Expanded Indications in the Adult Cochlear Implant Population

MED-EL

Status

Completed

Conditions

Hearing Loss, Sensorineural

Treatments

Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03236909

G170111

Details and patient eligibility

About

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.

Full 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 the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .

Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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