Vivosonic has received regulatory approval from China’s State Food and Drug Administration (SFDA) to sell the Integrity V500 newborn hearing screening system (pictured). The company also expects that its Aurix screening system will be approved in the near future.
Both the Integrity and Aurix products will be sold through KAM Healthcare Group, which provides advanced audiological equipment, hearing instruments, and hearing services in Hong Kong, Macau, China, and other countries in the Asia Pacific region.
KAM Healthcare Group will represent Vivosonic products at several important audiology-related seminars across China over the coming months.
"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."
Integrity and Aurix were first introduced to China 2 years ago at several conferences and workshops.
Vivosonic also reported in its press release that a new 40 Hz ERP (event related potential) test modality has been developed for Integrity especially for audiology practices in China. The measurement technique is often used to obtain hearing thresholds levels at low frequencies in young "active" children.
The 40 Hz ERP modality will also include Integrity’s proprietary 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.