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Recruiting NCT06936449

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

Conditions: Sensorineural Hearing Loss, Bilateral Hearing Loss

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 19
Sponsor: Cochlear

Location: Rocky Mountain Ear Center Englewood Colorado

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06936449). StuddyBuddy aggregates publicly available trial information.