September 28, 2006
Boston Scientific nets FDA approval
By Jeff Lavery
Boston Scientific Corp. announced FDA approval of its Harmony HiResolution Bionic Ear System, a device that delivers 120 spectral bands that help to increase the hearing potential for the severe-to-profoundly deaf.
The device also received approval from Health Canada and the CE mark in Europe. The Harmony System is designed with the aim of improving music appreciation in difficult hearing environments, and helps to create a more natural representation of sounds.
In testing, 80 percent of the subjects gave the ear system a positive rating.
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