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

Recruiting now

Conditions studied: Sensorineural Hearing Loss, Bilateral Hearing Loss

In brief

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.

Key facts

Study ID

NCT06936449

Run by

Cochlear

People needed

19

Starts

2025-05-05

Expected to finish

2028-03-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rocky Mountain Ear Center — Englewood, Colorado, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University Hospitals Cleveland — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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