Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study

A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

Inclusion Criteria:

• Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
• Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
• Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
• Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.