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CaptionCall - Connect - August 2023

Symphonix Devices, Inc. Receives FDA Panel's Approval Recommendation for the Vibrant® Soundbridge™

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SAN JOSE, Calif. - The Ear, Nose, and Throat Medical Devices
Advisory Panel of the Food and Drug Administration (FDA) unanimously
recommended that the Vibrant® Soundbridge™ be approved for use in the United States, announced Kirk Davis, president and chief executive officer (CEO) of Symphonix Devices, Inc. (NASDAQ: SMPX), the developer of the device. 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 panel's recommendation brings us one step closer to making the Vibrant
Soundbridge available to millions of hearing-impaired people across the
United States,' Mr. Davis stated. 'We are pleased that the panel reviewed
our extensive clinical data and reached the same conclusion we did - that
the Vibrant Soundbridge is a safe and effective treatment for people who
desire an alternative to acoustic hearing aids.'

The U.S. clinical trial of the Vibrant Soundbridge, which was conducted at
10 clinics and universities across the nation, demonstrated that the device
performs better than hearing aids in many environments. For example, the
investigation documented that patients implanted with the Vibrant
Soundbridge perceived a benefit from improved sound clarity, quality and
increased functional gain as compared to their hearing aids. The patients
reported significant benefit from and preference for the Vibrant
Soundbridge in a variety of listening situations such as outdoors, in
restaurants, and when listening to television and radio - significant
concerns for people affected by hearing loss. In addition, participants in
the clinical trial noted that the Vibrant Soundbridge was more comfortable
to wear. Importantly, the vast majority of Vibrant Soundbridge patients
experienced no change in their pre-surgery hearing ability.

'As one of the investigational sites in the clinical trial, we had a very
positive experience with the Vibrant Soundbridge,' said Thomas Balkany,
M.D., professor and chairman of the department of otolaryngology at the
University of Miami School of Medicine. 'The procedure to implant the
device is straightforward and well understood by practicing otologists. The
response from our patients has been very encouraging and we look forward to
be able to offer the treatment to a greater number of people.'

David Fabry, Ph.D., director of audiology at the Mayo Clinic, participated in the FDA panel review. 'The compiled data from all of the clinical trial sites is quite compelling,' Dr. Fabry said. 'The national trial results demonstrate that the vast majority of patients are more satisfied with the Vibrant Soundbridge, as compared to their hearing aids, in the key areas where hearing aids traditionally have limitations. Namely, effectiveness inbackground noise, overall fit and comfort, and the sound of their own voice. The Vibrant Soundbridge is a welcome addition to the options available for the hearing impaired.'

Symphonix is now awaiting final authorization from the FDA to begin
commercial operations in the United States. 'We are confident that we can
meet the conditions as outlined by the panel for approval,' Mr. Davis said.
'The company is committed to working with the agency to bring this
breakthrough technology to the public as soon as possible.'

About Symphonix

Founded in 1994, Symphonix Devices, Inc. is a hearing management company dedicated to developing a family of products to improve communication ability and quality of life for the millions of hearing-impaired
individuals who cannot benefit from current hearing technology. 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 risks that regulatory approvals will not be obtained in a timely manner, or at all, and that the Company's products will not achieve widespread market acceptance. 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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Vibrant is a registered trademark of Symphonix Devices, Inc. Soundbridge is
a trademark of Symphonix Devices, Inc.

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