If you are a US seller/distributor, you may have this confusion, what is the difference between a hearing aid and an amplifier? Why some of my competitors claim that their products are hearing aids, and others are amplifiers? Are the import tariff rates the same?
If you have such confusion, please review the table below to illustrate the same and different points between hearing aids and PSAPs.
(personal sound amplification products)
|Definition||A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing.||A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in certain environments, such as for hunting or other recreational activities.|
|Intended Usage||Compensate hearing loss.||Not compensate hearing loss, not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, but amplify sounds in some environments.|
|Classification||Medical device||Electronic product|
|Similarity||They are both wearable, and some of their technology and function is similar. Both could improve our ability to hear sound.|
|Restriction from FDA||There are many strict requirements for hearing aids as medical devices.||PSAPs are not devices as defined in the FDA Act.|
As such, there is no regulatory classification, product code, or definition for these products.
Furthermore, there are no requirements for registration of manufacturers or listing of these products with FDA.
|FDA Establishment Registration||YES||NO|
|FDA Device Listing||YES||NO|
|US Import Tariff||Free||about 1.2%|
In short, hearing aids are medical devices. The FDA has strict regulations on hearing aids, including packaging labeling, marketing, device registration, etc. The amplifier does not compensate for hearing loss and it is an electronic product.
If you worked in other industries before and you are not sure if you should sell hearing aids or amplifiers now, you are welcome to communicate with us. We will share more inside info with you.
Reference:Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff