could lead to
If successful, this could show that cochlear implants help children with hearing loss in one ear hear better in noisy places, improving daily life.
What could go wrong
This is a small, early-stage study with only 36 children, so results may not apply to everyone. Surgery risks include infection or device failure.

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 36 people

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

Started

Mar 2026

Expected to finish

Apr 2029

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

4 to 6 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: * Child aged 4 to 6 years at the time of inclusion * Using spoken French as the primary mode of communication * Diagnosed with unilateral or asymmetric hearing loss : Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal hearing in the better ear (thresholds ≤ 25 dB between 500-4000 Hz, established by audiometry or ASSR). Asymmetric is defined by severe to profound hearing loss in the weaker ear (thresholds \> 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and mild hearing loss in the better ear (thresholds between 30-40 dB at ≤ 4 frequencies, established by audiometry or ASSR). * Written informed consent from both legal guardians (or the sole guardian, if applicable) * Affiliated with a health insurance system or entitled to coverage Exclusion Criteria: * Severe neurological disorder, identified by MRI and/or a neuro-pediatric assessment * Severe cognitive, child psychiatric, or developmental delay * Severe cochleo-vestibular malformation * Severe cochlear nerve malformation * Social circumstances preventing long-term follow-up * Family not proficient in spoken French * Patient fitted with a CROS or BiCROS system * Patient with a contraindication to implantation surgery or anesthesia (including lack of meningitis/pneumococcal vaccination)

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Conditions

The condition(s) this trial relates to.

deafness, unilateral Hearing Loss, Unilateral

As listed by the trial registrant

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

Asymmetric hearing loss Unilateral 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

    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")

    RECRUITING

    Paris, 75014, France

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