Hearing aids belong to several classes of medical devices

Class II medical devices. Hearing aids belong to the medical device products, in the medical device classification directory belongs to the second class of medical devices, regulated by the State Food and Drug Administration, hearing aid technology in the continuous updating of the iteration, the appearance of small and exquisite hearing aids on the quality of the components of the requirements are very high, and at the same time require a very advanced manufacturing process. Medical device ring refers to instruments, equipment, appliances, materials or other items used in the human body, alone or in combination, including the required software. China divides medical devices into three categories, the first category is sufficient to ensure its safety and effectiveness through routine management of medical devices, such as ordinary surgical knives and scissors, dressings and so on. The second category of medical devices whose safety and effectiveness should be controlled, such as medical suture needles. The third category of potential danger to the human body, its safety and effectiveness must be strictly controlled medical devices.