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Expanded Indications in the Pediatric BONEBRIDGE Population

Sponsor
Med-El Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05615649
Collaborator
(none)
36
Enrollment
6
Locations
1
Arm
27
Anticipated Duration (Months)
6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MED-EL BONEBRIDGE Bone Conduction Implant
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Expanded Indications in the Pediatric BONEBRIDGE Population
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional gain [Up to six (6) months post-activation]

      Postoperative improvement in aided soundfield thresholds compared to preoperative unaided soundfield thresholds

    2. Adverse events [Up to six (6) months post-activation]

      Number and proportion of subjects experiencing serious device- and surgery-related adverse events

    Secondary Outcome Measures

    1. Word recognition score [Up to six (6) months post-activation]

      Postoperative improvement on aided Consonant-Nucleus-Consonant (CNC) Words compared to preoperative unaided CNC word score

    2. Unaided bone-conduction pure-tone average (BC-PTA) [Up to three (3) months post-activation]

      Postoperative shift in unaided bone-conduction BC-PTA compared to preoperative unaided BC-PTA

    3. Post-intervention quality-of-life questionnaire [Up to six (6) months post-activation]

      Total and subscale scores on Glasgow Children's Benefit Inventory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Health/Children's Hospital of Colorado Aurora Colorado United States 80045
    2 University of Miami Miami Florida United States 33136
    3 University Hospital Newark/Rutgers New Jersey Medical School Newark New Jersey United States 07103
    4 University of North Carolina Chapel Hill North Carolina United States 27517
    5 The Ohio State University/Nationwide Children's Hospital Columbus Ohio United States 43210
    6 University of Utah Health/Primary Children's Hospital Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • Med-El Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Med-El Corporation
    ClinicalTrials.gov Identifier:
    NCT05615649
    Other Study ID Numbers:
    • G220197
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness
    Hearing Loss, Conductive
    Hearing Loss, Mixed Conductive-Sensorineural

    Study Results

    No Results Posted as of Jan 27, 2023