Status:
COMPLETED
Expanded Indications in the Adult Cochlear Implant Population
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit ...
Detailed Description
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with th...
Eligibility Criteria
Inclusion
- Adults, 18 years of age or older at the time of implantation
- Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
- Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
- Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
- CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
- Evidence of appropriately fit hearing aids as determined by the audiologist
- Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
- Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
- If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
- Fluent in English
- No radiological contraindications
- Ability to undergo general anesthesia
- Appropriate motivation and expectation levels
- Stated willingness to comply with all study procedures for the duration of the study
Exclusion
- Evidence that hearing loss is retrocochlear in origin
- Active middle ear infection
- Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
- History of prior use of a hearing implant
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03236909
Start Date
April 16 2018
End Date
March 27 2023
Last Update
June 24 2025
Active Locations (5)
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1
University of Miami
Miami, Florida, United States, 33136
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Vanderbilt University
Nashville, Tennessee, United States, 37232
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226