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FDA Finalizes Ruling Allowing Americans to Buy Hearing Aids Over the Counter

On Aug. 16, the Food and Drug Administration (FDA) finalized a rule that will increase access to effective and affordable hearing aids across the country, potentially improving the lives of millions of Americans. When the rule becomes effective on Oct. 17, 2022, hearing aids will be allowed on store shelves for the first time.

In order to ensure only safe, high-quality hearing aids are sold over the counter (OTC), the FDA has created a new regulatory category for OTC hearing aids and will update related frameworks.

The Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, a report published by the FDA in August 2022, clearly defines hearing aids and outlines regulations for OTC hearing aids. This report was published to clarify which models and brands of hearing aids were allowed to be purchased OTC, so those in need of hearing aids would be getting types that were safe and effective, even when they were bought OTC.

Not just anyone can buy a hearing aid OTC. The ruling only allows consumers 18 and over with mild to moderate hearing loss to purchase a hearing aid without a medical exam or prescription.

However, this ruling still gives millions of Americans the chance to buy a low-cost hearing aid to improve their lives, something that would not have been possible before due to the high costs of the technology and the prescription requirement.

To put the impact of this plan into perspective, one can look at the costs of a hearing aid. Current estimates show that OTC hearing aids could cost $300 to $600 per device because they do not eliminate background noise the way prescription hearing aids do and they aren't professionally fitted or don’t involve professional services.

In comparison, a prescription hearing aid costs on average $2,300 per year. This drastic price difference is due to the limited number of brands that sell hearing aids and the personalized configuration that only prescription hearing aids have.

Ultimately, the FDA’s ruling makes safe, regulated, and affordable hearing aids available to a wider population of Americans. This rule will be life-changing for those who cannot currently afford professional hearing aids or do not have access to a prescription. Furthermore, it’s a step in the right direction for the Biden-Harris administration’s plan to provide more affordable health care for American families.


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