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.