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
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 (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System
Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear)
Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
Cochlear
Lead sponsor
TFS HealthScience
Collaborator