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Will OTC Hearing Devices Be More Affordable?

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OTC Hearing Products

On August 16, 2022, the Food and Drug Administration (FDA) published its final rule establishing a new over-the-counter (OTC) hearing aids category.

The FDA’s new rules regulating over-the-counter hearing devices is expected to take effect this fall. Then hearing aid manufacturers will have 240 days to amend relevant product labels and marketing to comply with the new OTC requirements. As a result, OTC hearing aids will most likely be more affordable and accessible to consumers than most other FDA-approved hearing aids on the market right now.

Forbes’ recent article entitled “FDA Rule Allows Over-The-Counter Hearing Aids To Hit Shelves As Soon As October, Improving Access Nationwide” explains that direct-to-consumer hearing products include the following:

Personal Sound Amplification Products (PSAP). These are wearable hearing devices purchased from retail and online outlets that provide amplification of certain environmental sounds. They are often used while hunting, bird watching, listening in background noise, or listening to a public speaker. They shouldn’t be marketed as devices that assist those with hearing loss.

Assistive Listening Devices (ALD). These assist people who have hearing loss manage specific sound-related tasks, using light, vibration, or intense sound to alert someone to things like phones, lights, door chimes, and smoke alarms.

Wireless Hearing Aid Accessories. These hearing devices are designed to supplement a hearing aid and let a person stream information from a phone or other electronic device to improve their listening experience. (Typically, these are only available at an audiologist’s office and need to be set up there, but this will likely change with more hearing aid companies using Bluetooth 5.2 technology.)

Hearables. Hearables are ear-level devices, like earbuds or headphones, which enhance listening experiences like music streaming and face-to-face communication. But consumer beware – some hearables have no hearing enhancement function.

One of the main benefits of these types of hearing devices is that they help individuals with or without hearing loss to access sound so they can improve their quality of life.

For folks who may not yet realize they have hearing problems, using these devices helps them accept that they have hearing loss that can be helped and that they might benefit from hearing aids.

Reference: Forbes (Aug. 16, 2022) “FDA Rule Allows Over-The-Counter Hearing Aids To Hit Shelves As Soon As October, Improving Access Nationwide”


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