Can smart cochlear implants help kids hear better in noise?
NCT ID NCT06400992
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
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 16 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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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).
RECRUITINGParis, 75015, France
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Other studies related to the condition(s) this trial covers.
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- A digital helping hand for new hearing aid wearers?