NCT07130136

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bone Conduction
• Hearing Loss, Conductive
• Hearing Loss, Mixed

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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).

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-11-01
• Completion: 2028-12-01
• First posted: 2025-08-19
• Last updated: 2026-02-11

Locations

3 sites across 1 country: United Kingdom