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The Sentio System: Post-market Evaluation of Safety and Performance in Adolescents

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2025 to Aug 15, 2025
    v3
  2. Primary completion date: Nov 2025 to Apr 2027
    • Start date: May 2025 to Aug 2025
    • Study completion date: Jun 2026 to Aug 2027
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a post-market, multicentre, prospective, single arm investigation aimed to systematically collect safety and performance data on the Sentio system, when used as intended for adolescents (12-17 years inclusive).
Trial Details
NCT Number NCT06844071
Lead Sponsor Oticon Medical
Conditions
(from sponsor)		 Hearing Loss
Related terms Hearing Loss
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov