SOUNDTEC's Implantable Hearing Device

July 2001 - SOUNDTEC Announces Implantable Hearing Device

September 2001 - SOUNDTEC Receives FDA Approval for Implantable Hearing Device

April 2002 - Implantable Hearing Device Company Foresees Growing Demand

July 2002 - LA Doctor Performs First California SOUNDTEC Implant

September 2002  - SOUNDTEC Receives FDA Approval for In-the-Canal Processor

SOUNDTEC Announces Implantable Hearing Device

Editor: It seems like just recently we were publishing our first article about an implantable hearing aid; now there are several either on the market or in the works. Here are portions of a press release on the new device from SOUNDTEC.

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SOUNDTEC, Inc. has reached three major milestones in the Food and Drug Administration's approval process of The Direct System implantable hearing device. First, in an exceptional move, the FDA has informed the company of their decision to forego formal Ear, Nose and Throat Devices Advisory Panel review. Second, SOUNDTEC has been notified that the FDA has filed the pre-market approval application (PMA) for The Direct System. Third, the FDA has recently concluded its inspection of the SOUNDTEC facility. The company is currently responding to the FDA's only recommendation.

It is unique for the FDA to allow a product to forego review by an approval panel. Foregoing the ENT Review Panel brings The Direct System implantable hearing device closer to FDA approval and thus, the marketplace. However, this does not preclude the FDA's current review of the application.

"SOUNDTEC, Inc. is very pleased with the FDA's decision to allow The Direct System to forego formal review by the ENT Advisory Panel," said Ted Davis, President of SOUNDTEC, Inc. "This means we are one step closer to making The Direct System available to those in need - people with mild/moderate to severe sensorineural hearing loss."

The Direct System implantable hearing device could change how the world deals with hearing loss. The procedure takes only 25 minutes under local anesthetic, and the cost is about the same as some hearing aid devices. In the implant procedure, the tissue between the eardrum and the ear canal is incised so that the eardrum becomes a "flap," through which the implant instruments can pass. A tiny, rare earth magnet that has been hermetically laser-welded in a titanium canister is then placed between the incus and the stapes. The eardrum "flap" is then replaced, completing the simple procedure.

"I began working to create The Direct System many years ago," said Dr. Jack Hough, founder of SOUNDTEC, Inc. and a renowned otologist who began revolutionizing ear surgery more than 40 years ago. "It is gratifying to think that we could be so close to our goal of helping the world to hear."

The Direct System's superior performance stems from its ability to increase the usable range of hearing or functional gain. The Direct System's processor accepts acoustic information and transmits it to the implanted magnet as electromagnetic waves, causing the magnet to vibrate. These vibrations actually drive the small bones of the middle ear, providing clear, familiar, full-fidelity sound.

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

The 103-patient clinical trial was intended to demonstrate that The Direct System minimizes acoustic feedback, minimizes occlusion effect and distortion. The Direct System also improves sound quality.

SOUNDTEC, Inc. was founded in 1997 by Dr. Jack Hough, an internationally respected otologist and founder of the Hough Ear Institute in Oklahoma City. The company's mission is to lead the world's development, manufacturing, and marketing of affordable hearing restoration products for persons with moderate to moderately severe impairments. The Direct System is the result of Dr. Hough's 20-year collaboration with a team of medical, technological, and engineering professionals to develop an affordable, less invasive hearing restoration device that will overcome the limitations inherent in traditional hearing devices.

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SOUNDTEC Receives FDA Approval for Implantable Hearing Device

November 2001

Editor: We've been hearing about implantable hearing aids for a while now, and SOUNDTEC has received FDA approval on The Direct System implantable hearing device. What I find exciting about this system is the potential for much clearer sound, because the system directly drives the hearing bones. It'll be interesting to watch ongoing development in this area.

Here are portions of their press release.

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SOUNDTEC, Inc. has received approval from the Food and Drug Administration for The Direct System implantable hearing device, a revolutionary device that could change how the world deals with hearing loss.

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-sealed 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 is about the same as top-quality digital hearing aids currently on the market.

The Direct System's superior 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. These vibrations are passed on to the small bones of the middle ear, providing clear, natural, high-fidelity sound.

The Direct System will 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 only mildly invasive, The Direct System is the logical alternative to conventional hearing instruments.

Conventional hearing aids have inherent limitations, often referred to as feedback, distortion and occlusion. Feedback is the squealing or whistling noise associated with most hearing aids. Many hearing aid wearers also experience distortion, when words and sounds seem muffled and garbled. Finally, tightly fitting hearing aid earmolds can cause occlusion, or the feeling that one is speaking from within a tunnel or barrel.

The Direct System was tested in a clinical trial - 103 patients at ten U.S. locations - intended to demonstrate that the device minimizes acoustic feedback, minimizes occlusion effect and distortion. The Direct System also improves sound quality. Because implantation is a surgical procedure - even though a minor one - a patient's ear needs time to heal, and to accustom itself to the tiny magnet. Normally, the patient can begin wearing the sound processor about eight to ten weeks following the implantation procedure.

