Dexamethasone Eluting Cochlear Implant: a Pivotal Study
NCT: NCT06142682 · COMPLETED
NCT IDNCT06142682
StatusCOMPLETED
Start Date2024-09-02
Completion2026-08-18
SponsorMED-EL Elektromedizinische Geräte GesmbH (INDUSTRY)
First posted
Last updated
Brief Summary
The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain confirmatory data concerning safety and performances of the investigational device in the clinical population.
Official Source
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