Company Also Successfully Completes FDA Quality System Regulation Audit
SAN JOSE, Calif. - Symphonix Devices, Inc. (NASDAQ: SMPX)
has been notified that the U.S. Food and Drug Administration's (FDA) Ear,
Nose, and Throat Devices Advisory Panel will review the company's pre-market approval (PMA) application for the Vibrant® Soundbridge™ on July 20, 2000. The Vibrant Soundbridge is a semi-implantable hearing device designed to treat moderate to severe sensorineural hearing loss, the most common form of hearing impairment.
''We are pleased to have reached this key milestone,'' said Kirk Davis,
president and CEO of the San Jose, Calif.-based developer of the device.
''We look forward to reporting the results of our Phase III clinical trial
to the Advisory Panel. Our data appears to indicate that the Vibrant
Soundbridge system meets or exceeds all of the originally intended claims
for the device.''
As a participant in the FDA's Modular PMA process, Symphonix has been
working closely with the FDA on the review of the marketing application. An
important element of the review was an audit of the Company's manufacturing
facility and quality systems to ensure that the Vibrant Soundbridge can be
produced in conformance with regulatory requirements. The FDA audited
Symphonix using the Quality System Inspection Technique (QSIT), an approach introduced by the agency in 1999. The audit was successfully completed with no observations.
''We found the QSIT audit to be a comprehensive and efficient mechanism to
assess our quality system,'' Davis commented. ''The technique parallels that used by international regulators and, therefore, lends itself to facilities and systems that are ISO compliant.'' Symphonix' facilities were recently re-certified to ISO 9001, EN 46001, and ISO 13485 by its Notified Body, TUV Product Service.
About Symphonix
Founded in 1994, Symphonix Devices, Inc. is a hearing technology company
dedicated to developing a family of products that will 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 350 patients have been implanted with Vibrant Soundbridges. More information about Symphonix can be found at https://www.symphonix.com.
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 risk that FDA approval of the Company's PMA will not be obtained on a timely basis or at all, the risk that, if approved by the FDA, the claims allowed for the Vibrant Soundbridge will be narrower than those proposed by the Company, and the risk that, if approved by the FDA, the Vibrant Soundbridge will not receive widespread market acceptance in the U.S. For further information, refer to the risk factors described in the Company's Form 10Q for the quarter ended March 31, 2000.
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Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc.
Soundbridge is a trademark of Symphonix Devices, Inc.
Symphonix Devices, Inc. Notified of FDA Advisory Panel Date for Vibrant® Soundbridge™
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