Landmark Study Presented at the American Academy of Otolaryngology Annual Meeting
American Academy of Otolaryngologists Annual Meeting -- DENVER -- Results of a study on the long-term effects of the Vibrant® Soundbridge™ were presented today at the American Academy of Otolaryngology (AAO) Annual Meeting and OTO EXPO confirming that the device is safe and effective for long-term use. The Vibrant Soundbridge, developed by Symphonix Devices, Inc. (NASDAQ: SMPX), is the first implantable middle ear hearing device (IMEHD) to be approved by the FDA and is designed to treat the most common form of hearing impairment, moderate to severe sensorineural hearing loss. The performance of the Vibrant Soundbridge was evaluated in the first 100 patients, each of whom chose the device after having prior experience with traditional hearing aids. All subjects had been implanted with the device for at least one year, with some representing continuous usage for up to three years.
Dr. David Kelsall, an otologist with the Denver Ear Associates, presented the findings of the study, revealing that patients implanted with the Vibrant Soundbridge for twelve months or more continued to report improved hearing performance with minimal background noise interference, better overall fit and comfort and excellent overall sound quality.
'This study indicates continued high levels of patient satisfaction with the Vibrant Soundbridge,' said Dr. Kelsall. 'Performance of the device's 'direct drive system', which utilizes an open ear canal design, continues to mark major improvement over the problems associated with traditional acoustic hearing aids. This represents a significant finding for the many hearing impaired who continue to be dissatisfied with or choose not to use conventional treatment methods. The results to date show that baseline hearing has remained unchanged, and patients are continuing to experience improvements in all aspects of hearing ability a year or more after implantation.'
In addition to presenting a paper on the long-term effects of the Vibrant Soundbridge, Dr. Kelsall conducted a satellite workshop on the device on Friday, Sept. 7 for surgeons attending the AAO annual meeting. The Symphonix-sponsored workshop, which took place at Swedish Medical Center in Denver, introduced the attendees to the Vibrant Soundbridge implantation technique, which combines elements of common ear surgeries. The hands-on workshop was held in a wet lab setting to allow surgeons to practice the procedure.
'Positive reviews of the Vibrant Soundbridge technology from both hearing health professionals and patients who have been implanted provided an interest for me in learning more about the device and its related procedure,' stated James Andrews, M.D., an otologist with Pacific Head and Neck in Los Angeles, Calif., and Clinical Professor of Surgery at the University of California Los Angeles. 'Symphonix' workshop gave me helpful experience with the Vibrant Soundbridge, demonstrating that the surgery is straight-forward.'
Symphonix' other AAO meeting activity includes unveiling a new selection of colors for the Vibrant Soundbridge Audio Processor, the external component of the device. Providing customers with greater cosmetic options, the new colors were incorporated to allow the patient to more closely match his or her hair. Symphonix will be showing the new Audio Processors at booth ##1643, where representatives of the company will also be on hand to discuss the Vibrant Soundbridge, its underlying technology and findings related to its long-term use.
'The AAO is a great backdrop for announcing the Vibrant Soundbridge's long-term viability as an alternative to the traditional hearing aid,' said Davis. 'The recent study shows that the device's direct drive technology continues to perform well with minimal risk or complications, even in patients who were implanted up to three years ago. This news, combined with our workshop outreach, provides a chance for Symphonix to introduce the Vibrant Soundbridge to more professionals in the hearing health industry, ultimately enhancing our referral network and helping us provide a safe, effective, long-term solution to those with moderate to severe sensorineural 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. More information about Symphonix can be found at https://www.symphonix.com, or by calling 1-800-833-7733.
Except for historical information, statements made in this press release 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. For further information, refer to the risk factors described in the Company's Form 10Q for the quarter ended June 30, 2001.
Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc. Soundbridge is a trademark of Symphonix Devices, Inc.
Symphonix-Sponsored Clinical Study Reports Long-Term Benefits Of The Vibrant Soundbridge For The Hearing Impaired
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