NCT05615649

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2023Jul 2026

First Submitted

Initial submission to the registry

November 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

November 7, 2022

Last Update Submit

September 23, 2025

Conditions

Hearing Loss, ConductiveHearing Loss, Mixed

Outcome Measures

Primary Outcomes (2)

  • Functional gain

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

    Up to six (6) months post-activation

  • Adverse events

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

    Up to six (6) months post-activation

Secondary Outcomes (3)

  • Word recognition score

    Up to six (6) months post-activation

  • Unaided bone-conduction pure-tone average (BC-PTA)

    Up to three (3) months post-activation

  • Post-intervention quality-of-life questionnaire

    Up to six (6) months post-activation

Study Arms (1)

Study procedure

EXPERIMENTAL

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

Interventions

MED-EL BONEBRIDGE Bone Conduction ImplantDEVICE

Subjects will be implanted with the MED-EL BONEBRIDGE Bone Conduction Implant System. Subjects will be fit with the appropriate external audio sound processor.

Also known as: BCI 602
Study procedure

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Health/Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University Hospital Newark/Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

The Ohio State University/Nationwide Children's Hospital

Columbus, Ohio, 43210, United States

Location

University of Utah Health/Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Hearing Loss, ConductiveHearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 14, 2022

Study Start

October 3, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Locations

US(6)