The government on Monday will begin allowing pharmacies and big-box stores to sell hearing aids without prescriptions, a move that is expected to shake up an industry that has long been dominated by a handful of manufacturers under a model of care that critics said raised costs and stifled innovation.
But while the shift holds the promise of improving the lives of millions of people who have untreated mild to moderate hearing loss, it also is a sweeping test of consumer-driven health care.
For first-time users, hearing aids require fine-tuning and a degree of patience as the brain becomes accustomed to processing sounds that have been muffled for years, say audiology experts. It’s not like popping on a new pair of glasses and instantly seeing clearly. It sometimes takes days or weeks to become accustomed to them, which might be easy for tech-savvy people but more challenging for the target audience of elderly people.
Manufacturers say they are ready to smooth the process for new customers. Today’s hearing aids come with smartphone apps that allow consumers to calibrate the devices themselves. The manufacturers are setting up call centers and help desks to assist customers with fit and tuning.
Moreover, with millions of new customers on the horizon representing billions of dollars in sales, they are gearing up for competition over price, sound quality, design and multiple functions like call-streaming and music.
“It’s going to be the wild, wild west for a few years, but I mean that in a good way,” said Frank Lin, director of the Cochlear Center for Hearing and Public Health at Johns Hopkins’s Bloomberg School of Public Health. “There is so much market opportunity here. It’s never been done this way.”
The substantial learning curve will be a worthwhile trade off for consumers, giving them more options without having to see a doctor, said advocates. The Food and Drug Administration has limited retail, no-prescription sales to devices designed for people 18 and older with mild to moderate hearing loss.
“The benefit that is likely to happen is going to outweigh the complexities we need to learn how to navigate,” said Meaghan P. Reed, director of audiology at Massachusetts Eye and Ear, a Harvard-affiliated treatment and research hospital. With lower costs and easier access, she said, it’s likely to “force some changes in the hearing health industry.”
Yet most medical insurance plans, including traditional government Medicare insurance for the elderly, do not cover hearing aids or audiology visits for fitting, which will continue to limit access for many people, Reed said.
Two early entrants into retail sales, Lexie and Jabra, are manufacturing over-the-counter devices that sell for $799 per pair. While some prescription hearing aids go for as low as around $2,000 a pair, they are typically sold alongside audiological services, which often brings the total price to around $4,000 to $8,000.
A Lexie executive said in an interview that its devices will be available in 11,000 retail stores including Walgreens, Walmart and Best Buy. Jabra — which is part of GN Group, a Danish firm that also owns Resound, one of the five traditional hearing aid manufacturers — said its combination streaming earbud and hearing aid will be in 300 Best Buy stores starting Oct. 24.
Walgreens said Lexie hearing aids, which are made using Bose technology, will be sold from behind the pharmacy counter. Purchasers will be directed to Lexie’s website, which has online hearing tests and contact information for help desks, the company said. Lexie said it plans to compete on the quality of its customer service and the ease of use of its app, in addition to sound quality and design.
“The traditional hearing aid players have been controlling the pie for the last couple of decades, and it remains to be seen how large the category is going to be,” said Seline van der Wat, chief operating officer of Lexie, a division of South Africa-based hearX Group. By selling directly to people with mild to moderate hearing loss, she added, over-the-counter sales are going to “create a whole new pie.”
Lexie’s Instagram marketing account, hearingwithlexie, features pitches for $42-per-month payment plans and testimonials. One of them sets high expectations: “Worked great right out of the box. I can hear again,” says a quote from someone it identifies as Kenneth D., a smiling man with a white beard who appears to be hooking a device around his ear.
Aside from certain high-cost cancer drugs and other pharmaceuticals, as well as some durable medical equipment, $800 hearing aids will be among the highest priced items at Walgreens stores. The pharmacy chain believes the pandemic has proven — through the use of rapid tests and more reliance on telehealth, for example — that consumers are primed to handle more medical needs with greater independence, said Luke Rauch, senior vice president and chief merchandising officer at Walgreens.
“Health care is moving to the home. Anything we can do to accelerate and enable that pivot, to have health care uber-localized and something you can do from the confines of your own home, that is the bull's eye of the mission that we have,” Rauch said.
CVS, without citing specifics, said it will have hearing aids in its stores in November and will start online sales this week.
Hearing specialists are excited that more people with untreated hearing loss will have access to crucial devices. Untreated hearing loss can lead to cognitive decline, isolation and dementia, but only a fraction of the 28.8 million who could benefit from hearing aids use them, according to the National Institute on Deafness and Other Communication Disorders. Of those who could benefit, just 16 percent of adults under 69 and just 30 percent over 70 have them, the agency said.