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L.A. Doctor Performs First California SOUNDTEC Implant

July 2002

Editor: Last week we published an article about an SHHH presentation on implantable hearing aids. The bottom line, according to Dr. Gates, is that they offer real but small benefit over traditional hearing aids. It's been interesting that we've seen very little about their use in the real world - until now. Dr. James Andrews recently performed the first California implantation of the device. Here are portions of the press release.

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Dr. James Andrews of Pacific Head and Neck Specialists and Clinical Professor of Surgery at UCLA, has performed the first California implantation of the SOUNDTEC Direct System hearing device since the device received FDA approval in September.

The Direct System is a revolutionary new hearing device that could replace hearing aids for millions of Americans. Implantation took only thirty minutes and was performed in the doctor's office.

A 72-year-old Yuba City gentleman received the implant, then after allowing for complete healing, he received the speech/sound processor. For the first time in years, Donald Lehman is enjoying good sound quality and freedom from overwhelming background noise. He can clearly hear the sounds of nature, his family and even the television without using excessive volume.

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-sealed 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.

Conventional hearing aids have three inherent limitations, often referred to as feedback, distortion and occlusion. Feedback is the squealing or whistling noise associated with most hearing aids. Many hearing aid wearers also experience distortion, when words and sounds seem muffled and garbled. Finally, tightly fitting hearing aid earmolds can cause occlusion -- the feeling that one is speaking from within a tunnel, or that their ear is plugged.

The Direct System, approved by the FDA in September, can benefit a wide range of people. Anyone 18 years or older who exhibits mild/moderate to severe sensorineural (nerve) hearing loss may be able to benefit from the implantable device.

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

The Direct System was tested in a clinical trial -- 103 patients at ten U.S. locations -- which demonstrated that the device minimizes acoustic feedback, minimizes occlusion effect and distortion.

Implantable Hearing Device Company Foresees Growing Demand

April 2002

Editor: We've been following the development of the implantable hearing device for a couple of years now. There are two devices currently available and several others in the works; I haven't seen a technical comparison, but the technology of all seems similar. SOUNDTEC's Direct System seems to be the least expensive and require the least invasive surgery.

Here are portions of a recent press release.

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In 2002, Americans will spend about $2.6 billion on hearing devices. Since the market traditionally grows by 5% annually, sales of hearing aids or devices for the next decade could reach $35 billion in the United States alone. As baby boomers become golden- agers, the market will grow even more dramatically.

Since the first cave man cupped a hand around his ear to hear better, hearing aid methodology - to simply make sounds louder - has changed very little. But amplification, while it can be a reasonably effective treatment for the hard of hearing, has many inherent problems. These problems have contributed to the traditional lack of acceptance of hearing aids by the hard of hearing population. Though about one-tenth of the American population (28.6 million) have trouble hearing, only 6.6 million own hearing aids.

That may soon change. Privately held SOUNDTEC, inc., has recently introduced non-amplification technology they believe will revolutionize the hearing health industry. The device is not a hearing aid. Rather than simply amplify sound, SOUNDTEC's FDA- approved Direct System processor turns sound into electromagnetic waves which are received by a tiny rare-earth magnet implanted in the middle ear. The magnet passes the sound on to the inner ear in the form of vibrations, a process that simulates healthy hearing.

The result is clearer, more natural sound, and a drastic reduction in problems associated with conventional hearing aids. Implantation of the tiny magnet takes less than 30 minutes, and can be performed in an outpatient clinic under local anesthetic. This is much less invasive than other implantable devices. The Direct System is also much more affordable, costing about the same as top-quality digital hearing aids currently on the market.

SOUNDTEC believes the combination of 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.

As the forerunner and patent-holder of this innovative technology, SOUNDTEC is in a position to take full advantage of this expanding market universe. SOUNDTEC's Direct System provides clear, high-fidelity sounds without the problems associated with traditional hearing aids - feedback, distortion and occlusion. Feedback is the squealing or whistling noise associated with hearing aids. Many hearing aid wearers also experience distortion, when words or sounds seem muffled or garbled. Finally, tightly fitting hearing aids can cause occlusion, or the feeling that one's ears are plugged.

Millions of people could benefit from The Direct System. Anyone who is eighteen years of age or older, and who suffers from moderate to severe sensorineural hearing loss (nerve damage) is a potential candidate for The Direct System. SOUNDTEC was recently honored as Oklahoma's Innovator of the Year by the Journal Record Business Publication.

SOUNDTEC 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 first co- investigator on the Cochlear Implant device for the profoundly deaf.

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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SOUNDTEC Receives FDA Approval for In-the-Canal Processor

September 2002

Editor: The implantable hearing aid field continues to develop, with SOUNDTEC receiving FDA approval for their Integrated Processor and Coil component of the Direct System middle ear implantable hearing device. Here are portions of the press release.

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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.

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.