Personal sound amplification products

Personal Sound Amplification Products, also known as "Personal Sound Amplification Devices," or by the acronym PSAP, are defined by the U.S. Food and Drug Administration as wearable electronic products that are intended to amplify sounds for people who are not hearing impaired. They are not hearing aids, which the FDA describes as intended to compensate for impaired hearing. According to Dr. Mann of the FDA, choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing

Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. PSAPs are mostly off-the-shelf amplifiers for people with normal hearing who need a little boost in volume in certain settings (such as hunting and bird watching). Hearing aids contain a much higher level of technology prescribed to treat a diagnosed hearing loss. 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. As a result, there is no regulatory classification, product code or definition for these products. 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.

Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading glasses. 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. Of note, even reading glasses are regulated under the FDA. Companies such as Soundhawk, Etymotic, and Able Planet offer PSAPs that leverage technology and personalization.

PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids, although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption. 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 and are not covered by Medicare and many insurance plans.

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Wikipedia