WASHINGTON – Americans will no longer be required to get a medical examination before obtaining a hearing aid, the Federal Drug Administration announced Wednesday. The agency said it is encouraging the availability of hearing aids over-the-counter without prescriptions, saving U.S. citizens millions of dollars.
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, the FDA said.
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.
The FDA said Wednesday’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 the more of the 30 million Americans who need assistance.
Tens of millions of Americans currently suffer from mild to moderate 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, the agency noted, 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.
Some 30 million Americans currently suffer from mild to moderate hearing loss, which is often age-related.
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.
Due to the high cost and the overly burdensome steps needed to access hearing aids, the FDA said, 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.
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.
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, the agency said.
