Hearing Aids vs. Personal Sound Amplification Products

Hearing Aids vs. Personal Sound Amplification Products

You may have seen products in stores or online that are known as personal sound amplification products (PSAPs). These are not alternatives to hearing aids.

While hearing aids and PSAPs both amplify sound for the user, the products have different intended uses. Hearing aids are intended to make up for impaired hearing. PSAPs, in contrast, are intended for people with normal hearing to amplify sounds in certain situations, such as recreational activities like birdwatching or hunting.

Because such PSAPs are regulated as consumer electronics and not medical devices, they may be more variable in terms of product quality compared to hearing aids. 

 

Over-the-Counter
(OTC) Hearing Aids

Prescription
Hearing Aids

(Any hearing aids that do not meet OTC requirements)

Personal Sound Amplification Products

Type of Product

Medical device

Electronic product

Medical device

Electronic product

Electronic product

Intended Users

  • People 18 years and older
  • For those with perceived mild to moderate hearing loss
  • People of any age, including those younger than 18 years
  • For people with any degree of hearing loss, including severe
  • People of any age with normal hearing to amplify sounds in certain environments

Conditions for Sale

  • Purchaser must be 18 years or older
  • No medical exam
  • No prescription
  • No fitting by audiologist
  • No need for licensed seller
  • Prescription needed
  • Must purchase from licensed seller in some states

No applicable FDA requirements regarding conditions for sale

 

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