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Brain implant offers sound hope for deaf children born without ears

NCT ID NCT02102256

Disease control Sponsor: Laurie Eisenberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tested a special hearing device called an auditory brainstem implant in 10 children aged 2 to 5 who are profoundly deaf due to missing or damaged inner ear parts. Unlike a cochlear implant, this device is placed directly on the brainstem during surgery. The main goal was to see if the surgery is safe and if the implant can help children detect sounds. The children were followed for one year for safety and up to three years to check for any hearing benefit.

What this could mean

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

Active substance
Auditory brainstem implant (Nucleus 24 device)
What this could lead to
If this implant proves safe and helpful, it could give children born without inner ear structures some access to sound, potentially aiding communication.
What could go wrong
This is a very small, early feasibility study with only 10 children. The implant requires brain surgery and may not provide clear hearing. Long-term benefits are uncertain.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Mar 2014

Finished

Apr 2021

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

2 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: * Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis * If previously received a cochlear implant, must demonstrate lack of benefit from that device Exclusion Criteria: * Medical contraindication to craniotomy/intracranial surgery * Severe cognitive or developmental delays

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Conditions

The condition(s) this trial relates to.

Deafness hearing loss, autosomal recessive 118, with cochlear aplasia

As listed by the trial registrant

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

Bilateral cochlear aplasia Bilateral cochlear nerve deficiency Bilateral cochlear ossification secondary to meningitis Profound bilateral deafness due to

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90008, United States