Boston Scientific has announced today’s FDA approval of its cochlear implant Harmony™ HiResolution® Bionic Ear System, a device designed for severely deaf patients.
Developed by the Company’s Neuromodulation Group, the Harmony System delivers 120 spectral bands, 5 – 10 times more than competing systems, helping to significantly increase hearing potential and quality of life for the severe-to-profoundly deaf.
“The Harmony System represents the next generation of cochlear implant technology,” said Jeff Greiner, President of Boston Scientific’s Neuromodulation Group. “We have brought together unprecedented advancements in science, design and functionality for the user — furthering our commitment to restoring hearing and improving quality of life for those living with hearing loss due to permanent inner ear or auditory nerve damage.”
Designed to enhance music appreciation and improve hearing in a variety of difficult listening environments, the Harmony System couples revolutionary internal sound processing (with the optional HiRes Fidelity™ 120) with the new Harmony behind-the-ear (BTE) external sound processor. Together, the two key components of the Harmony System are designed to provide significantly enhanced spectral resolution compared to conventional systems for a more natural representation of sound to help improve patient performance…
Cochlear implant users can access soft whispers and loud sounds without adjusting dials or controls with Harmony’s CD-quality processing and sophisticated dual-loop automatic gain control, helping users better appreciate music, hear in noisy environments, use the telephone, and hear sounds that are loud and soft.
In addition to the FDA approval, the Harmony HiResolution Bionic Ear System recently received approval from Health Canada and the CE mark in Europe.
According to clinical evaluation results, approximately 80 percent of the subjects reported a strong preference for the Harmony sound processor with HiRes Fidelity 120, most noting that they had improved clarity of speech and/or that environmental sounds were clearer and easier to distinguish.
The HiResolution Bionic Ear System with optional HiRes Fidelity 120 is approved in the U.S. for adults only at this time and for all patients in Canada and Europe. The product is expected to be available in early 2007.