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SOUNDTEC Receives FDA Approval for In-The-Ear Processor

OKLAHOMA CITY -- SOUNDTEC, Inc., manufacturer of the Direct System middle ear implantable hearing device, has received FDA approval for a new sound processor that is worn in the ear canal. SOUNDTEC's new Integrated Processor and Coil (IPC) will now be available as a part of the Direct System for more than 20 million consumers throughout the U.S. who have mild to moderate sensorineural hearing loss (nerve damage).

The Direct System consists of a tiny, rare-earth magnet implanted in the middle ear, and a speech/sound processor. Implantation of the tiny magnet takes less than 30 minutes, and can be performed in an outpatient clinic under local anesthetic. The Direct System is capable of eliminating or reducing the major complaints historically associated with conventional acoustic hearing aids, such as feedback, occlusion effect, and distortion. Typically, the Direct System costs about the same as top-quality digital hearing aids currently on the market.

"We've listened to the public and responded to consumers' needs and wishes by designing the smaller in-the-ear processor and acquiring FDA approval," said Steve Hawkins, SOUNDTEC Vice-President of Sales and Marketing. "Our current Direct System users have enjoyed the hearing benefits of our product, and now we have addressed the cosmetic issue to make the product more pleasing for the user," Hawkins said.

Initial FDA approval of the Direct System using a behind-the-ear processor was granted in September 2001. Professionals say that this is truly the "common sense" approach to this type of technology and doesn't require the patient to endure a major surgery and the enormous costs associated with that type of procedure.

The Direct System, unlike a hearing aid which simply amplifies sound, turns sound into electromagnetic waves which vibrate a tiny rare-earth magnet implanted in the middle ear. These vibrations are passed on to the inner ear simulating the natural hearing process.

"The combination of the Direct System's clearer, more natural sound, a comparatively simple implantation procedure, and affordable cost will have a powerful effect on the hearing aid market -- particularly with those who have resisted hearing devices in the past," said Ted Davis, President of SOUNDTEC, Inc.

Persons eighteen years of age or older, suffering from mild to moderate sensorineural hearing loss (nerve damage) are potential candidates for the Direct System.

Oklahoma City-based SOUNDTEC, Inc. was co-founded in 1997 by Kenneth Dormer, Ph.D., and Jack Hough, M.D., a renowned otologist and founder of the Hough Ear Institute, one of the world's pre-eminent hearing research centers. Dr. Hough was also one of the first co-investigators for the cochlear implant. SOUNDTEC's proprietary technology is protected by three U.S. patents and has patent protection in nine countries. Today, over 350 hearing health professionals throughout the United States, Canada, and some foreign countries have been trained to offer the Direct System implantable hearing device.

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