Vibrant Soundbridge

Vibrant Soundbridge

FDA Approves Symphonix Devices’ Vibrant Soundbridge Hearing Aid

Symphonix Devices, Inc. Introduces the Vibrant Soundbridge

FDA Approves Symphonix Devices’ Vibrant Soundbridge Hearing Aid

Editor: The Vibrant Soundbridge Hearing Aid is another of the implantable hearing aids that are starting to hit the market. This system works through mechanical coupling to the hearing bones, rather than by amplifying sound. Here are excerpts from the press release:

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September 2000

The Food and Drug Administration Thursday said it approved Symphonix Devices Inc.’s Vibrant Soundbridge implantable hearing aid for use in the U.S.

The FDA approved the Symphonix product as the first implanted hearing device of its kind for a type of moderate-to-severe nerve hearing loss that afflicts millions of Americans. The loss is caused by problems with nerves vital for sound, an Associated Press report said.

Regular hearing aids help many of these people by magnifying sound. The Soundbridge works very differently: It converts sound to the mechanical vibrations of the delicate middle ear bones – the way normal sound moves those bones, the AP reported.

The device also isn’t as noticeable as standard hearing aids.

To implant the Soundbridge, a doctor places a microphone and battery on the patient’s scalp. The microphone transmits sound through the skin to a receiver surgically implanted behind the ear. A wire leads down to a small electromagnet implanted in the middle ear that drives the vibrations.

The implant is different from another surgical treatment, cochlear implants, for the profoundly deaf. Cochlear implants are electronic systems that send sound-generated impulses to the brain to bypass a flaw in the inner ear.

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Symphonix Devices, Inc. Introduces the Vibrant Soundbridge

April 2001

Editor: Symphonix Devices, Inc. introduced their The Vibrant(r) Soundbridge (TM) device at the recent American Academy of Audiology (AAA) convention. The Soundbridge is an implantable middle ear hearing device (IMEHD) designed to treat moderate to severe sensorineural hearing loss. It provides yet another new treatment option for people with hearing loss.

Here are portions of their press release.

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The Vibrant(r) Soundbridge (TM) will be the subject of 10 presentations at the 13th Annual Convention of the American Academy of Audiology (AAA), taking place next week in San Diego, Calif., stated Kirk Davis, president and chief executive officer of Symphonix Devices, Inc. (Nasdaq: SMPX – news). The Vibrant Soundbridge is an implantable middle ear hearing device (IMEHD) designed to treat moderate to severe sensorineural hearing loss, the most common form of hearing impairment.

“The Vibrant Soundbridge offers audiologists a new treatment option for appropriate patients”, said Elizabeth Coughlin, M.S., a practicing audiologist and instructor for the course entitled `Incorporating the Vibrant Soundbridge Into Your Practice’. “The device expands our ability to better help some of our current patients, while also drawing in others who may not have considered using an assistive device previously. By doing so, it holds promise to positively affect people’s lives and our practices in meaningful ways.”

“Our initial outreach to audiologists has been met with a favorable response, so we are looking to the AAA as a prime venue for introducing the Vibrant Soundbridge to the greater audiology community,” said Davis. “This educational outreach marks the next milestone in our marketing strategy. In the first phase we focused on building a strong foundation of support from ear, nose and throat surgeons. Now we have a nationwide network of more than 35 surgical Centers of Excellence in place and are focusing on introducing the device to audiologists, who are the primary hearing healthcare-givers and a significant, trusted source of information for patients seeking treatment for their hearing loss.”

About Symphonix

Founded in 1994, Symphonix Devices, Inc. is a hearing technology company dedicated to developing a family of products to improve communication ability and quality of life for the millions of hearing-impaired individuals limited by current hearing solutions.

Symphonix’ Vibrant Soundbridge is a surgical implant designed to work with the natural structures of the middle ear to enhance hearing and communication ability for people with hearing impairment. The device can be implanted during a short, outpatient surgical procedure.