SAN JOSE, Calif.-- Symphonix Devices, Inc. (Nasdaq: SMPX - News) --
"The data presented in the study suggests that not only is the Vibrant Soundbridge safe -- showing minimal impact on a patient's natural hearing -- it's also effective in improving a person's hearing to the degree they are highly satisfied with the device," Dr. Balkany said. "With this long-term study, and nearly 1,000 implants of the Symphonix amplification device, the Vibrant Soundbridge is becoming a more accepted medical option for the millions of people around the world who suffer from hearing loss."
Other key findings of the study, co-authored by Charles M. Luetje, M.D., of the Otologic Center of Kansas City, Missouri, showed that Vibrant Soundbridge patients achieved more functional gain in hearing -- by more than 10 to 15 decibels -- than they did with the use of conventional acoustic hearing aids. The study also showed that even after four years, patients implanted with the Vibrant Soundbridge continue to report very high levels of hearing and device satisfaction compared to that of conventional hearing aids.
"The findings presented in this important long-term patient study confirms the impressive results from the Vibrant Soundbridge clinical trial," said Bill Arthur, the newly appointed Symphonix chairman. "We now have the supportive data that proves the Vibrant Soundbridge is safe and effective over the long-term. This is the type of data private insurance companies want to see in order to provide coverage for a medical device and procedure. And based on my experience, we should see more positive coverage decisions by private health insurers."
In the study, researchers followed the first 100 U.S. patients implanted with the Vibrant Soundbridge since 1997. They evaluated the patients at 3, 12, 24, 36 and 48 month intervals post device activation, and looked for any loss in residual hearing, changes in tympanometry (ear drum compliance), as well as any changes in any functional gain. Researchers also evaluated the benefit patients reported over time with the Vibrant Soundbridge implant compared to that of traditional acoustic hearing aids.
The Vibrant Soundbridge represents a new approach to hearing improvement -- the implantable middle ear hearing device (IMEHD). Unlike conventional acoustic hearing aids, which increase the volume of sound that goes to the eardrum, the Vibrant Soundbridge bypasses the ear canal and eardrum by directly vibrating the small bones in the middle ear. Because of its design, no portion of the device is placed in the ear canal itself. The Vibrant Soundbridge has been approved by the FDA as a safe and effective treatment option for adults with moderate to severe sensoneural hearing loss who desire an alternative to acoustic hearing aids. Of the approximate 28 million Americans who suffer from hearing loss, 60 percent have moderate to severe hearing loss.
Individuals with moderate to severe sensoneural hearing loss who are interested in an alternative to hearing aids, can obtain more information about the Vibrant Soundbridge middle ear implant by calling Symphonix Devices, Inc. at 1-800-833-7733, or by visiting the Symphonix Web site at www.symphonix.com.
About Symphonix Devices, Inc.
Founded in 1994, Symphonix® Devices Inc. is a hearing technology company dedicated to providing a family of products to improve communication ability and quality of life for the millions of hearing-impaired people 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. More information about Symphonix can be found at www.symphonix.com or by calling 800-833-7733.
NOTE: Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc. Soundbridge is a trademark of Symphonix Devices Inc.
Statements made in the press release regarding the future performance of our business are "forward-looking statements" and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made. Such risks and uncertainties include, but are not limited to, the Company's products failing to achieve widespread market acceptance. Further information on potential factors that could affect the Company's financial results is included in the Company's Form 10-Q for the quarter ending March 2002, and Form 10-K for the 2001 fiscal year filed with the Securities and Exchange Commission.
For more information:
Media Contact -
Geraldine Floresca
Neale-May & Partners
+1-415-646-0055, ext. 501
gfloresca@nealemay.com
Investor Relations Contact -
Terry Griffin
CFO
Symphonix Devices Inc.
+1-408-232-0710
Long Term Study Confirms Symphonix® Middle Ear Implant Safe and Effective
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