FOR IMMEDIATE RELEASE:
Toronto, Ontario, Canada, February 1, 2006 - Vivosonic Inc., a Toronto-based medical device developer, has begun shipping Integrity™, the world’s first and only Bluetooth(R) wireless Auditory Brainstem Response (ABR) Instrument. Integrity enables practical ABR testing by dramatically clearing the responses from physiological artifacts and electro-magnetic interferences, thus extending ABR to testing non-relaxed patients in non-shielded rooms. Small and highly portable, the Integrity is ideal for testing patients of all ages – in hospitals, private clinics, and even at the patient’s home.
Recently, Vivosonic introduced Integrity™ to the world markets at Medica 2005, the world’s largest annual medical trade fair in Düsseldorf, Germany, and Arab Health 2006 medical fair in Dubai, UAE. We will be presenting Integrity at the 2006 American Academy of Audiology convention in Minneapolis, MN, the world’s largest Audiology annual meeting.
“I am very excited that we have started shipping the long-awaited Integrity ABR system,” says Mr. Ed Goss, Director of Operations and Institutional Sales. “We ensure the very highest product quality by manufacturing Integrity on our own premises in Toronto, ON through our Quality System certified to ISO 13485:2003 standard for medical devices. Integrity is cleared by the Food and Drug Agency (FDA) and Federal Communications Commission (FCC) and licensed by Health Canada. Certain technical difficulties deferred the shipments, which is why we have a significant backlog of orders, but we are confident we will clear it within the next two months and anticipate meeting the demand for the product thereafter.”
“Integrity represents a huge technological leap forward in the Audiology industry,“ says Isaac Kurtz, M.H.Sc., P.Eng., Vivosonic's Director of Engineering and Research. “It solves the two fundamental problems clinicians experience in ABR testing – environmental electro-magnetic interferences and patients’ muscular motion artifacts.”
“Auditory Brainstem Response (ABR) is the first of four near-term objective hearing assessment modules on Integrity platform,” says Dr. Yuri Sokolov, Ph.D., President and CEO. “Additional modules, which will be added in the near future, include Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE), and Auditory Steady State Response (ASSR) composing a most innovative and practical auditory electrophysiological system.”
About Objective Hearing Assessment
While traditional hearing tests typically involve placing a patient in
an audiometric sound booth and obtaining his/her subjective responses
to pure tones or speech stimuli, audiologist 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 (OAE), which measure the function of the Cochlea, and Auditory Evoked Potentials (AEP), which measure the ability of the Auditory Nerve and brain to process auditory signals. AEP tests typically include Auditory Brainstem Response (ABR) and more recently Auditory Steady State Response (ASSR) for topical diagnosis and objective assessment of hearing thresholds, the latter being fundamental for further hearing aid fitting.
