Die Vibrant Soundbridge ist das erste chirurgische Implantat, das für die Behandlung eines geringen bis schweren sensorineuralen Hörverlustes (d. h. einer Innenohrschwerhörigkeit) zur Verfügung steht. Die von Symphonix Devices entwickelte Soundbridge (Schallbrücke) funktioniert im Mittelohr. Das Gerät simuliert und verstärkt die natürlichen Bewegungen der vibrierenden Gehörknöchelchen und verbessert dadurch die Qualität der Tonsignale, die das Innenohr und von dort aus das Gehirn erreichen.
Bei der Verwendung der Soundbridge bleibt der Gehörgang offen, es treten weder Okklusionen noch Druckempfindungen auf, und die örtliche Bestimmung des Schalls wird verbessert. Akustische Rückkopplung, über die sich Hörgeräteträger häufig beschweren, tritt nicht auf. Die Soundbridge ist so konzipiert, daß sie die Sprachgenauigkeit (natürlicher Ton) und die Sprachverständlichkeit verbessert. Die bei sichtbaren Hörgeräten auftretenden ästhetischen Probleme werden vermieden, da das Haar des Trägers in der Regel den äußerlich getragenen Audio Processor verdeckt. Diese Eigenschaften bewirken für den Hörbehinderten Verbesserungen in psychologischer wie in beruflicher Hinsicht, was eine höhere Lebensqualität zur Folge hat.
Die Vibrant Soundbridge besteht aus zwei Teilen: 1) dem Implantat, das als Vibrating Ossicular Prosthesis (VORP) bezeichnet wird, und 2) dem äußerlich getragenen Audio Processor. Das VORP wird durch einen chirurgischen Eingriff implantiert. Es besteht aus dem Floating Mass Transducer (FMT), einem Leitungskabel und einem internen Empfänger. Der FMT wird am Amboß im Ohr des Patienten befestigt.
Nach der Genesung des Patienten von dem chirurgischen Eingriff wird der Audio Processor an dessen Kopf angebracht. Er enthält ein Mikrophon, programmierbare Verarbeitungselektronik, ein Übertragungssystem und eine Batterie für die Energieversorgung. Der Audio Processor wird mit einem Magneten hinter dem Ohr des Patienten festgehalten. Der Audio Processor wird durch einen Audiologen oder sonstiges zu diesem Zweck ausgebildetes Personal angepaßt, damit seine Wirkleistungsabgabe den FMT richtig treibt.
U.S. Food and Drug Administration Approves the Vibrant Soundbridge to Treat Sensorineural Hearing Loss
Millions of Americans to Benefit from New Technology
SAN JOSE, Calif. – August 31, 2000 – The Food and Drug Administration (FDA) has approved the Vibrant® SoundbridgeTM for use in the United States, announced Kirk Davis, president and chief executive officer of Symphonix Devices, Inc. (NASDAQ: SMPX), the developer of the device. The Vibrant Soundbridge is an Implantable Middle Ear Hearing Device (IMEHD) intended to treat moderate to severe sensorineural hearing loss, the most common form of hearing impairment.
“We believe our strong clinical trial data and the unanimous recommendation for approval from the FDA’s Ear, Nose and Throat Medical Devices Panel helped the agency to conclude that the Vibrant Soundbridge is a safe and effective treatment for people who desire an alternative to acoustic hearing aids,” said Davis. “The approval of this revolutionary device represents the first new treatment in more than a century for the millions of adults with moderate to severe sensorineural hearing loss.”
Very different from a hearing aid, the Vibrant Soundbridge utilizes direct-drive technology to stimulate the tiny bones in the middle ear, enhancing the natural hearing process. Its unique design addresses the problems commonly associated with acoustic hearing aids such as poor sound quality, feedback, background noise and discomfort. Implantation of the device is completed via an outpatient surgical procedure that lasts one-and-a-half to two hours. Patients usually can return to normal activities within a few days.
Hearing loss affects approximately 28 million people in the United States, the vast majority of whom suffer from sensorineural hearing loss. It occurs when the hair cells or nerves in the inner ear become damaged, often because of exposure to loud sounds, genetic factors or the natural aging process. It is a communication disorder that can impact an individual’s work performance, social interactions, and general quality of life.
“Current options for the hearing-impaired are less than adequate,” Davis said. “Only 20 percent of the hearing-impaired population own hearing aids, and many of these hearing aid users are looking for a better alternative. Symphonix designed the Vibrant Soundbridge to allow more people to benefit from better hearing.”
“I’ve had great success with the Vibrant Soundbridge,” said Charles Luetje, M.D., of the Otologic Center in Kansas City, Missouri and one of the principal investigators in the Vibrant Soundbridge clinical trial. “This is an important new solution we can offer in our practice to treat hearing loss. My Soundbridge patients and their families have expressed great pleasure with their improved hearing ability. I look forward to bringing this technology to other hearing-impaired people seeking ways to be more engaged in the world around them.”
The U.S. clinical trial of the Vibrant Soundbridge was conducted at 10 clinics and universities across the nation. Patients who participated in the clinical trial of the Vibrant Soundbridge reported improved sound clarity and quality, better overall fit and comfort, and perceived benefit in many listening situations as compared to their own hearing aids.
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. Worldwide, more than 375 patients have been implanted with the Vibrant Soundbridge. More information about Symphonix can be found at http://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, 2000.
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