Thanks Bob
I only wish this were as interesting to my daughter as it is to me... uh... the one without the implant LOL!!... however... I can't wait!
Elyse
-----Original Message-----
From: hohbob%40bellsouth.net">hohbob
bellsouth.net
To: Hearing_Aids%40yahoogroups.com">Hearing_Aidsyahoogroups.com
Sent: Wed, 27 Sep 2006 2:19 PM
Subject: [Hearing_Aids] FDA Green-Flags Advanced Bionics Harmony
Boston Scientific Announces FDA Approval of Harmony(TM) HiResolution
(R)
Bionic Ear System
NATICK, Mass., Sept. 27 /PRNewswire-FirstCall/ -- Boston Scientific
Corporation (NYSE: BSX - News) today announced the approval of its new
Harmony(TM) HiResolution® 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 http://www.bionicear.com or call
> 800-678-2575 for more information.
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 http://www.bostonscientific.com or
http://www.bionicear.com.
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.
CONTACT: Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
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