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.^[1] However, PSAPs can be a useful alternative to a hearing aid.^[2]

Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. While the technology and function of PSAPs and hearing aids are similar, 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.^[3]

Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading glasses.^[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.^[3]

Various models of PSAPs from a variety of manufacturers vary in price, performance, weight, user experience and the software algorithms to enhance and tailor hearing. 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.^[5] Companies such as Soundhawk, Etymotic, Advanced bionics, and Able Planet offer PSAPs that leverage technology and personalization.^[6]

PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids,^[7] although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption.^[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.^[4] As much as 70 percent of the final price of a hearing aid can be accounted for by additional services from audiologists that are bundled in to the price.^[10]

According to the National Institute of Deafness and Other Communication Diseases, of the 36 million Americans who might benefit from a hearing aid, only about 20 percent actually use one.^[4] However, a 2010 survey indicates that fewer than 18 percent of PSAPs were used as a substitute for custom hearing aids and concludes that the majority of PSAP users would have lived with their hearing loss because of the higher price of hearing aids.^[9]

Many PSAPs are sold direct to the consumer through online stores, at pharmacies and through many drugstore and retail store chains.

Sound amplifiers work by absorbing an incoming audio signal and boosting the power of it before turning it into a physical sound wave to be played through a speaker. The microphone that picks up the incoming audio and the speaker that plays the resulting boosted signal are found within the same tiny device. This technology allows for a weak audio signal to be boosted in power while still conveying the same audio.

The job of an amplifier is to get a larger output from a small electric current. There are many ways this can be achieved depending on the signal. A fluctuating signal, such as with a television or the sound of a voice coming down the telephone line is the same as a microphone from a hearing aid. The amplifier used for this is a transistor based. This type of amp has 3 main components starting with a base of 3 wire connections. When a small current is fed to the emitter from a base, you get a much larger output flowing to the collector from the emitter.

While this may sound as if energy, or voltage, would be emitted also- physics come into play and no energy is created. That’s why an energy hook-up or supply is needed by having external batteries for a hearing aid, or ear amplifier.^[11]

References