Cochlear Implant With Dexamethasone Eluting Electrode Array

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

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.

Inclusion Criteria:

• Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
• 18 years or older at time of consent.

Exclusion Criteria:

• Abnormal cochlear and middle ear anatomy
• History with cochlear implant surgery
• Allergy to dexamethasone
• Women who are pregnant or plan to become pregnant
• Unable/unwilling to comply to study requirements