The Food and drug administration Over-the-counter (OTC) hearing aids for millions of Americans with mild or moderate hearing loss are moving closer to making. The company has issued a Proposal Creating a category of approved devices that people will be able to buy without a prescription, hearing test or fitting with an audiologist.
“The proposed rule is designed to help increase market competition and ensure the safety and effectiveness of OTC and prescription hearing aids.” The FDA says. According to the agency, about 15 percent of adult Americans (about 37.5 million) have hearing problems.
The FDA’s goal is to make it really easy for those who may benefit from hearing aids – it says that only one-fifth of those in this category use such devices. The agency hopes to address the costs, ease of access, social stigma and barriers that people may face, including state and federal regulations.
In 2017, the federal government passed the Over-the-Counter Hearing Aid Act aimed at improving access to more affordable hearing aids. Hearing aids are only available with a prescription because the FDA classifies them as Class I or II medical devices. President Joe Biden Has signed an executive order In July, in part, the Secretary of Health and Human Services was instructed to publish a proposed rule for OTC hearing aids within 120 days.
The proposal is now open for a 90-day public comment period. If and when the rule is finalized, it will take effect 60 days after it is published in the Federal Register.
Several companies Already OTC has taken steps to set foot in the hearing aid market. Earlier this year, Bose Start selling Its soundcontrol hearing aids after FDA approval, when Jabra unveiled it Plus improve earbuds A couple of months ago. Other companies are mixing hardware and technology, including hearing aids Bragi And Olive Union.
Apple, meanwhile, recently AirPods Pro has been updated A feature that enhances other people’s voices in conversation while reducing ambient noise. The company is also reportedly looking for ways Using the AirPod as a health device.
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