After years of internal debate, the FDA has approved the sale of over-the-counter hearing aids. The move will make the devices available to consumers with mild to moderate hearing loss as soon as mid-October.

The move not only could save a typical buyer several thousand dollars, it also opens the door to potential new technologies that could improve the quality of life for millions of older adults and others with hearing loss. In anticipation of the new rule, companies such as Apple and Bose have been developing new products that will be less costly and, perhaps, more effective, than current devices.

The new rule means US consumers will, for the first time, be able to buy hearing aids in a store or online without having to see a doctor or get a prescription. Roughly 37 million people in the US—more than 10 percent of the population—suffer from hearing loss. And nearly 30 million could benefit from hearing aids, according to the National Institutes of Health (NIH).

However, only about one-third of those age 70 or older, and only about 16 percent of younger adults with hearing loss ever have used hearing aids, NIH estimates. Even though hearing loss can lead to depression, cognitive decline, and social isolation.

Many with hearing limitations are older adults, though the new rule applies to anyone age 18 or older.

Why people don’t buy

There are many reasons people don’t get the devices, including denial and fear of social stigma. But a big reason is cost. A pair of prescription hearing aids can cost as much as $4,000 to $5,000. The devices  are not covered by traditional Medicare or private insurance and only partially covered by Medicare Advantage managed care plans. Some experts predict the new over-the-counter aids will be priced at between $200 and $800.

Last year, Democrats toyed with allowing Medicare to pay for hearing aids, as well as expanded vision and dental coverage. But they dropped that idea when it became clear it would not pass Congress.

Keep in mind that some devices aimed at improving hearing already are sold without prescriptions in retail stores or online, but they technically don’t meet the FDA definition of hearing aids.

Congress gave the FDA authority to permit non-prescription hearing aids five years ago. Last summer, President Biden made this change a top priority. Last October, the agency first proposed the rule adopted today.

A near-monopoly

The process was slow in part because regulations always take a long time to write, especially when they have the potential to change an industry. But these rules may also have been slowed because the established manufacturers and some physicians who do hearing exams and write prescriptions raised objections.

In a June report, the Senate sponsors of the original bill to give FDA authority to approve over-the-counter devices, conservative Chuck Grassley (R-IA) and liberal Elizabeth Warren (D-MA), called the hearing aid industry a near-monopoly. They said just five companies produce 90 percent of US hearing aids. They also accused the companies of creating fake grassroots consumer opposition to the new rules (known in the political business as astroturfing).

Safe and effective

One big issue these industry critics raised was whether new over-the-counter (OTC) technology would have to meet the same FDA standards as current hearing aids.

Importantly, the agency chose to give makers of new tech quite a bit of leeway. The rules say, “We agree that OTC hearing aids must meet the same standard as other devices for having reasonable assurance of safety and effectiveness…and that OTC hearing aids be subject to the quality system requirements applicable to other devices. However, we note that different device types and categories will raise different issues related to safety and effectiveness.”

In English: While the new devices must be safe and effective, they don’t need to fit in the same regulatory box as the current hearing aids.

The hearing aid business has been a textbook case of how, in the name of health and safety, government regulations limit both competition and innovation. The government still needs to protect consumers from bogus or dangerous products but it can do that without stifling innovation.

The FDA’s decision to allow consumers to buy hearing aids over the counter without prescriptions will improve the quality of life for millions of older adults and others with hearing loss.

Now, if only Medicare would pay for them.