Personal sound amplifier or hearing aids

REGULATION

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There has been concern in the hearing device industry that the distinction between hearing aids and personal sound amplifier products (PSAPs) is not very clear to consumers. Although the two products share a common goal, enabling users to hear better, and often have common technology, there are significant differences that the buyer should be aware of. Wisconsin news and talk radio station WTAQ reports on what consumers should know.

In this area, the saying “you get what you pay for” really does apply. This is the first immediately visible difference between the two. PSAPs are sold for about USD 100 to 300, while professionally fitted hearing aids, providing a very different service, cost significantly more. Second, PSAPs are not intended to correct hearing loss. As their name implies, they are suitable for situations where people with normal hearing would like to hear low level sound. Examples include hunting, bird watching, listening to a quiet TV in a room where someone else is sleeping, and listening to lectures with a distant speaker. As such, they amplify all sound and unlike hearing aids, do not separate tones and volumes or adjust to different environments.

In November, the US Food and Drug Administration (FDA) issued a new draft guidance on requirements for manufacturers and marketers of hearing aids and PSAPs. The aim was to indicate the notable distinctions that exist between the two types of devices, despite their similar use. Importantly, PSAPs are not considered medical devices and are therefore not regulated by FDA. If, however, the labeling makes claims referring to use by the hearing impaired, the product would fall under hearing aid regulations.

More on this subject

Source: WTAQ, Regulatory focus

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