//What you need to know for selling hearing aids or amplifiers in the USA

What you need to know for selling hearing aids or amplifiers in the USA

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.

Hearing aid V.S. PSAP

Hearing aid V.S. PSAP

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Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff

Other related posts you could read:

What We Learn From FDA’s Over-the-Counter Hearing Aid Letter as A Hearing Aid Distributor

FDA allows marketing of first self-fitting hearing aid controlled by the user

By |2019-10-16T07:06:06+00:00September 10th, 2019|Buyer Guidance|0 Comments

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