Worlds First Wireless Objective Hearing-Assessment System Receives FDA Approval
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 companys objective hearing-assessment product range from Otoacoustic Emissions (OAEs) into Auditory Evoked Potentials (AEPs): Auditory Brainstem Response and Auditory Steady State Response.
Toronto, Ontario, Canada, (PRWEB) February 7, 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 companys 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 worlds 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.
About Objective Hearing Assessment:
While traditional hearing tests typically involve placing a patient in an audiometric sound booth and recording his/her subjective responses to pure tones or speech stimuli, audiologists and physicians often need more objective measurements, either because the patient cannot respond, e.g. an infant, or because traditional tests cannot provide sufficient data for accurate diagnosis.
Objective hearing assessment generally includes Otoacoustic Emissions (OAEs), which measure the function of the inner ear, and Auditory Evoked Potentials (AEPs), which measures the ability of the brain to process auditory signals. AEP tests typically include Auditory Brainstem Response (ABR) and more recently Auditory Steady State Response (ASSR).
About Integrity:
Integrity features three major world-first innovations:
1. Amplitrode, a novel electrode-amplifier which reduces frustrating noises by amplifying electrical potentials in-situ, directly on the ground electrode.
2. VivoLink, a wireless Bluetooth® interface between the signal-recording unit and the computer.
3. Vivography, an advanced digital signal-processing technique which reduces the patients muscular-motion artifacts and speeds up testing.
Together, these innovations allow the Integrity to largely reduce or eliminate many of the frustrations that hamper an Audiologist's ability to perform Auditory Evoked Potential testing, the foremost being electro-magnetic and physiologic noises, while providing both the Audiologist and the patient with an unprecedented level of mobility. Integrity is available in any combination of DPOAE, TEOAE, ABR, ASSR, for auditory diagnostics in infants through seniors.
About Vivosonic:
Vivosonic was founded in Toronto, ON, Canada in 1999 as a result of prior research at the University of Toronto. We are a developer and manufacturer of novel medical devices. Our vision is to deliver health-care professionals diagnostic solutions that improve their clinical efficiency: advanced, yet user-friendly instruments based on cutting-edge technologies.
For more information, please contact:
Sidney Tannenbaum, MBA
Product Marketing Manager
Vivosonic, Inc.
56 Aberfoyle Cr., Suite 620
Toronto, ON Canada M8X 2W4
Toll-free (U.S. & Canada): 1 877 255 7685, ext. 24
Phone: +1 416 231 9997
Fax: +1 416 231 2289
Email: sales@vivosonic.com
URL: www.vivosonic.com
Forward-looking statements are based on assumptions made by and information available to Vivosonic Inc.
Integrity, Amplitrode, VivoLink, and Vivography are trademarks of Vivosonic Inc.
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