Boston Scientific Corporation (NYSE: BSX) today announced the approval of its new Harmony(TM) HiResolution(R) Bionic Ear System (Harmony System) by the U.S. Food and
Drug Administration (FDA). 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(TM) 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.
"With the new Harmony System, we are able to actively steer electrical
currents with a high degree of accuracy, increasing the number of spectral
bands from 16 to 120," said Greiner. "We are attempting to guide precise
pitch information into the cochlea by taking advantage of surviving neural
populations to help increase the user's ability to hear in noisy
environments and to better appreciate the intricate sounds of music."
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.
People interested in bionic ear technology to restore hearing should
speak to their physicians and visit bionicear.
Boston Scientific is a worldwide developer, manufacturer and marketer
of medical devices whose products are used in a broad range of
interventional medical specialties. The Neuromodulation Group is a global
leader in the development of implantable, high-technology neurostimulation
devices that include treatments for deafness and chronic pain. For more
information, please visit bostonscientific/ or
bionicear.
This press release contains forward-looking statements. Boston
Scientific wishes to caution the reader of this press release that actual
results may differ from those discussed in the forward-looking statements
and may be adversely affected by, among other things, risks associated with
new product development and commercialization, clinical trials,
intellectual property, regulatory approvals, competitive offerings,
integration of acquired companies, Boston Scientific's overall business
strategy, and other factors described in Boston Scientific's filings with
the Securities and Exchange Commission.
Boston Scientific Corporation
bostonscientific/