The FDA Is Helping Millions Of Americans Hear Better. Finally.

Hearing aids are too expensive, too clunky and too hard to get, which means many Americans go without devices that would substantially improve their quality of life. That is why the Food and Drug Administration’s Tuesday announcement that it is finally shaking up the hearing aid market is such a big deal.

The FDA finalized a rule that would allow people with mild to moderate hearing loss to buy hearing aids over the counter — no prescription, no haggling with insurance, which usually does not cover the devices, and no audiologist visit. This move will also allow people to bypass complex and unnecessary state-level restrictions, which often limit who can sell hearing aids and when, inhibiting patients from shopping around for the best products and discouraging manufacturers from competing on cost and quality.

People previously deterred by all the requirements and hearing aids’ high cost — they currently average about $5,000 a pair — will be able to walk down a drugstore aisle and select whatever device they prefer. There, they might find a variety of options from companies previously deterred from entering the hearing aid market, who will flock to provide lower-cost and better-functioning devices.

Lauding the decision, President Biden claimed these market forces would drive down costs by nearly $3,000 per pair. Innovation might happen quickly, as it does in the consumer tech market for products such as smartphones and audio headsets. Advanced phone integration, smaller sizes, better software permitting smarter noise canceling and clearer hearing in crowds are just some of the possibilities.

People with severe hearing loss will still have to seek medical evaluation, because only basic hearing aids will be sold over the counter. And consumers will have to be careful that they get all the care they need; if a basic hearing aid isn’t cutting it, or symptoms suggest a serious health problem, professional treatment is necessary. But some 38 million Americans say they have at least some hearing loss, and most do not have hearing aids. A vast number of people suffering from low-level hearing degradation could suddenly have reasonable options.

So, why didn’t the FDA do this years ago? Advisers to President Barack Obama recommended this policy shift back in 2015. Congress in 2017 ordered the FDA to propose a rule within three years. The agency missed that deadline. The timetable was not unreasonable; the FDA’s slow pace was. The agency points out that the covid-19 pandemic hit in 2020, just as its deadline approached. But, while it’s true the agency had to scramble to evaluate covid-19 tests and address other pressing pandemic needs, it had plenty of time to act before the pandemic.

Mr. Biden had to issue his own order last year pushing the agency to finish up. That appeared to work: The FDA proposed a rule last October. Then the agency was obliged to sort through more than 1,000 comments on its proposal. So, only now, two years after Congress’s deadline for the FDA to propose the new policy, is the rule finally complete. This case study in bureaucratic delay, while millions of Americans waited for cheaper, better and easier-to-obtain hearing aids, should spur some soul-searching at the FDA and questions from Congress.

Meantime, tech companies should race to furnish a suddenly wide-open market with more, smarter hearing aids that cost less.


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