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Active, Not Recruiting

NCT Number: NCT05615649

Expanded Indications in the Pediatric BONEBRIDGE Population

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hearing Loss, Conductive Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Mixed Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Health/Children's Hospital of Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED-EL BONEBRIDGE Bone Conduction Implant

Device

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

Primary outcomes

  1. Functional gain

    Time frame: Up to six (6) months post-activation

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

  2. Adverse events

    Time frame: Up to six (6) months post-activation

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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