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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 Deaf or Hard of Hearing.
An OTC hearing aid can correct for a personalized mild to moderate hearing loss, while a PSAP increases the volume at all frequencies and is not meant to fit an individual's hearing loss.
The hearing aid market has advanced by leaps and bounds since the FDA's 2022 regulatory change allowing hearing aids to be sold over the counter. The greatly increased competition between ...
Hearing aids are able to amplify and process these sounds, and improve the speech to noise ratio. However, if the sound is too distorted by the time it reaches the listener, even the best hearing aids will struggle to unscramble the signal. Assistive listening devices offer a more adaptive alternative to hearing aids, but can be more complex ...
OTC hearing aids like Zepp Clarity use the same basic technology as some prescription hearing aids. They amplify sounds using a microphone, amplifier, and speaker but do not require custom molds ...
Hearing aids are classified as medical devices in most countries, and regulated by the respective regulations. Small audio amplifiers such as personal sound amplification products (PSAPs) or other plain sound reinforcing systems cannot be sold as "hearing aids".
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