After five years, the U.S. FDA has finally released a final rule for over-the-counter hearing aids along with an associated guidance, a development that was stipulated by the FDA Reauthorization Act (FDARA) of 2017. Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, was among several HHS officials who appeared on the Aug. 16 briefing to tout the rule, each of which promised that the rule would spark competition that would in turn take a significant bite out of the cost of acquiring a hearing aid.

The draft rule emerged in October 2021, roughly a year after the date required by FDARA, and the final rule is effective in 60 days, or Oct. 15. Devices that are already on the market have 240 days to come into compliance, and Becerra said at the outset of the Aug. 16 briefing, “today is a stand-out day.” He noted that an appointment with an audiologist or a physician has been required up to now even for those with only mild to moderate hearing impairment, adding that the concomitant lack of access is a burden not just on the hearing impaired, but also on their loved ones.

Robert Califf, commissioner of the FDA, said the rule allows consumers to obtain a hearing aid without a medical exam, and allows purchases online and in brick-and-mortar retail establishments. The rule is “the result of years of work and engagement” with stakeholders, Califf said, adding that only about 20% of those who could benefit from a hearing aid are currently using one. He said he expects manufacturers to come up with devices that significantly improve hearing in these populations, adding that consumers should see OTC items available as early as October. The expectation that savings will arrive that quickly is premised on the notion that manufacturers have been preparing for the final rule for some time, and thus are at the ready with devices that are properly labeled and in inventory for shipment as of the effective date of the rule.

Brian Deese, director of the White House’s National Economic Council, said the requirement to see a physician or hearing specialist kept more innovators from entering the market to compete, and impeded efforts on the part of consumers to compare devices on the basis of cost and features. The existing regulation was “an example in which the regulation itself was getting in the way,” of competition, Deese said, adding that the FDA expects the rule to save consumers about $1,400 per hearing aid device. Califf said that $5,000 for a pair of hearing aids is not an uncommon estimate of device cost. Assuming such estimates are reliable, the cost reduction of $1,400 per device could shave more than half the cost from obtaining a device on an OTC basis.

Califf said the final rule was not available earlier this year in part because of the sheer volume of comments to the draft rule. He noted that the illicit sales of hearing aids in the 1970s might have provoked over-regulation on the FDA’s part, thus the current, seemingly anticompetitive environment.

Kate Carr, president of the Hearing Industries Association, said the final rule “is a significant step forward for the millions of Americans who suffer hearing loss yet are untreated.” Carr said, however, that hearing loss “is unique to each person, and most do not know if their condition is mild, moderate, or greater,” let alone the source of the hearing loss. While the association supports the final rule, Carr said HIA maintains that “the best treatment for hearing loss involves seeing a hearing professional.”