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Expanded Indications in the Pediatric BONEBRIDGE Population

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Jul 2026 → Oct 2026
See other at-risk trials from Med-El Corporation

Record History

  1. Primary and study completion pushed from Jul 2026 to Oct 2026v10
  2. Primary completion date: Jan 2026 to Jul 2026v9
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 2025 to Jan 2026
    • Study completion date: Aug 2025 to Jul 2026
    • Site details revised at 6 of 6 sites
    v8
  4. Site details revised at 2 of 6 sitesv7
  5. Start date changed from estimate of Sep 2023 to Oct 3, 2023v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Aug 2023 to Sep 2023
    • Site details revised at 2 of 6 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2023 to Aug 2023
    • Primary and study completion dates: Jun 2025 to Aug 2025
    • Site details revised at 6 of 6 sites
    v4
  3. Start date: Mar 2023 to Jun 2023v3
  4. Start date: Dec 2022 to Mar 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05615649
Lead Sponsor Med-El Corporation
Conditions
(from sponsor)		 Hearing Loss, Conductive, Hearing Loss, Mixed
Related terms Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov