RecruitingNCT06936449
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
Sponsor
Cochlear
Enrollment
19 participants
Start Date
May 5, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
DEVICECI632D
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
DEVICECI632
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06936449
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