Status:
COMPLETED
Cochlear Implant With Dexamethasone Eluting Electrode Array
Lead Sponsor:
Cochlear
Collaborating Sponsors:
NAMSA
Avania
Conditions:
Sensorineural Hearing Loss
Bilateral Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04750642
Start Date
October 4 2021
End Date
February 23 2024
Last Update
April 22 2025
Active Locations (8)
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1
Rocky Mountain Ear Centre
Englewood, Colorado, United States, 80113
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
New York Eye & Ear infirmary of Mt. Sinai
New York, New York, United States, 10010
4
NYU Langone Medical Center
New York, New York, United States, 10017