[2] PSAPs are not regulated under the Food, Drug and Cosmetic Act because they are not intended to treat, diagnose or cure hearing impairment and do not alter the structure or function of the body.
However, the FDA does regulate PSAPs under certain provisions of the Radiation Control for Health and Safety Act of 1968, covering electronic products such as sound amplification equipment that emits sonic vibrations.
[4] As such, PSAPs are suggested for use by hunters listening for prey, for bird watching, assistance hearing distant conversations or performances and amplifying the sound of a television in a quiet room, for example.
While some models simply amplify sound, others are more sophisticated designs, providing directional microphones and customizable equalization of the audio signal to clear up ambient or extraneous noise.
[8] Because they do not require medical examination and fitting, PSAPs range from as little as 50 to several hundred dollars in price, while custom hearing aids cost about $1400 on average[9] and are not covered by Medicare and many insurance plans.