Studies have shown that it takes up to seven years from the time someone first learns they have hearing loss to the point they purchase a hearing aid. Cost and negative stigma are often the biggest factors, say specialists, and over-the-counter sales can ease those consumer concerns.
“There will be more people that will move away from the denial aspect because financial issues have kept people away from hearing aids,” said Jackie L. Clark, audiologist and professor at the University of Texas at Dallas and past president of the American Academy of Audiology. “It will move that needle closer to recognition.”
Anticipation about what technology may be on the horizon is running high among audiology experts. Braun, best known for its personal grooming products and kitchen appliances, has developed an over-the-counter hearing aid. Braun declined to offer specifics.
“Our product is in development, and we are not ready to share details at this moment,” Deborah Mudway, senior vice president and general manager of Helen of Troy, Braun’s licensed parent company, said in an email.
Sony said last month it will partner with a hearing aid manufacturer to develop an over-the-counter model. Apple has not made any announcements, but its website points to its history of working directly with hearing aid manufacturers to operate hearing aids via smartphone apps. With hearing aids able to stream phone calls and music, the line between ear buds and hearing assist devices is getting blurred.
Amid all the buzz, cost and limited insurance coverage will continue to dampen uptake to a degree, said specialists. Private Medicare Advantage plans offer limited coverage. Only about half of states include some level of hearing aid coverage for their low-income residents through Medicaid.
Because traditional Medicare does not cover any of the costs of hearing aids or audiology services beyond a medical assessment, a $799 set — even if it is cheaper than traditional hearing aids — will still be out of reach for many consumers.
Nimet Adam, an audiologist and development director for Hearing the Call, a nonprofit cooperative of audiologists that provide hearing health care to local communities, said many of the people she works with who can’t afford prescription hearing aids may also not be able to afford over-the-counter devices.
“If it’s $500 to $1,200, that’s going to be an issue for that population,” she said.
Price has historically prevented people from getting hearing aids, said Nicholas Reed, an audiologist and assistant professor in epidemiology at the Johns Hopkins Bloomberg School of Public Health. He has done research finding that from 2011 to 2018, despite an increase in hearing aid use among U.S. adults, there was a 13 percent decrease for those below the poverty line.
He said part of the reason hearing aids became so expensive is the history of the market. When hearing aids first became regulated in the United States, they were analog devices that were difficult to program and potentially dangerous for one’s hearing if done incorrectly, so it made sense to require a professional’s help and implement a gatekeeper model.
However, the market became extremely vertically integrated, he said, with manufacturers owning thousands of hearing aid dispensaries where an audiologist would exclusively offer their products.
“They built a model that essentially is like impossible for a new company to break into,” he said. “Essentially, we had a stagnant market.”
That long-standing state of the marketplace caught the attention of Congress. In 2017, a bipartisan law sponsored by Sen. Elizabeth Warren (D-Mass.) and Sen. Charles E. Grassley (R-Iowa) directed the FDA to develop rules for over-the-counter sales. It took five years for FDA to finish the job.
As more people learn about over-the-counter hearing aids, they will discover a marketplace full of largely unregulated devices that look like hearing aids but are less-sophisticated sound amplifiers. They don’t have to be registered as medical devices with the FDA and most of them should be avoided by people with hearing loss, said experts. Designated as “personal sound amplification products,” they do not call themselves hearing aids or make any health claims to avoid violating FDA rules. And most of them lack key features of hearing aids, such as being able to adjust to specific frequencies of sound.
“Anybody can make anything and call it a hearing booster or whatever. A lot of those are really bad, and they don’t help at all. It’s more noise than anything else,” said Lin, at Johns Hopkins’s Bloomberg School.
After seeking to blunt over-the-counter sales for years, earning the wrath of members of Congress, the trade association representing the “Big Five” global hearing aid manufacturers has declared its support. Asked why GN’s Jabra entered the market with its Enhance Plus hearing aid, Calum MacDougall, Jabra’s senior vice president for marketing, said it makes sense to seek out new customers with mild to moderate hearing problems.
“There are millions of people in the U.S. who have untreated hearing loss,” he said, “and it makes sense for us to help them take their first step.”
Yet Jabra appears to be treading carefully to avoid eroding the traditional GN hearing aid market. Even though Jabra has FDA clearance to market its Enhance Plus as a self-fitting hearing aid under the OTC rules, Jabra avoids calling it a hearing aid in its own consumer website. It uses the term “earbud.”
Asked to clarify, a Jabra spokesman, Claus Fonnesbech, wrote in an email: “The reason is, that in writing, and specifications, the OTC category should not be confused with traditional, prescription-grade hearing aids.”
A previous version of this article described Claus Fonnesbech as a Jabra spokeswoman. Fonnesbech is a company spokesman.