FDA proposes rule for over-the-counter hearing aids

·Contributing Writer
·2 min read

The Food and Drug Administration is moving closer to making more affordable over-the-counter (OTC) hearing aids a reality for millions of Americans with mild or moderate hearing loss. The agency issued a proposal to create a category of approved devices that people would be able to buy without a prescription, hearing exam or having to arrange a fitting with an audiologist.

"The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids," the FDA said. Around 15 percent of adult Americans (some 37.5 million) have hearing difficulties, according to the agency.

The FDA's goal is to make it easier for those who could benefit from hearing aids to actually get one — it says only a fifth of people who fall into that category use such a device. The agency is hoping to tackle some of the barriers people might encounter, including cost, ease of access, social stigma and state and federal regulations.

In 2017, the federal government passed the Over-the-Counter Hearing Aid Act with the aim of improving access to more affordable hearing aids. Hearing aids have only available with a prescription as the FDA classed them as Class I or II medical devices. President Joe Biden signed an executive order in July that, in part, instructed the Secretary of Health and Human Services to publish a proposed rule for OTC hearing aids within 120 days.

The proposal is now open to a 90-day public comment period. If and when the rule is finalized, it will come into effect 60 days after it's published in the federal register.

Several companies have already made moves to gain a foothold in the OTC hearing aid market. Earlier this year, Bose started selling its SoundControl hearing aids after gaining clearance from the FDA, while Jabra unveiled its Enhance Plus earbuds a couple of months ago. Other companies are blending hardware and tech in hearing aids, including Bragi and Olive Union.

Apple, meanwhile, recently updated AirPods Pro with a feature that amplifies the volume of other people's voices in conversation while reducing ambient noise. The company is also said to be looking into ways of using AirPods as health devices.

Update 10/21 11:08AM ET: Noting that Bose gained clearance from the FDA for SoundControl, rather than approval.

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