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New hearing implant shows promise for kids under five

NCT ID NCT06634784

Disease control Sponsor: MED-EL Elektromedizinische Geräte GesmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 9 children under 5 who received the BONEBRIDGE BCI 602 hearing implant. The main goal was to check if the implant is safe within the first year after surgery. Researchers also measured how much the implant improved hearing and quality of life. The implant is designed to help children with certain types of hearing loss hear better.

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

9 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2026

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.

Who is studied

Children under 5 years old with BONEBRIDGE BCI 602 implants

Ages

1 year to 9 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: Children who received the BONEBRIDGE BCI 602 implant before the age of five and have had the implant for at least 12 months. Ability to perform the German language test. Willingness and ability to undergo all tests required by the study. Signed and dated informed consent obtained before any study-specific procedure and collection of retrospective data. Exclusion Criteria: Inability to perform audiological tests due to psychological, emotional, or related physical disorders. Failure to meet any inclusion criteria. Any condition that, in the investigator's opinion, poses an increased risk to the patient or prevents full compliance or completion of the study.

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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.

Children under 5 years Hearing loss, conductive Hearing loss, mixed

Contacts and locations

Locations

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Universitätsklinikum Schleswig-Holstein, Klinik für Hals-, Nasen- und Ohrenheilkunde

    Lübeck, Schleswig-Holstein, 23562, Germany

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