Study Results Indicate the Implantable Middle Ear Hearing Device is Better Alternative to Traditional Acoustic Hearing Aids
SAN JOSE, Calif. -- Symphonix® Devices, Inc. (NASDAQ: SMPX) announced the acceptance of a pivotal paper, "Phase III Clinical Trial Results with the Vibrant® Soundbridge™ Implantable Middle Ear Hearing Device --- A Prospective Controlled Multi-Center Study," for publication in the February issue of The Otolaryngology Head and Neck Surgery (O-HNS). The paper, authored by Charles M. Luetje, M.D., president and founder of the Otologic Center Inc. (Kansas, Mo.), details clinical findings that indicate the Vibrant® Soundbridge™ is the superior alternative to traditional hearing aids, improving quality and clarity of sound. Results of this study supported the FDA's decision in September 2000 to approve the Vibrant Soundbridge as a safe and effective treatment for those with moderate to severe sensorineural hearing loss.
To be considered for publication in the O-HNS Journal, papers must show a strong study design that accurately identifies etiologies, evaluates diagnostic strategies, and distinguishes among treatment options and outcomes.
"Clearly the O-HNS Journal has recognized the importance of this novel procedure and wishes to share it with its readers who looking for the best treatment available for hearing loss," said Kirk Davis, president and chief executive officer of Symphonix. "This study offers another validation that the Vibrant Soundbridge is a preferred alternative for
those with moderate to severe sensorineural hearing loss."
Symphonix based its clinical trial on rigorous, prospective, single-subject and repeated measures design, ensuring validity of the data by minimizing potential patient bias. The trial was conducted at 10 centers across the United States, including the Otologic Center Inc., Kansas City, Mo.; University of Miami; and the House Ear Institute, Los Angeles. In all, 53 subjects between the ages of 28 and 86 and were studied, each an experienced hearing aid user who was actively seeking a superior alternative to traditional acoustic hearing aids.
Trial subjects were initially evaluated using their appropriately fitted conventional hearing aids, then each subject was implanted with the Vibrant Soundbridge and evaluated three months after. Findings compared the subjects' experiences with the conventional hearing aid to that of the Vibrant Soundbridge.
Results demonstrated that 94 percent of subjects realized substantial hearing improvements with the Vibrant Soundbridge. Other key findings regarding the Vibrant Soundbridge advantages include:
-Improved sound quality and clarity
-Statistically significant performance and preference
-Virtually eliminating feedback
-Clinically unchanged residual hearing
"This study validates that the Vibrant Soundbridge improves sound quality for patients with moderate to severe sensorineural hearing loss better than anything else on the market today," said Dr. Luetje. "Now doctors have a superior treatment option to recommend to their patients who are looking for alternatives to the traditional method."
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 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.
Further information on potential factors that could affect the Company's financial results is included in the Company's Form 10-K for the 2000 fiscal year and Form 10-Q for the quarter ended December 31, 2001 filed with the Securities and Exchange Commission.
Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc. Soundbridge is a trademark of Symphonix Devices, Inc.
Pivotal Paper on Symphonix' Vibrant Soundbridge to be Published in Leading Otolaryngology Journal
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