Friends, Romans, countrymen, lend me your ears. After years of urging from both the government and the public, the FDA has established a new device category that’ll allow certain hearing aids to be sold over the counter directly to consumers.
The newly finalized rule (PDF)—which was filed Tuesday in the Federal Register and is slated for official publication Wednesday—enables adults with mild to moderate hearing impairment to purchase air-conduction hearing aids without a prescription, medical exam or fitting adjustment appointment. These hearing aids are typically worn in or behind the ear and don’t require a surgical implant.
Devices intended for users who are under the age of 18 or who have severe hearing loss will still require a doctor’s order.
The rule will take effect 60 days after its publication, meaning people could begin buying over-the-counter hearing aids online and in retail and drugstores as soon as mid-October, the FDA noted in a Tuesday press release.
Devicemakers currently manufacturing and selling hearing aids will have about eight months from the rule’s publication date to comply with its requirements, while those planning to join the fray will need to meet the new criteria from the get-go.
Already expected to throw its hat in the new direct-to-consumer ring is Lexie Hearing, which recently took over Bose’s SoundControl hearing aid portfolio. It’ll likely be joined by “invisible” in-ear device maker Eargo and GN Audio’s Jabra brand, which kicked off 2022 with the launch of its own self-fitting, sound-enhancing earbuds.
According to the agency, the primary goal of the much-awaited move is to make hearing aids more affordable and accessible to the estimated 30 million adults in the U.S. who may benefit from the devices—only about 20% of whom currently use them. The average price of a hearing aid currently ranges between $1,000 and $4,000; in contrast, a direct-to-consumer option introduced by Bose last year clocks in at just under $900 per pair, while Jabra’s earbuds are set at the low, low price of $799.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Robert Califf, M.D., said in the release. “Establishing this new regulatory category will allow people with perceived mild-to-moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
The origins of the rule date back to 2017, when Congress passed bipartisan legislation ordering the FDA to create the over-the-counter hearing aid category. President Joe Biden re-upped that demand last summer with an executive order that called on the U.S. Department of Health and Human Services to publish a proposed rule within 120 days of the order—again, with the aim “to promote the wide availability of low-cost hearing aids.”
That proposal arrived in October and included a slate of criteria for the included devices, governing their maximum volume limits and other design and performance specifications to ensure they work as effectively as possible.
The finalized version of the rule slightly tweaked those criteria based on the more than 1,000 public comments the FDA received from consumers, devicemakers, government entities and more.
According to the agency, those changes include, among others, “lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control and simplifying the phrasing throughout the required device labeling to ensure it is easily understood.”