Clinical Trial

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

Study acronym: OSIRIS
Recruiting
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Summary
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
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-21
Trial Details
NCT Number NCT07130136
Lead Sponsor Cochlear
Collaborators: TFS HealthScience
Conditions Bone Conduction, Hearing Loss, Conductive, Hearing Loss, Mixed
Enrollment 20 participants
Start Date 2026-07
Primary Completion 2028-11 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-20