Expanded Indications in the Adult Cochlear Implant Population

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03236909
Study type	Interventional
Source	Med-El Corporation
Contact
Status	Completed
Phase	N/A
Start date	April 16, 2018
Completion date	March 27, 2023

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