CI632D: CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
CI632: CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits. — 5 years post-activation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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