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FDA grants first cochlear implant indication

Updated: Jul 24, 2019

“Hearing device maker MED-EL said it received FDA’s first-ever approval for a cochlear implant system for asymmetric hearing loss and single-sided deafness.

With both conditions, people have difficulty hearing, particularly in noisy environments. The FDA indications were based on a study at the University of North Carolina at Chapel Hill that evaluated speech perception in quiet and noise, sound localization and quality of life in 40 participants age 18 and older.” (Medtechdive, July, 2019)

source: medtechdive

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