The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.