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Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients

Study acronym: OSIRIS
StatusRecruiting
PhaseNot applicable
SponsorCochlear
Started
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Record History

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  1. Start date: Jun 24, 2026 to Jul 24, 2026v7
  2. Start date changed from estimate of Jul 2026 to Jun 24, 2026
    • Site details revised at 1 of 3 sites
    v6
  3. Recruitment opened
    • Site details revised at 3 of 3 sites
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date: May 2026 to Jul 2026v3
  6. Primary completion date: Jun 2027 to Nov 2028v2 Show 6 more changesShow less
    • Start date: Dec 2025 to May 2026
    • Enrollment target: 18 to 20
    • Study sites: 4 to 3
    • Study completion date: Oct 2027 to Dec 2028
    • Secondary endpoints reordered
    • Eligibility criteria shortened, about 2 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Cochlear
28 trials monitored
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The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System. The main questions this study aims to answer are: * Is the safety and performance of the Osia System confirmed by study findings? * What are the benefits of the Osia System compared to the Baha Connect System? Participants will: * Undergo speech performance testing in both quiet and noisy environments * Provide ratings for various questionnaires
Trial Details
NCT Number NCT07130136
Lead Sponsor Cochlear
Collaborators: TFS HealthScience
Conditions
(from sponsor)		 Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
Related terms Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Patient Satisfaction
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov