At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Expanded Indications in the Adult Cochlear Implant Population
In Brief
A clinical study evaluating MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System for Hearing Loss, Sensorineural. Completed, enrolled 44 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.