All the products sold on Neosonictech.com are not hearing aids. They are Personal Sound Amplifier Product (PSAP) as defined by the United States FDA.

PSAPs are not intended to amplify speech or environmental sounds for individuals with impaired hearing or to compensate for hearing impairment.

Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the body, they are not devices as defined in the Food, Drug and Cosmetic Act.

As such, there is no regulatory classification, product code, or definition of these products.