Vivosonic Approved to Sell Integrity V500 System for Hearing Diagnostic Testing in China
Vivosonic has received regulatory approval from the State Food and Drug Administration (SFDA) of the People’s Republic of China to sell Integrity V500 System for hearing diagnostic testing. Products will be sold through KAM Healthcare Group.
KAM Healthcare Group
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May 28, 2012 - PRLog -- Toronto, ON, May, 2012 - Vivosonic Inc. has received regulatory approval from the State Food and Drug Administration (SFDA) of the People’s Republic of China to sell IntegrityTM V500 System for hearing diagnostic testing in China. It is anticipated that approval for Vivosonic’s AurixTM Newborn Hearing Screening System is soon to follow. Both IntegrityTM and AurixTM products will be sold through KAM Healthcare Group (http://www.kamhealthcare.com/) which provides advanced audiological equipment, hearing instruments, and hearing services in Hong Kong, Macau, China, and other countries in the Asia Pacific region. Over the next few months, KAM Healthcare Group will showcase Vivosonic products at several important seminars across China attended by prominent guests and speakers in audiology.
“Certification to sell our products in China is an important achievement,” says Mike Schnekenburger, President and CEO of Vivosonic. “We are grateful to Mr. KAM Ping Kay’s team at KAM Healthcare Group for all of their work on the certification process. They have worked closely with us to ensure that our products meet China’s strict regulatory requirements. IntegrityTM and AurixTM were first introduced to China two years ago at several conferences and workshops. Since then, interest in our advanced technologies has been growing in anticipation of the SFDA approval. Now that the door is open, we are eager to make a valuable contribution to hearing healthcare in China.”
A new 40 Hz ERP (event related potential) test modality has been developed especially for audiology practices in China. This measurement technique, often used to obtain hearing thresholds levels at low frequencies in young “active” children, will be available on the Vivosonic Integrity V500 System. Clinical evidence indicates that 40 Hz ERP may be a technique that can augment traditional ABR threshold testing at low frequencies. The 40 Hz ERP modality will have the advantage of Integrity’s sophisticated filtering techniques that can minimize the effects of myogenic noise. In addition, wireless capabilities will enable the audiologist to collect recordings while a child plays quietly, untethered to the equipment. View video at http://www.youtube.com/watch?v=wQ_LeDh25kI
Vivosonic Inc. (http://www.vivosonic.com/) manufactures advanced audiological equipment for hearing diagnostic testing and newborn hearing screening. The spirit of innovation, research and engineering is at the heart of every Vivosonic product. Patented award-winning technologies meet the clinical challenges of today’s hearing healthcare professionals, and improve patient care and safety. Headquartered in Toronto, Canada, the company is ISO 13485 certified with products marketed and sold globally through a distributor network in over 35 countries.
The Vivosonic IntegrityTM System for hearing diagnostic testing provides non-sedated ABR, DPOAE, TEOAE, non-invasive ECochG, fully automated ASSR, and 40 Hz ERP. This advanced technology helps to minimize the risks of sedation and anaesthesia, enables testing of difficult-to-test cases, and is portable and easy-to-use. AurixTM Newborn Hearing Screening System is the most advanced automated brainstem response (AABR) system available. It enables recording of ABR when infants are awake and stirring, and is specifically designed to provide reliable results in Neonatal Intensive Care Units (NICU) and other difficult-to-test environments.