Cochlear Implant With Dexamethasone Eluting Electrode Array

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CI632D Investigational Medical Device (IMD)	CI632D	-
CI632 Comparator Device	CI632	-

Primary Outcome Measures

Name	Time	Method
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative	Six months postoperative	The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.
Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D	Six months postoperative	Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only.

Secondary Outcome Measures

Name	Time	Method
Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups	Twelve months postoperative	Adverse events were recorded from baseline to 12 months postoperative.
Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative	Six months postoperative	Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.
Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative	Six months postoperative	Scores from the AzBio Sentences in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance.

Locations (8): Rocky Mountain Ear Centre
🇺🇸
Englewood, Colorado, United States
Fiona Stanley Hospital
🇦🇺
Murdoch, New South Wales, Australia
Royal Victorian Eye and Ear Hospital
🇦🇺
East Melbourne, Victoria, Australia
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Gilles Hospital
🇳🇿
Auckland, New Zealand
New York Eye & Ear infirmary of Mt. Sinai
🇺🇸
New York, New York, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Westmead Hospital
🇦🇺
Sydney, New South Wales, Australia