FOR IMMEDIATE RELEASE:
Toronto, Ontario, Canada, February 4, 2005 - Vivosonic Inc., a Toronto-based medical device developer, is pleased to announce U.S. Food and Drug Administration (FDA) approval for Integrity™, the world's first and only wireless objective hearing-assessment system.
With FDA approval, the Integrity™ is now available to the U.S. market. Integrity™ expands the company’s objective hearing-assessment product range from Otoacoustic Emissions (OAEs) into Auditory Evoked Potentials (AEPs): Auditory Brainstem Response and Auditory Steady State Response.
”I am very proud of this and think it is a major milestone in diagnostic Audiology equipment”, said Dr. Yuri Sokolov, Vivosonic president & CEO. “The Integrity™ incorporates cutting-edge technologies – from the Amplitrode™, the novel miniature in-situ AEP amplifier, to wireless communications and advanced digital signal-processing techniques.”
"Wireless technology represents a major breakthrough in AEP testing," adds Sid Tannenbaum, Product Marketing Manager at Vivosonic. "The freedom of mobility will be especially beneficial for those practitioners who treat infants referred from newborn hearing screening programs, as the infant can now be carried and comforted during the test, as well as to those monitoring hearing in Operating Rooms. We are delighted to offer the Integrity™ to the U.S. market."
With FDA approval obtained for the Integrity™, the world’s first wireless objective hearing-assessment system, Vivosonic Inc. can now expand its product offering to the U.S. market to include Auditory Evoked Potentials as well as Otoacoustic Emissions. Product can be ordered immediately for delivery in April 2005.
