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

Launched by COCHLEAR · Apr 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of cochlear implant that releases a medication called dexamethasone. The goal is to see how well this implant works over a long period of time for people with sensorineural hearing loss, which is a common type of hearing loss that affects the inner ear. The medication is designed to help reduce inflammation, which can improve the performance of the implant and the overall hearing experience for users.

To participate in the trial, you need to have already completed another study related to this implant and be willing to provide written consent. You should have received a specific type of cochlear implant as part of that study. However, if you have unrealistic expectations about what the implant can do, other disabilities that might affect your safety, or if you're currently involved in another clinical trial, you may not be eligible. Since the trial is not yet recruiting, you would need to wait until it starts to find out more details about what being a participant would involve.

Gender

ALL

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.