Expanded Indications in the Pediatric BONEBRIDGE Population

August 17, 2026 updated by: Med-El Corporation
This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective multicenter IDE study will include 36 children implanted with the MED-EL BONEBRIDGE system at six academic medical centers across the US.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health/Children's Hospital of Colorado
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • University Hospital Newark/Rutgers New Jersey Medical School
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University/Nationwide Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health/Primary Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study procedure
This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.
Device: MED-EL BONEBRIDGE Bone Conduction Implant
Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.
Other Names:
  • BCI 602

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional gain
Time Frame: Up to six (6) months post-activation
Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds
Up to six (6) months post-activation
Adverse events
Time Frame: Up to six (6) months post-activation
Number and proportion of subjects experiencing serious device- and surgery-related adverse events
Up to six (6) months post-activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Word recognition score
Time Frame: Up to six (6) months post-activation
Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score
Up to six (6) months post-activation
Unaided bone-conduction pure-tone average (BC-PTA)
Time Frame: Up to three (3) months post-activation
Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA
Up to three (3) months post-activation
Post-intervention quality-of-life questionnaire
Time Frame: Up to six (6) months post-activation
Total and subscale scores on Glasgow Children's Benefit Inventory
Up to six (6) months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Med-El Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G220197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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