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The Earsmate hearing aid amplifiers and OTC Hearing aid are approved by a series quality certificates (FDA/CE/ROHS/FCC, MSDS,UL and Free Sales Certificate of CFS etc ) to cooperate with the USA, Japan, Russia, Asia, Middle East, Africa, South America, Europe area of more than 78 countries and area. To enhance our company quality and service, we act by the ISO management system and have the ISO13485 medical certificate.