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