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Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
RecruitingObservational study
Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the 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.
What is being tested
- CI632D (device)
- CI632 (device)
Sponsor: Cochlear · Participants: 19 · Started: May 5, 2025
Contact the study team
- PRS Specialist · Phone: +61 2 9428 6555
Official record on ClinicalTrials.gov — NCT06936449
Locations in the U.S.
| Colorado | Rocky Mountain Ear Center, Englewood |
| Iowa | University of Iowa, Iowa City |
| Ohio | University Hospitals Cleveland, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.