Currently, there are two main categories of amplification products: Hearing aids and personal sound amplification products (PSAPs).
Hearing aids are medical devices which are intended to compensate for and correct hearing impairment. Hearing aids are already regulated by the FDA. Hearing aids are typically dispensed only after a hearing care professional performs a thorough hearing test and then programs the device to the specific hearing needs of each individual. The hearing care professional provides a comprehensive set of services such as hearing evaluations, counseling on the best hearing care solution, device fitting, education and training on how to use the hearing aid, and adjustment of the hearing aid to achieve the best outcome for the individual. In other words, hearing health professionals ensure that hearing aids are used safe and effectively.
PSAPs are consumer electronic products intended to increase environmental sounds for non-hearing-impaired consumers. They are not medical devices and are not regulated by the FDA for safety or effectiveness.
Given the difference in usage, the characteristics that make a good PSAP are very different than those that make a good hearing aid. PSAPs are designed to amplify all sounds and can be useful in specific situations only to consumers with normal hearing. Conversely, hearing aids use far more advanced technology to amplify speech from one specific direction and, at the same time, to reduce or cancel background noises coming from all other directions. These features can make a significant difference in speech intelligibility in any noisy environment.