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Pediatric Expansion Study of the Sentio System

Study acronym: BC119
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 14, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment closed, study ongoing
    • Site details revised at 8 of 8 sites
    v5
  2. Site details revised at 1 of 8 sitesv4
  3. Site details revised at 1 of 8 sitesv3
  4. Site details revised at 5 of 8 sitesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.
Trial Details
NCT Number NCT06976086
Lead Sponsor Oticon Medical
Collaborators: Guy's and St Thomas' NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Radboud University Medical Center, Hospital Universitario La Fe, Hospital Universitario Virgen Macarena, Hospital Donostia
Conditions
(from sponsor)		 Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
Related terms Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov