ACTIVE_NOT_RECRUITING

Expanded Indications in the Pediatric BONEBRIDGE Population

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Conditions

Hearing Loss, ConductiveHearing Loss, Mixed

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Expanded Indications in the Pediatric BONEBRIDGE Population

Quick Facts

Study Start:2023-10-03
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05615649

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.

Ages Eligible for Study:3 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Under 12 years of age
  2. * 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
  3. * Sufficient air-bone gap (ABG) at in the ear to be implanted
  4. * HRCT scan that confirms sufficient bone quantity and quality to recess and fix the BCI in the ear to be implanted
  5. * Developmental, cognitive, and language skills needed to provide an unaided speech recognition threshold (SRT) in quiet with English spondees
  6. * Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
  7. * Parental commitment to comply with all study procedures
  1. * Children under 3 years (36 months) of age
  2. * Chronic or non-revisable vestibular or balance disorders
  3. * Abnormally progressive hearing loss
  4. * Prior use of a hearing implant in the ear to be implanted
  5. * Current/ongoing use of a hearing implant in the contralateral/non-implant ear
  6. * Evidence that hearing loss is retrocochlear in origin
  7. * Medical condition that contraindicates implant surgery or anesthesia
  8. * Skin or scalp condition precluding use of external audio processor

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-10-03
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-10-03
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Hearing Loss, Conductive
  • Hearing Loss, Mixed