Clinical Performance of the Osia 3 Sound Processor Compared with the Osia 2 Sound Processor in Adult Osia Implant Users

Inclusion Criteria:

• Implanted with a Cochlear Osia Implant (OSI100 or OSI200)

• Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2and 4 kHz) ≤ 55 dB HL.

OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) ≤ 20 dB HL in the good ear.

• Aged 18 years or older, at time of consent.

• Minimum experience of 1 month with the Osia 2 Sound Processor.

• Fluent speaker in the language used to assess speech perception performance.

• Willing and able to provide written informed consent.

Exclusion Criteria:

• Sensitivity to loud sounds.

• Ongoing infection at or around the sound processor area.

• Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator.

• Use of ototoxic drugs that could be harmful to the hearing, as judged by theinvestigator

• Investigator site personnel directly affiliated with this study and/or theirimmediate families; immediate family is defined as a spouse, parent, child, orsibling.

• Cochlear employees or employees of Contract Research Organisations or contractorsengaged by Cochlear for the purposes of this investigation.

• Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation).