MED-EL Receives FDA Approval for Amadé Audio Processor

August 2010

Editor: You may know that the cochlear implant company Med-El also has the Vibrant Soundbridge (r) Middle Ear Implant System for treating moderate to severe sensorineural hearing loss. They have just received FDA approval for their new sound processor.

Here's their press release

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MED-EL Corporation USA today announced that it has received U.S. Food and Drug Administration approval for the Amadé(tm) audio processor for use with the Vibrant Soundbridge(r) 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.
- 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

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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