Clinical Trial: Dexamethasone Eluting Cochlear Implant: a Pivotal Study
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Cochlear Implant
Study Type: INTERVENTIONAL
Official Title: Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study
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.
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