The Food and Drug Administration is moving closer to making more affordable over-the-counter hearing aids (OTC) a reality for millions of Americans with mild or moderate hearing loss. The agency issued a proposal create a category of approved devices that people can purchase without a prescription, hearing test, or fitting from an audiologist.
“The proposed rule is designed to help increase market competition while ensuring the safety and effectiveness of OTC and prescription hearing aids.” the FDA said. Around 15 percent of American adults (around 37.5 million) have hearing problems, according to the agency.
The FDA’s goal is to make it easier for those who might benefit from hearing aids to get a hearing aid – it says only a fifth of people who fall into this category use such a device. The agency hopes to overcome some of the barriers people might encounter, including cost, easy access, social stigma, and state and federal regulations.
In 2017, the federal government passed the Over the Counter Hearing Aids Act with the aim of improving access to cheaper hearing aids. Hearing aids are only available by prescription as they have been classified as Class I or II medical devices by the FDA. President Joe Biden signed an implementing regulation in July, partially instructing the Minister of Health and Human Services to publish a proposed regulation on OTC hearing aids within 120 days.
The proposal is now open to a 90 day public comment period. If the rule is final, it will come into force 60 days after its publication in the federal register.
Several companies have already taken steps to enter the OTC hearing aid market. Earlier this year, Bose began selling its SoundControl hearing aids after receiving FDA approval, while Jabra launched its Enhance Plus earbuds a few months ago. Other companies combine hardware and technology in hearing aids, including Bragi and Olive Union.
Apple recently updated AirPods Pro with a feature that increases the volume of other people’s voices in conversations while reducing ambient noise. The company is also said to be looking at ways to use AirPods as health devices.
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