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New implant could help deaf children hear without traditional aids

NCT ID NCT05615649

Disease control Sponsor: Med-El Corporation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study is testing a device called the BONEBRIDGE, a bone conduction implant that helps people with certain types of hearing loss hear better. The implant is placed under the skin behind the ear during surgery and works by sending sound vibrations through the skull bone directly to the inner ear. The trial includes 36 children under 12 years old with conductive or mixed hearing loss. Researchers are checking if the device is safe and improves hearing compared to before surgery.

What this could mean

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

Active substance
BONEBRIDGE bone conduction implant (a surgically placed device that sends sound vibrations through the skull to the inner ear)
What this could lead to
If successful, this could provide a safe, effective hearing solution for young children with certain types of hearing loss who cannot use standard hearing aids.
What could go wrong
This is a small, early-stage study (36 children) focused on safety and basic hearing improvement. The device requires surgery, which carries risks like infection or implant failure. Results may not apply to all types of hearing loss.

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

36 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 12 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: * Under 12 years of age * Unaided bone-conduction thresholds at 0.5, 1, 2, and 4 kHz better than or equal to 45 dB HL in the ear to be implanted * Sufficient air-bone gap (ABG) at in the ear to be implanted * HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted * Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees * Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons * Parental commitment to comply with all study procedures Exclusion Criteria: * Children under 3 years (36 months) of age * Chronic or non-revisable vestibular or balance disorders * Abnormally progressive hearing loss * Prior use of a hearing implant in the ear to be implanted * Current/ongoing use of a hearing implant in the contralateral/non-implant ear * Evidence that hearing loss is retrocochlear in origin * Medical condition that contraindicates implant surgery or anesthesia * Skin or scalp condition precluding use of external audio processor

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Conditions

The condition(s) this trial relates to.

conductive hearing loss disorder Hearing Loss, Conductive hearing loss, mixed conductive-sensorineural

As listed by the trial registrant

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

Hearing loss, conductive Hearing loss, mixed

Contacts and locations

Locations

  • The Ohio State University/Nationwide Children's Hospital

    Columbus, Ohio, 43210, United States

  • University Hospital Newark/Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • University of Colorado Health/Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27517, United States

  • University of Utah Health/Primary Children's Hospital

    Salt Lake City, Utah, 84132, United States

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