Long-term Follow-up Study of Adults With CI632D and CI632 Cochlear Implants Evaluating Dexamethasone-Eluting Electrode Arrays and Hearing Outcomes

What this Trial Is About

Researchers are conducting a long-term follow-up study to evaluate a cochlear implant electrode array that passively releases dexamethasone to help reduce inflammation. This study involves adults with bilateral postlinguistic sensorineural hearing loss who have previously received either the CI632D cochlear implant with dexamethasone or the CI632 implant without dexamethasone. The purpose is to assess differences in device performance and safety over an extended period. Participants have already been implanted with either the CI632D investigational medical device or the CI632 comparator device under a previous study. This follow-up study observes these two groups to compare outcomes such as impedance measurements, device-related adverse events, acoustic hearing thresholds, and speech perception scores. The study collects data up to five years post-activation to monitor long-term effects of the dexamethasone-eluting electrode array. During the study, participants will undergo routine follow-up visits where various hearing and device function tests will be conducted. These include measuring impedance using monopolar and four-point methods, assessing low-frequency hearing with pure tone averages, and evaluating speech perception in quiet and noisy environments. Safety and adverse events related to the devices will also be recorded. The total participation duration extends up to five years after device activation to ensure comprehensive long-term monitoring.

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