Actively Recruiting
Study of the MED-EL Dexamethasone-Eluting Cochlear Implant Electrode CIDEXEL for Adults with Hearing Loss
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-12
60
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the MED-EL Cochlear Implant Mi1250 FLEX28 DEX CIDEXEL, a new cochlear implant device that incorporates the anti-inflammatory drug dexamethasone into its electrode array. This device is designed to reduce post-operative impedance caused by insertion trauma. The main goal is to confirm the safety and performance of this investigational device among patients needing cochlear implantation. The study involves implanting the CIDEXEL device along with compatible external audio and speech processor components. This device does not contain any human or animal tissue-derived materials. The study aims to compare speech intelligibility before implantation and six months after. Secondary measures include impedance telemetry, electrically evoked potentials, hearing preservation, quality of life assessments, surgical usability, speech tests in noise, hearing quality, wearing time, and safety through adverse event monitoring. Participants will be evaluated before implantation and at a six-month follow-up. Assessments include speech perception tests, hearing tests, quality of life questionnaires, and device performance measurements. Safety is tracked by recording any adverse events during follow-up. The total participation includes the implantation procedure and monitoring for at least six months to gather comprehensive data on device performance and safety.
CONDITIONS
Brief Title
Dexamethasone Eluting Cochlear Implant: a Pivotal Study
Research Team
S
Stefano Morettini, PhD
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