Expanded Indications in the Pediatric BONEBRIDGE Population

November 13, 2023 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

36

Phase

  • 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 Locations

  • United States
    • Colorado
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Hillary Snapp, MD
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Not yet recruiting
        • University Hospital Newark/Rutgers New Jersey Medical School
        • Contact:
        • Principal Investigator:
          • Robert Jyung, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Anne Selleck, MD
        • Sub-Investigator:
          • Caitlin Sapp
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The Ohio State University/Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Oliver Adunka, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Not yet recruiting
        • University of Utah Health/Primary Children's Hospital
        • Contact:
        • Principal Investigator:
          • Neil S Patel, MD

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

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
Intervention / Treatment
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

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

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

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)

October 3, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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