Currently, there are two main categories of amplification products. 

Hearing aids are FDA-regulated medical devices that are intended to compensate for and correct hearing impairment.​ Personal Sound Amplification Products (PSAPs) are consumer electronic products intended to increase environmental sounds for non-hearing-impaired consumers. For patients with hearing loss, this distinction is critically important to factor in your health care decision-making process. 

Hearing Aids 

• Hearing aids are already regulated by the FDA.
• These devices 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.
• 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.​​

PSAPs

• ​PSAPs are designed to amplify all sounds and can be useful in specific situations only to consumers with normal hearing. 
• ​They are not medical devices and are not regulated by the FDA for safety or effectiveness.​
• The FDA has warned consumers that PSAPs are not intended to compensate for impaired hearing or to address listening situations that are typically associated with and indicative of hearing loss. 
• If the maximum output allowed for these devices is too high, the risk is increased that these individuals will be over-exposed to loud sound and potentially develop noise-induced hearing losses.

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