Over-the-counter hearing aids in the U.S. are officially becoming a reality. On Tuesday, the Food and Drug Administration finalized the regulations needed for hearing aids to become widely available without a prescription. These OTC aids may save money for millions of Americans with poor hearing and are expected to reach retail shelves in as little as two months.
The arrival of OTC hearing aids has been a long time coming. Five years ago, as part of the FDA Reauthorization Act of 2017, the FDA was tasked with developing regulations that would create a new category of hearing aids that could be sold in traditional retail or online outlets. In July 2021, President Biden signed an executive order that, among many other things, pushed the FDA to speed along its regulatory process. By late October 2021, the FDA released its proposed rules for these products, and on Tuesday, the agency issued its final language on them.
About 15% of Americans over the age of 18, or almost 40 million people, are thought to be affected by hearing loss, while about 28 million Americans could benefit from hearing aids, according to the National Institute on Deafness and Other Communication Disorders. But relatively few people take advantage of them, with less than a third of those over 70 and an even smaller percentage of adults between 20 and 69 (16%) having ever used a hearing aid.
Some major reasons for this disparity have been money and accessibility. Today’s hearing aids either require a visit to a doctor or hearing loss specialist as well as a prescription, or have to be purchased through specialty stores. And the entire process can cost upwards of $2,000, costs that often aren’t covered by insurance. While the exact prices of OTC aids aren’t clear yet, they’re certain to be cheaper in general and easier to obtain.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
The rule will only allow certain types of hearing aids to be sold over-the-counter. Hearing aids for children under 18 will remain prescription-only, for instance. In addition, OTC products will only be intended for people with mild to moderate hearing loss. And in response to input from hearing loss experts and relevant organizations to its original proposed regulations, the FDA will also mandate that products have a lower maximum sound output and user-adjustable volume setting to reduce the risk of injury.
In addition to its new regulations on OTC hearing aids, the FDA also issued its final guidelines on personal sound amplification products (PSAPs). These consumer products, often sold online or through infomercials, have to be marketed as devices that can improve a person’s normal hearing and are not intended for those with hearing loss.
While OTC aids will be most prominently sold in drugstores and can be self-fitted, it’s also likely that hearing loss doctors will start to offer them through their clinics as well. Some surveys have suggested that many people may still want a hearing test and a doctor’s consultation beforehand to ensure that OTC aids will provide them with enough improvement to be worthwhile.
The FDA’s rule will take 60 days to come into effect, and manufacturers will have 240 days to make any needed adjustments. So if everything goes as well as planned, OTC hearing aids will be sold in stores as early as mid-October.