Osia 2 Pediatric Expansion Study

Exclusion Criteria

• •1. Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
• •2. Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
• •3. Abnormally progressive hearing loss.
• •4. Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
• •5. Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
• •6. Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor.
• •7. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• •8. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• •9. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• •10. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Osia 2 system as determined by the investigator.
• •11. Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.