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NCT06936449Recruiting

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

Cochlear

Start Date

5/5/2025

Completion Date

3/1/2028

Summary

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

CI632D

DEVICE

CI632

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Conditions

Sensorineural Hearing LossBilateral Hearing Loss

Locations

Rocky Mountain Ear Center

Englewood, Colorado 80113

United States

University of Iowa

Iowa City, Iowa 52242

United States

University Hospitals Cleveland

Cleveland, Ohio 44106

United States