Newspaper article THE JOURNAL RECORD

Soundtec Foresees Swift FDA Approval

Newspaper article THE JOURNAL RECORD

Soundtec Foresees Swift FDA Approval

Article excerpt

Officials with Soundtec Inc. say they expect to receive approval from the Food and Drug Administration for The Direct System implantable hearing device, perhaps as soon as this week.

Such swift approval is very rare.

In addition, company officials are scheduled to discuss The Direct System on Tuesday, Sept. 4, on The Today Show and CBS' The Early Show.

The Direct System consists of two components, a tiny rare-earth magnet and a sound processor. In the implant procedure, the tissue between the eardrum and the ear canal is incised so that the eardrum becomes a flap, giving access to the middle ear. The micro-magnet, which has been hermetically laser-welded in a titanium canister, is then placed on a segment of the three tiny bones in the middle ear. The eardrum flap is then closed, completing the simple procedure.

The procedure takes less than 30 minutes, and can be performed in a procedure room or outpatient clinic under local anesthetic. The cost -- about the same as a top-quality digital hearing aid -- is substantially less than that of other implantable devices.

"Soundtec is hopeful that we will soon receive FDA Approval for The Direct System implantable hearing device," said Ted Davis, president of Soundtec. "After 20 years of research, we will be able to make The Direct System available to those in need -- people with mild/moderate to severe sensorineural hearing loss."

The Direct System's performance stems from its ability to increase the usable range of hearing or functional gain. The Direct System's sound processor accepts acoustic information and transmits it to the tiny magnet as electromagnetic waves, causing it to vibrate and move the bones of the middle ear, duplicating the ear's natural functions. The vibrations are passed on to the small bones of the middle ear, providing clear, natural, high-fidelity sound.

The Direct System could benefit a wide range of people. Anyone 18 years or older who exhibits mild/moderate to severe sensorineural hearing loss may be able to benefit from the implantable device. Because this procedure is so much less invasive than other implants, The Direct System is the logical alternative to conventional hearing instruments. …

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