Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 from appropriately fit hearing aids.
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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