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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
Sponsor: Cochlear
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
Official title: Post-Market Clinical Follow-Up of the Osia System and Evaluation of Benefits of Transitioning From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients With Mixed or Conductive Hearing Loss
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05
Completion Date
2028-12
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Cochlear™ Osia® System
The Osia System consists of the OSI300 Implant, Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, Osia 2 Sound Processor Magnet Tool, Osia Fitting Software 2 (OFS 2), and Osia Smart App.
Cochlear™ Baha® System
The Baha Connect System consists of the BIA300 (BI300 Implant and BA300 Abutment), Baha 7 Sound Processor, and Baha Fitting Software 7 (BFS 7).
Locations (3)
Royal National Ear, Nose and Throat and Eastman Dental Hospitals
London, United Kingdom
Nottingham Auditory Implant Programme
Nottingham, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom