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One surgery instead of two for kids' hearing implants?

NCT ID NCT04039802

Symptom relief Sponsor: Radboud University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether placing a bone-anchored hearing implant in a single surgery is as safe as the traditional two-step approach in children aged 4 to 9. The single-stage method is already standard in adults, but many surgeons still use two surgeries for kids. The main question was whether the implant is more likely to be lost with one surgery compared to two.

What this could mean

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

Active substance
single-stage surgery
What this could lead to
If successful, this could make hearing implant surgery simpler for children by avoiding a second operation.
What could go wrong
This is a small, completed study comparing two surgical approaches, not testing a new treatment. Results may not apply to all children or implant types.

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

70 people

The number who actually took part.

Started

Sep 2019

Finished

Jul 2023

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

Patients 4 to 9 years old who are planned for treatment with a BAHI (BI300 implant) are considered candidates for the study. They will be approached for participation in the trial after they have chosen a Cochlear sound processor after thorough clinical and audiological testing and counseling. These patients are selected from a tertiary referral center

Ages

4 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 test group: * Age 4-9 years * Indication for percutaneous bone-anchored hearing implant surgery with a BI300 implant * Insertion using the linear incision technique Inclusion criteria control group: * Children who underwent implantation of a wide diameter implant using two- stage surgery between 2012 and 2018 at the Radboudumc * Age 4-9 at the time of surgery * Linear incision technique was used during surgery Exclusion Criteria test group: * Inability to show up at all follow-up visits * Patients undergoing re-implantation * Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus. * Insufficient bone thickness ≤1mm, since conversion to two-stage surgery will be advocated Exclusion Criteria control group * Follow-up duration less than 1 year. * Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment of implantation)

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Conditions

The condition(s) this trial relates to.

conductive hearing loss disorder hearing loss disorder Hearing Loss, Conductive

As listed by the trial registrant

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

Hearing impaired children Hearing impairment, conductive

Contacts and locations

Locations

  • Radboudumc

    Nijmegen, Gelderland, 6500hb, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.