The Food and Drug Administration has taken the first step to make hearing aids available to a much wider segment of the population, while bringing the cost down as well. And consumers could be able to buy them over the counter in less than a year.
Late Tuesday, the FDA unveiled a proposal that would establish a new category of hearing aids that would not require people to go through audiologists or physicians to obtain one. Essentially, it would create an auditory version of reading glasses, which are sold in outlets from drugstores to supermarkets.
The move comes after a multiyear push by lawmakers and hearing assistance companies to broaden the category. Over-the-counter models would cost considerably less than today’s hearing aids, which cost $5,000 on average, with health insurance often not covering those costs.
“Experts agree that medical evaluation is not necessary,” the White House said in a statement in July. “Rather, [the current] requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market.”
The move to make hearing aids more accessible and affordable is increasingly important, as hearing loss is expected to rise dramatically in the coming decades. The World Health Organization warns that by 2030, nearly 630 million people worldwide will have a hearing disability. By 2050, that could jump to 900 million, in part because of regular exposure to loud sounds at work and in people’s personal lives (such as by listening to music in earphones).
Currently, 15% of American adults (37.5 million) age 18 and over report some trouble hearing.
“Hearing loss has a profound impact on daily communication, social interaction, and the overall health and quality of life for millions of Americans,” said acting FDA Commissioner Janet Woodcock in a statement. “The FDA’s proposed rule represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options.”
As with corrective eyewear, over-the-counter hearing aids will not do away with the existing audiology industry. The proposal clarifies that hearing aids for severe hearing loss or for users younger than age 18 would still be prescription devices.
The FDA has not set a timeline for the proposal but called it a top priority. It will enter a 90-day public comment period, then it will likely become a final rule within 60 days of that. Afterward, hearing assistance companies will have 180 days to begin complying.
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