Lead Sponsor

Cochlear

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Implanted with a Cochlear Osia Implant (OSI100, OSI200, OSI300)
•Conductive or mixed hearing loss in the implanted ear. Bone conduction thresholds up to 65 dB HL (up to 40 dB HL at 0.5 kHz, up to 55 dB HL at 1kHz and up to 65 dB HL at 2 and 4 kHz) or Single-Sided Deafness in the implanted ear. The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and, 3 kHz).
•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.

•Ongoing infection at or around the sound processor area.
•Bilaterally implanted with a Cochlear Osia Implant.
•Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
•Use of ototoxic drugs that could be harmful to the hearing, as judged 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 employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
•Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Related studies

NCT06058767 · Hearing Loss, Hearing Disorders in Children, and more

NCT06734039 · Hearing Loss, Unilateral, Cochlear Implants, and more

NCT04793412 · Asymmetric Hearing Loss, Single-sided Deafness, and more

NCT07130136 · Bone Conduction, Hearing Loss, Conductive, and more

NCT06338670 · Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive

Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients