AudiologyOnline Phone: 800-753-2160


Signia Active IX - December 2024

Symphonix Devices, Inc. Receives CE Mark for Next Generation Vibrant® Soundbridge™

Share:

New System Incorporates Advanced Technology from Siemens Audiologische
Technik GmbH


SAN JOSE, Calif. - Symphonix Devices, Inc. (NASDAQ: SMPX), a San Jose, Calif.-based hearing technology company, has received authorization to affix the CE Mark to the next generation of its Vibrant® Soundbridge™ system, announced Kirk Davis, president and chief executive officer of Symphonix. 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.

The next generation system integrates advanced, eight-channel digital
signal processing technology (DSP) technology from Siemens Audiologische
Technik GmbH, a worldwide leader in hearing healthcare. This technology
integration is the first joint project resulting from a multi-year
technology and European distribution agreement between Symphonix andSiemens.

''Our partnership with Siemens enables us to effectively leverage their
gold-standard technology and existing relationships with hearing healthcare
professionals to continue to grow our business,'' Davis said.

Since the DSP technology is housed in the external portion of the device,
current Vibrant Soundbridge patients can easily upgrade their system. ''The
design of the Vibrant Soundbridge enables us to provide greater
functionality through the external component, so patients don't have to
face another surgery to gain the benefits of the these, and future, system improvements,'' Davis said.

Additionally, the Vibrant Soundbridge will now utilize Siemens' PC-based
CONNEXX™ fitting software, the same software currently used by
audiologists worldwide to program Siemens' hearing aids. Benefits of using
CONNEXX software include the ability to better customize the Vibrant Soundbridge to an individual's hearing loss.

The Vibrant Soundbridge has been commercially available in the European
Union (EU) since March 1998, with more than 350 people worldwide now using the device. Since that time, Symphonix has received four CE Marks for the Vibrant Soundbridge. The CE Mark permits commercialization of the device in the EU and demonstrates that the device surpasses the essential performance and safety requirements, as described in the applicable EU directives and standards. This designation is also recognized by countries outside the EU, such as Norway and Switzerland.

About the Vibrant Soundbridge

The 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 patented, proprietary
device, which is comprised of internal and external components, works by
directly stimulating the tiny bones in the middle ear, mimicking the
frequency response of the human ear to sound.

This ''direct drive technology'' leaves the ear canal open and ear drum
undisturbed, alleviating problems commonly associated with hearing aids,
such as feedback, occlusion, unnatural sound quality, discomfort, ongoing
maintenance and social stigma. The device can be implanted during a short,
outpatient surgical procedure.

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. More information about Symphonix can be found at 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 risks that regulatory approvals will not be obtained in a timely manner, or at all, and that the Company's products will not achieve wideespread market acceptance. For further information, refer to the risk
factors described in the Company's Form 10Q for the quarter ended March 31,2000.
_________

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.

Phonak Infinio - December 2024

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