AudiologyOnline Phone: 800-753-2160


Oticon Work - September 2024

Next Generation Vibrant® Soundbridge™ Approved by the U.S. Food and Drug Administration

Share:

SAN JOSE, Calif. -- Symphonix Devices, Inc. (NASDAQ: SMPX) recently announced that the U.S. Food and Drug Administration (FDA) has approved the incorporation of a new digital signal processing (DSP) technology into the Vibrant® Soundbridge™. The advanced, eight-channel DSP technology was developed by Siemens Audiologische Technik GmbH and has been licensed to Symphonix as part of a technology agreement finalized in 1999. This newest digital Vibrant Soundbridge was affixed with the CE mark in mid-2000, which allowed commercial distribution of the device in Europe. The Vibrant Soundbridge is a semi-implantable hearing device designed to work with the natural structures of the middle ear to enhance hearing and communication ability for people with hearing impairment.

'By utilizing the Siemens DSP technology platform, Symphonix can offer hearing healthcare professionals greater flexibility in programming the Vibrant Soundbridge while also positioning the device for future upgrades,' said Kirk Davis, Symphonix' president and chief executive officer.

The Vibrant Soundbridge will now be programmed using Siemens' PC-based CONNEXX(TM) fitting software, the same software currently used by audiologists worldwide to program Siemens' hearing aids. 'Compatibility with this widely-used software should minimize training requirements for programming the Vibrant Soundbridge, thereby facilitating its adoption into everyday practice among the large domestic network of independent audiologists,' Davis said.

The DSP technology is housed in the externally-worn Audio Processor portion of the Vibrant Soundbridge, so current users will be able to update their system easily and without further surgery. 'The semi-implantable design of the Vibrant Soundbridge allows functional enhancements to be made by replacing the external component,' Davis said. 'This means that patients won't have to undergo additional surgery to benefit from these system improvements.'

About the Vibrant Soundbridge

The Vibrant Soundbridge is the first implantable middle ear hearing device (IMEHD) to be approved by the FDA. Consisting of two components, one internally implanted and the other externally worn, 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.

About Siemens Audiologische Technik GmbH

Siemens is one of the world's largest manufacturers of hearing instruments and related fitting software. For nearly 100 years the company has been researching hearing impairment and has been developing products that have set industry standards for the support and care of hearing impaired persons. More information about Siemens can be found at www.hearing.siemens.de.

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 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 September 30, 2000.

Symphonix and Vibrant are registered trademarks of Symphonix Devices, Inc. Soundbridge is a trademark of Symphonix Devices, Inc. CONNEXX is a trademark of Siemens Audiologische Technik GmbH.

Rexton Reach - November 2024

Our site uses cookies to improve your experience. By using our site, you agree to our Privacy Policy.