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

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

Recruiting
18 years and older
All
Phase N/A
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Overview

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.

Eligibility

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.

Study details
    Sensorineural Hearing Loss
    Bilateral Hearing Loss

NCT06936449

Cochlear

15 October 2025

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