Vivosonic’s IntegrityTM V500 System is now available in Japan. The certification to sell the product was recently received from Japan’s Ministry of Health, Labour and Welfare, the equivalent of the US FDA.
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| Japan’s Rion Co Ltd team with the Integrity V500 System |
The product will be sold exclusively through Rion Co. Ltd, which provides advanced audiological equipment, hearing instruments, medical equipment, sound and vibration measuring instruments, and equipment for measuring airborne and liquid-borne particles.
“Our partner, Rion, has been instrumental in our efforts to obtain regulatory approval in Japan. It is through their expertise and dedication that we were able to successfully complete the process in an expeditious manner,” says Mike Schnekenburger, president and CEO of Vivosonic. “Product quality is a foremost consideration in Japan. We are proud of Vivosonic’s commitment to continuous quality improvement and the ability of our IntegrityTM system to meet the country’s high standards of quality in hearing diagnostic testing.”
Hearing healthcare professionals in Japan now have the opportunity to benefit from Vivosonic’s filtering techniques, which enable quality recordings of auditory evoked potentials while a child plays quietly; patented Amplitrode®, which minimizes the effects of electromagnetic interference in the NICU, OR, and other harsh environments; and wireless capabilities, which provide clinical convenience.
View demonstration video below or on Youtube.
SOURCE:Vivosonic
