Vibrant Soundbridge
FDA Approves Symphonix Devices' Vibrant Soundbridge Hearing Aid
Symphonix Devices, Inc. Introduces the Vibrant Soundbridge
Editor: The Vibrant Soundbridge Hearing Aid is another of the
implantable hearing aids that are starting to hit the market. This
system works through mechanical coupling to the hearing bones, rather
than by amplifying sound. Here are excerpts from the press
release:
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September 2000
The Food and Drug Administration Thursday said it approved Symphonix
Devices Inc.'s Vibrant Soundbridge implantable hearing aid for use in
the U.S.
The FDA approved the Symphonix product as the first implanted hearing
device of its kind for a type of moderate-to-severe nerve hearing loss
that afflicts millions of Americans. The loss is caused by problems with
nerves vital for sound, an Associated Press report said.
Regular hearing aids help many of these people by magnifying sound.
The Soundbridge works very differently: It converts sound to the
mechanical vibrations of the delicate middle ear bones - the way normal
sound moves those bones, the AP reported.
The device also isn't as noticeable as standard hearing aids.
To implant the Soundbridge, a doctor places a microphone and battery
on the patient's scalp. The microphone transmits sound through the skin
to a receiver surgically implanted behind the ear. A wire leads down to
a small electromagnet implanted in the middle ear that drives the
vibrations.
The implant is different from another surgical treatment, cochlear
implants, for the profoundly deaf. Cochlear implants are electronic
systems that send sound-generated impulses to the brain to bypass a flaw
in the inner ear.
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April 2001
Editor: Symphonix Devices, Inc. introduced their The Vibrant(r)
Soundbridge (TM) device at the recent American Academy of Audiology
(AAA) convention. The Soundbridge is an implantable middle ear hearing
device (IMEHD) designed to treat moderate to severe sensorineural
hearing loss. It provides yet another new treatment option for people
with hearing loss.
Here are portions of their press release.
~~~~~~~~~~~~~~~~~~~
The Vibrant(r) Soundbridge (TM) will be the subject of 10
presentations at the 13th Annual Convention of the American Academy of
Audiology (AAA), taking place next week in San Diego, Calif., stated
Kirk Davis, president and chief executive officer of Symphonix Devices,
Inc. (Nasdaq: SMPX - news). The Vibrant Soundbridge is an implantable
middle ear hearing device (IMEHD) designed to treat moderate to severe
sensorineural hearing loss, the most common form of hearing impairment.
"The Vibrant Soundbridge offers audiologists a new treatment
option for appropriate patients", said Elizabeth Coughlin, M.S., a
practicing audiologist and instructor for the course entitled
`Incorporating the Vibrant Soundbridge Into Your Practice'. "The
device expands our ability to better help some of our current patients,
while also drawing in others who may not have considered using an
assistive device previously. By doing so, it holds promise to positively
affect people's lives and our practices in meaningful ways."
"Our initial outreach to audiologists has been met with a
favorable response, so we are looking to the AAA as a prime venue for
introducing the Vibrant Soundbridge to the greater audiology
community," said Davis. "This educational outreach marks the
next milestone in our marketing strategy. In the first phase we focused
on building a strong foundation of support from ear, nose and throat
surgeons. Now we have a nationwide network of more than 35 surgical
Centers of Excellence in place and are focusing on introducing the
device to audiologists, who are the primary hearing healthcare-givers
and a significant, trusted source of information for patients seeking
treatment for their hearing loss.''
About Symphonix
Founded in 1994, Symphonix Devices, Inc. is a hearing technology
company dedicated to developing a family of products to improve
communication ability and quality of life for the millions of
hearing-impaired individuals limited by current hearing solutions.
Symphonix' Vibrant Soundbridge is a surgical implant designed to work
with the natural structures of the middle ear to enhance hearing and
communication ability for people with hearing impairment. The device can
be implanted during a short, outpatient surgical procedure.
