US approves over-the-counter hearing aid sales

The Food and Drug Administration on Tuesday approved the sale of hearing aids without a prescription, allowing millions of Americans to purchase hearing aids without seeing an audiologist and saving individuals thousands of dollars.

US approves over-the-counter hearing aid sales. The rules, which will take effect in mid-October, apply to hearing aids for people with mild to moderate hearing loss. The devices will be available directly in stores or online without a medical exam, prescription or audiologist adjustment. Brian Deese, Director of the White House National Economic Council, said the government estimates that the rule will save consumers about $2,800 per pair of hearing aids and could help "tens of millions of Americans." In 2017, Congress passed a law requiring the FDA to create a category for over-the-counter hearing aids, but the law has not been fully implemented. In June 2021, President Joe Biden signed a broad competition executive order instructing the Department of Health and Human Services to "promote the wide availability of low-cost hearing aids" among directives to various industries. Some Democrats, such as Representative Debbie Dingell, want Medicare, the government health insurance program for seniors, to cover the cost of hearing aids. The new category applies to hearing aids for adults with mild hearing loss. The FDA's final rules for the sale of over-the-counter hearing aids lower the maximum sound output to reduce the risk to hearing from excessive amplification of sound, revise the ear canal insertion depth limit, require user-adjustable volume control, performance features and device design requirements. The Hearing Industries Association, which represents hearing aid manufacturers, suppliers, distributors and hearing health professionals, says the new rule "will expand access to hearing aids among the estimated 38 million Americans who experience mild to moderate hearing loss." Republican Senator Chuck Grassley said the final rule was "good news for consumers" and said the measure would "lower prices" and result in "more competition".