NCT06936449Recruiting
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Cochlear
Start Date
5/5/2025
Completion Date
3/1/2028
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
Age Range: 18 years to No maximum
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.
Interventions
DEVICE
CI632D
DEVICE
CI632
Conditions
Sensorineural Hearing LossBilateral Hearing Loss
Locations
Rocky Mountain Ear Center
Englewood, Colorado 80113
United States
University of Iowa
Iowa City, Iowa 52242
United States
University Hospitals Cleveland
Cleveland, Ohio 44106
United States