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NOT YET RECRUITING
NCT07130136
NA

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

Sponsor: Cochlear

View on ClinicalTrials.gov

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

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).

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