AUGUST 9, 2010 :: FOR IMMEDIATE RELEASE
Contact Rebecca Novak Tibbitt :: ph: (704) 341-1544 :: email: rebecca@rntcommunications.com
MED-EL Receives FDA
Approval for Amadé Audio
Processor
Leading the Vibrant Soundbridge Hearing
Prosthesis Into a New Generation
August 9, 2010 – (Durham, NC) – MED-EL
Corporation USA today announced that it has
received U.S. Food and Drug Administration
approval for the Amadé™ audio processor for use with the Vibrant Soundbridge® Middle Ear
Implant System. The Vibrant Soundbridge is designed to treat people with moderate to severe
sensorineural hearing loss and is the most successful middle ear hearing implant on the market.
The Amadé can be used by both new and existing Soundbridge users.
The Amadé distinguishes between speech and background noise and lets the user enjoy
communicating in a wide range of situations. Features of Amadé include:
Multiple Programs: personal control of three open-ended listening settings, tailored by an
audiologist. By simply using the push button, the user can effortlessly switch between
individualized programs.
Wind Noise Reduction: the processor constantly monitors the environment for wind noise
and reduces it automatically.
Sound Smoothing: annoying or distracting sounds in the environment are reduced without
interfering with speech.
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Speech and Noise Management: dual microphone technology focuses on speech and
automatically identifies and reduces background noise, especially from the sides and back
of the listener.
New Housing Design and Color Options: in addition to being 13% slimmer than the
previous audio processor, the Amadé features a new ergonomic housing design available in
four different colors: Dark Chocolate; Terra Brown; Golden Sand and Silver Grey.
“With the Amadé, we made a step forward into a new generation of audio processors. Following
an intensive development process, the user can now benefit from advanced technology and
additional features with the Amadé. From a patient’s point of view, the program switch we have
now is terrific, easy to use and has a great feel like the rest of the new audio processor,” said
Geoffrey Ball, scientist and inventor of the Vibrant Soundbridge. Geoff is bilaterally implanted
with the system and has over 30 years of medical device industry experience.
About the VIBRANT SOUNDBRIDGE
The Vibrant Soundbridge is the first FDA-approved implantable middle ear hearing device to
treat sensorineural hearing loss (the most common form of hearing loss). A proven, safe and
effective treatment that leaves the ear canal completely open, the Soundbridge features a 94%
improvement in patient satisfaction1, with thousands of patients worldwide.
The Vibrant Soundbridge is indicated for use in adults, 18 years of age or older. The
Soundbridge is intended to treat moderate to severe sensorineural hearing loss for patients who
cannot achieve success or adequate benefit from hearing aids or cannot medically tolerate
hearing aids. Prior to receiving the device, it is recommended that an individual have
experience with appropriately fit hearing aids.
The Vibrant Soundbridge offers a wide range of benefits including:
more natural quality of speech and sound,
transmission of high pitches (particularly relevant for listening to or playing music),
no feedback or whistling, and
high wearing comfort that leaves the ear canal completely free
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About MED-EL
MED-EL has set new standards in hearing implant technologies, developing and manufacturing
technologically advanced hearing solutions for people with varying degrees of hearing loss.
MED-EL hearing implant systems, currently used in 94 countries, combine the latest scientific
advances, engineering and manufacturing techniques for performance, safety and reliability.
MED-EL currently supports Soundbridge users in the United States as well as services the
device. For more information, visit www.medel.com.
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1. "94% increase in patient satisfaction for sound quality." Luetje C, et al. Phase III Clinical Trial results with the
Vibrant Soundbridge Implantable Middle Ear Hearing Device. Prospective Controlled Multicenter Study.
Otolaryngology-Head & Neck Surgery 2002; 126; 2:97-107.