Air conduction hearing aids, such as MDHearing devices, 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.
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 personal sound amplification product (PSAP), like the ones found on Amazon, eBay, and in drug stores, may make everything equally loud and not have the frequency shaping needed for most hearing loss. In contrast, hearing aids are subject to a higher level of federal regulation, and programmed with different frequency responses to fit a wide range of hearing loss.
Over the Counter (OTC) hearing aids are hearing aids designed to treat mild to moderate hearing loss and be fit without the help of a hearing healthcare professional. They will be regulated as Medical Devices by the FDA. However, the final guidance on OTC hearing aids has not been established and there are no products that can be legally marketed as OTC hearing aids.
Over the Counter (OTC) hearing aids are hearing aids designed to treat mild to moderate hearing loss and be fit without the help of a hearing healthcare professional. They will be regulated as Medical Devices by the FDA. However, the final guidance on OTC hearing aids has not been established and there are no products that can be legally marketed as OTC hearing aids.