Osia CPT Code Study

A Post-market Interventional Cohort Study Evaluating the Clinical Efficacy of the Osia 2 System in the US Market.

To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.

Inclusion Criteria:

• Willing and able to provide written informed consent.
• Proficient in English.
• Hearing loss etiology of Conductive or Mixed Conductive loss.
• Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
• Aged 18 years and older.

Exclusion Criteria:

• Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
• 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 employees or contractors engaged by Cochlear for the purposes of this investigation.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
• Prior experience with a surgical bone conduction treatment option
• Insufficient bone quality to support the BI300 implant as determined by the surgeon