Expanded Indications in the Adult Cochlear Implant Population

  • STATUS
    Not Recruiting
  • days left to enroll
    18
  • participants needed
    50
  • sponsor
    Med-El Corporation
Updated on 10 October 2022
anesthesia
deafness
cochlear implant
AIDS
profound sensorineural hearing loss

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.

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.

Details
Condition Hearing Loss, Sensorineural
Treatment MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
Clinical Study IdentifierNCT03236909
SponsorMed-El Corporation
Last Modified on10 October 2022

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