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Could a simple ear reflex test improve cochlear implants for kids?

NCT ID NCT07417956

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study looks at whether measuring the stapedius reflex (a tiny ear muscle reflex) can help program cochlear implants in children aged 0 to 7. Currently, programming relies on behavioral responses, which can be hard to get from very young kids. The researchers will test the reflex during routine follow-up visits at 3, 6, and 12 months after surgery. If the method is reliable, it could lead to better hearing and speech outcomes for children with hearing loss.

What this could mean

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

Active substance
Electrically evoked stapedius reflex threshold (eSRT) measurement
What this could lead to
If successful, this could make cochlear implant programming faster and more accurate for young children, potentially improving speech development.
What could go wrong
This is a small, early feasibility study with only 48 children. The measurement may not work in all kids or may not lead to better outcomes.

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.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

Aug 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.

Who is studied

The target population is pediatric children aged 0 to 7 years followed at a specialized center (Necker Hospital, Paris). In children under 7, cooperation with behavioral testing is often limited, making the use of robust objective markers crucial (Gordon et al., 2004). Pediatric data suggest that eSRT can be measured in the majority of children and corresponds closely to the C-level (Lorens et al., 2004; Bresnihan et al., 2001; Aini, 2022), with recently optimized protocols (Palani et al., 2022; Wolfe et al., 2017). The study includes children with unilateral or bilateral cochlear implants, across all implant manufacturers, reflecting real-world practice. Exclusion of children with unstable middle ear pathology reduces the risk of false-negative eSRT results related to tympano-ossicular transmission.

Ages

0 days to 7 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 0 to 7 years * Unilateral or bilateral cochlear implant * Normal tympanogram * No objection from either parent or legal guardian Exclusion Criteria: * Severe neurological disorder present before inclusion (identifiable by MRI and/or pediatric neurological assessment) * Unstable middle ear pathology on the day of inclusion (e.g., acute serous otitis, tympanic membrane perforation) * Documented abnormality or lesion of the facial nerve or stapedius muscle * Severe cognitive, psychiatric, or developmental delay at the day of inclusion * Family not fluent in oral French.

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

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

Hearing loss in children with unilateral or bilateral cochlear implants

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

  • Hôpital Necker Enfants Malades - Service d'ORL et chirurgie cervico-faciale

    RECRUITING

    Paris, Île-de-France Region, 75015, France

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