Cochlear Implant With Dexamethasone Eluting Electrode Array
- Conditions
- Bilateral Hearing LossSensorineural Hearing Loss
- Interventions
- Device: CI632DDevice: CI632
- Registration Number
- NCT04750642
- Lead Sponsor
- Cochlear
- 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
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 randomisation groups measured through Custom Sound software during clinical visits. Six months Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits. Six months
- Secondary Outcome Measures
Name Time Method Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit. Six months Comparison of rate and type of device related adverse events between randomisation groups. Six months and twelve months
Trial Locations
- Locations (21)
University of California Los Angeles(UCLA), Medical center
🇺🇸Los Angeles, California, United States
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
St. George Hospital
🇳🇿Christchurch, New Zealand
Rocky Mountain Ear Centre
🇺🇸Englewood, Colorado, United States
Michigan Ear Institute
🇺🇸Novi, Michigan, United States
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
University of Iowa
🇺🇸Iowa City, Iowa, United States
Washington University School of medicine
🇺🇸Saint Louis, Missouri, United States
Gilles Hospital
🇳🇿Auckland, New Zealand
University Hospitals Cleveland Medical center
🇺🇸Cleveland, Ohio, United States
The Ohio State University Eye and Ear Institute at Wexner Medical Center
🇺🇸Columbus, Ohio, United States
New York Eye & Ear infirmary of Mt. Sinai
🇺🇸New York, New York, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Fiona Stanley Hospital
🇦🇺Murdoch, New South Wales, Australia
Royal Victorian Eye and Ear Hospital
🇦🇺East Melbourne, Victoria, Australia
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Hearts for Hearing
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic Rochester Foundation
🇺🇸Rochester, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States