More over-the-counter hearing aids are a benefit to consumers.
Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017 to allow over-the-counter sales, with hopes it would boost competition and lower prices.
Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief.
In August 2017, President Donald Trump signed the legislation that called for the Food and Drug Administration to issue regulations by 2020 for hearing aids that could be sold in stores without a prescription or a visit to a hearing specialist. That hasn’t happened yet, and President Joe Biden last month ordered the FDA to produce those rules by mid-november. That means it will probably take at least until next summer for consumers to feel the direct effects of the law.
Despite the delay, consumers’ options have expanded, with more hearing devices entering the market, alternative ways to get them and lower prices.
Leading consumer brands Apple and Bose are offering products and several smaller companies sell aids directly to consumers, providing hearing tests and customer service online from audiologists and other hearing specialists. Even major retailers offer hearing aids directly to consumers and provide audiology services online: Walgreens stores in five Southern and Western states sell what the chain calls “Fda-registered” Lexie hearing aids for $799 a pair — far less than half the price of typical devices.
Nationally, personal sound amplification products, or PSAPS, that are smaller and customizable are now available in stores and online. These devices, which look like hearing aids and sell for a fraction of the price, amplify sounds, but some do not
address other components of hearing loss, such as distortion.
“There are many more options than there were in 2017 when
Trump signed the Hearing Aid Act into law,” said Nancy Williams, president of Auditory Insight, a hearing industry consulting firm in New Haven, Connecticut. “In a sense, you can say the over-the-counter (OTC) revolution is happening without the FDA, but the difficulty is it is happening more slowly than if the FDA issued its rules on time.”
The price for a pair of standard hearing aids typically ranges from $2,000 to $8,000. That price includes the professional fitting fees and follow-up visits. The hearing aid industry has remained largely insulated from price competition because of consolidation among manufacturers, state licensing laws that mandate sales through audiologists or other hearing professionals, and the acquisition of hearing professionals’ practices by device makers.
The federal law creates a category of hearing aids that would legally bypass state dispensing laws and enable consumers to buy aids in stores without consulting a hearing aid professional. Users would be expected to program the devices through a smartphone, and companies could offer service via phone or internet.
“The FDA delaying regulations has done more harm than good, because the direct-to-consumer market is filling the void and people are doing what they want, and we don’t know the quality of these devices,” said Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer advocacy group.
Brandon Sawalich, CEO of Starkey, the largest U.s.-based hearing aid company, said consumers need expert assistance to test their hearing, buy an appropriate aid, properly fit it and fine-tune its settings.
“It’s not just picking up something off the shelf at your local drugstore or ordering something online and putting it in your ear and your life is going to be reconnected and you are going to hear perfectly again,” he said on a recent podcast. “It doesn’t work that way, and it’s not that easy.”
However, by avoiding professional help, more Americans are likely to get hearing assistance. “The OTC and direct-to-consumer options open up avenues for those who have no other path to get hearing aids,” said Hope Lanter, a Charlotte, North Carolina, audiologist with Hear.com, a Netherlands-based online hearing aid retailer.
She expects that after the FDA issues its rules many hearing aid manufacturers will develop lower-cost, over-the-counter devices that can be obtained without an audiologist’s evaluation.
“In my view, there is enough pie for everyone,” Lanter said, noting that millions of people with hearing loss are not getting any help today. More than 37 million American adults have trouble hearing, including nearly half of people over age 60. Only 1 in 4 adults who could benefit from a hearing aid have ever used one, federal health officials estimate.
Unlike most consumer electronics, hearing aids have remained expensive for decades, generating consumer complaints. Industry experts predict new over-the-counter hearing aids will be priced at less than $1,000 a pair.
Without federal rules in place, manufacturers have largely waited to develop devices for the OTC market.
Bose chose a different path. This spring it began selling its hearing aids, which can be purchased online without a doctor visit, hearing test or prescription. Bose gained FDA clearance in 2018 after providing data showing the effectiveness of its self-fitting aids was comparable to that of similar devices fitted by a hearing professional. The Bose aids sell for $849 a pair.
Meanwhile, Apple last year integrated hearing assistance into its popular Air Pods Pro earbuds, which can be customized using settings on an iphone.
Apple is not marketing the free benefit as a hearing aid but instead as similar to a PSAP that amplifies sound to help hearing.
Several companies such as Eargo, Lively and Lexie allow consumers to buy aids online and get help from specialists to set them up remotely. As long as companies have generous return policies that enable people to try a couple of aids to see which works best, the proliferation of online options selling high-quality aids is good news for consumers, said Williams, the Connecticut-based hearing consultant.