What is the difference between an FDA Registered hearing aid and an FDA Approved hearing aid?
Air conduction hearing aids, such as the MDHearingAid PRO and LUX are Class I medical devices. Owners or operators of businesses that produce and distribute Class I medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration.
FDA approval means that the FDA has decided the benefits of the approved item outweigh the potential risks for the item's planned use. This term is more commonly applied to drugs and medical procedures than Class I medical devices. Only FDA Registered hearing aids meet or exceed federal standards for Class I medical devices.
A PSAP, like the ones found on Amazon, eBay, in drug stores and seen on late night TV may make everything equally loud and not have the frequency shaping needed for most hearing loss. In contrast, hearing aids are Class I medical devices, subject to a higher level of federal regulation, and programmed with different frequency responses to fit a wide range of hearing loss.
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