Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Recruiting
N/A
Interventional Study
Bone Conduction
Hearing Loss, Conductive
Hearing Loss, Mixed
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Cochlear · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 18 years of age or older
* Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect)
* Mixed or conductive hearing loss in the ear implanted with the Baha Connect System
* Bone conduction thresholds with pure tone average (P…
Contacts