OSIRIS CLTD5858 V1.0
Research type
Research Study
Full 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
IRAS ID
348586
Contact name
Jaydip Ray
Contact email
Sponsor organisation
Cochlear Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 17 days
Research summary
Bone conduction hearing systems help improve hearing for people with impaired outer or middle ear structures by sending sound vibrations through the bone behind the ear directly to the inner ear (cochlea), where sound is processed. Some individuals with an existing bone conduction hearing implant (Cochlear™ Baha® Connect System) that connects through the skin (percutaneous) may experience problems such as pain or ongoing skin infections related to the device. These individuals may benefit from transitioning to a Cochlear™ Osia® System that sits completely under the skin (active transcutaneous), which aims to reduce these problems and may offer better hearing outcomes.
The OSIRIS clinical study will test the Cochlear Osia System to confirm the safety and performance of the latest generation Osia System. This study will also explore the benefits of the Osia System compared to the Baha Connect System. It will involve adults aged 18 or older who have already had the Baha Connect System for at least 6 months. These individuals will have mixed or conductive hearing loss in the ear implanted with the Baha Connect System. Study participants who agree to take part and meet the study criteria will undergo speech performance testing in both quiet and noisy environments, and provide ratings for various questionnaires.
The study will last for approximately 2.5 years and will enrol 20 study participants from up to 7 hospitals or clinics in the United Kingdom. The results aim to provide a better understanding of the benefits of transitioning to the Osia System.REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0030
Date of REC Opinion
11 Feb 2026
REC opinion
Further Information Favourable Opinion