Patrick W. Slater II, M.D. implanted the very first patient in Austin, Texas, with the Direct System implantable hearing device. SOUNDTEC, Inc. 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, in September of last year.

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 is performed in Dr. Slater’s office under local anesthetic. The cost is about the same as top-quality digital hearing aids currently on the market.

“This device had been in development and research for twenty years and is now available to those in need – people with mild/moderate to severe sensorineural (or nerve) hearing loss." said Dr. Slater.

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 ccepts 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.

The Direct System was developed by SOUNDTEC, Inc. SOUNDTEC, Inc was founded in 1997 by Dr. Jack Hough, an internationally respected otologist and founder of the Hough Ear Institute in Oklahoma City, one of the world’s preeminent hearing research centers. 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 hearing 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.