FDA Takes Action to Deliver Lower-Cost, Innovative Hearing Aids to Millions More Americans

Today, the Food and Drug Administration (FDA) is launching a process to facilitate the availability of over-the-counter hearing aids—an announcement with the potential to positively impact millions of Americans.

Tens of millions of Americans currently suffer from hearing loss, often age-related, but many either don’t realize they’ve been affected or cannot afford basic hearing aids—which currently cost an average of $2,300 apiece. (That means, for a pair, most consumers are forced to plunk down a hefty sum of more than $4,600.)

Today, consumers can buy simple corrective lenses—reading glasses—over the counter, but the same is not true for hearing aids. And while hearing aids do not restore perfect hearing, allowing over-the-counter sale would facilitate the availability of more innovative, lower-cost products, enabling millions of people who are negatively impacted by hearing loss to better their daily lives. 

Why this matters, by the numbers:

30 million

30 million Americans currently suffer from hearing loss, which is often age-related.

>$2,300

Hearing aids currently cost an average of more than $2,300 apiece (i.e. for both ears, they cost an average of more than $4,600.) Over-the-counter products offer the prospect of bringing these costs down into the hundreds—instead of thousands—of dollars.

< 1/5

Due to the high cost and the overly burdensome steps needed to access hearing aids, fewer than one in five Americans who could benefit from technology to help them hear better actually get the assistance of a hearing aid. Many of these consumers who don’t suffer from severe hearing loss just need help hearing a little better in a loud restaurant, for example.

10,000

Roughly 10,000 Americans are turning 65 every single day. Over 25 percent of Americans aged 60-69 have hearing loss, and that rises to over 50 percent for 70-79 years of age and over 75 percent for Americans aged 80+ years. The ongoing retirement of the baby boomers and increased longevity mean that the number of Americans who could benefit from an over-the-counter hearing aid will only be growing. That’s why AARP and the Hearing Loss Association of America (HLAA) have both supported allowing an over-the-counter product.

6

Currently only six manufacturers produce nearly all hearing aids, and only one of those companies is based in the United States. Opening up the hearing aid market to innovative, lower-cost, over-the-counter options brings with it the prospect of expanding the number of options for consumers and creating opportunities for economic growth and job creation in the United States. That’s why consumer electronics stakeholders representing innovative American companies have supported expanding the options and technologies available.

So, what happens next?

As a first step toward breaking down barriers, FDA has announced that it does not intend to enforce the requirement for American adults to get a medical evaluation before obtaining most hearing aids. The vast majority of people waive this requirement already. Currently, audiological services are bundled into the overall price of a hearing aid—and the market is constrained by bulk purchasing arrangements between hearing aid dispensers and the major manufacturers. Allowing the sale of over-the-counter hearing aids has the potential to deliver tens of millions of Americans the prospect of better hearing at much lower cost by increasing competition and innovation in the hearing aid market.

In 2015, the President’s Council of Advisors on Science and Technology (PCAST) examined the technology, regulation, and marketplace of hearing aids, leading them to recommend that FDA approve an over-the-counter device.  Now—after a two-year study by the National Academies of Sciences, Engineering, and Medicine that also called for an over-the-counter product in alignment with the PCAST recommendation—FDA is announcing it’s ready to take the necessary steps to move forward. Today’s actions are yet another in a series in response to President Obama’s Executive Order promoting competition to benefit consumers, workers, and small businesses.

The Bottom Line

Today’s announcement could start a movement toward over-the-counter hearing aids that will cost a fraction of the $2,300 apiece of current products, helping more of the 30 million Americans who need assistance.

Charlie Anderson is a Special Assistant to the President for Economic Policy. Ashley Predith is the Executive Director of PCAST.