Hearing aids are moving to retail with lower costs and easier access.

The government will start allowing pharmacies and big-box stores to sell hearing aids without a prescription on Monday. and stifling creativity.

Supporters of the change say over-the-counter hearing aid sales will bring lower prices and revolutionize new technologies, expanding access to millions of people with untreated hearing loss.

But while the transition promises to improve the lives of millions of people with mild-to-moderate hearing loss, consumer-driven healthcare also poses a broader challenge.

Hearing aids require fine tuning and some patience, audiologists say, as first-time users’ brains get used to producing sounds that have been suppressed for years. Popping on a new pair of glasses and it’s not immediately obvious. It sometimes takes days or weeks to get used to them, which may be easier for the tech-savvy but more challenging for the older target audience.

Manufacturers say they are ready to simplify the process for new customers. Today’s hearing aids come with smartphone apps that allow consumers to adjust the devices themselves. The manufacturers are also setting up call centers and help desks to help their customers with troubleshooting and troubleshooting.

What’s more, millions of new customers are on the horizon, representing billions of dollars in sales, gearing up to compete on price, sound quality, design, and features 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 the Johns Hopkins Bloomberg School of Public Health. “There’s a lot of market opportunity here. It’s never been done this way.”

The significant learning curve will be significant marketing. Consumers, unnecessarily giving more options See a doctor, advocates say. The Food and Drug Administration has limited the retail, non-prescription sale of devices designed for people 18 and older with mild to moderate hearing loss.

Megan P., director of audiology at Massachusetts Eye & Ear. “The potential benefits outweigh the complexity of learning how to navigate,” said Reed, MD, a Harvard-affiliated medical and research hospital. With low cost and easy access, she says, “it could force some changes in the hearing aid industry.”

However, most medical insurance plans, including traditional government Medicare for seniors, do not cover hearing aids or visits to improve hearing, which continues to limit access for many people, Reed said.

Two early adopters that have entered retail sales are Lexi and Jabra, which sell over-the-counter devices for $799 a pair. Some prescription hearing aids sell for around $2,000 a pair, typically with audio services, which often bring the total price to $4,000 to $8,000.

The devices are available in 11,000 retail stores, including Walgreens, Walmart and Best Buy, a Lexi executive said in an interview. Jabra — part of the GN Group, the Danish company that owns Resound, one of the top five traditional hearing aid manufacturers — said the combined streaming headphones and hearing aid will be in 300 Best Buy stores starting Oct. 24.

Lexi hearing aids, made using Bose technology, are sold behind the pharmacy counter, Walgreens said. Buyers are directed to Lexi’s website, which has online hearing tests and help desk contacts, the company said. In addition to sound quality and design, Lexi said it plans to compete on the quality of its customer service and app usability.

“Traditional hearing aid players have dominated the pie for the past two decades, and it remains to be seen how big the category will grow,” said Celine van der Waat, chief operating officer for Lexie’s Southern division. Africa-based Ear X Group. By selling directly to people with mild to moderate hearing loss, over-the-counter sales “create a whole new pie,” she added.

Lexie’s Instagram marketing account, hearingwithlexie, offers $42-per-month payment plans and certifications. One of them set high expectations: “It worked great out of the box. I’ll hear it again,” said Kenneth D., a smiling man with a white beard who spoke as he pressed the instrument to his ear.

Along with some high-cost cancer drugs and other pharmaceutical drugs, as well as some durable medical equipment, $800 hearing aids are among the top-selling items at Walgreens stores. The drugstore chain believes the epidemic has proven — through the use of faster tests and greater reliance on telehealth, for example — that consumers are ready to handle more medical needs with more freedom, said Luke Rauch, Walgreens senior vice president and chief merchandising officer. .

“Health care is going home. “Anything we can do to accelerate and enable that pivot, so that healthcare is uber-localized and you can do it from the comfort of your own home, that’s the bull’s eye of our mission,” Rauch said.

CVS said it will have the hearing aids in its stores in November and will begin online sales this week, without giving specifics.

Hearing specialists are thrilled that more people with untreated hearing loss are getting access to critical equipment. Untreated hearing loss can lead to cognitive decline, isolation and dementia, but only a fraction of the 28.8 million people who use hearing aids use them, according to the National Institute on Hearing Impairment and Other Communication Disorders. Only 16 percent of adults under the age of 69 and 30 percent of those over 70 are eligible, the agency said.

Research shows that it can take up to seven years from the time a person is first diagnosed with hearing loss to purchasing a hearing aid. Cost and negative stigma are often the biggest factors, experts say, and over-the-counter sales can ease those consumer concerns.

Jackie L., an audiologist and professor at the University of Texas at Dallas and former president of the American Academy of Audiology. “It makes this injection closer to recognition.”

Speculation is high among audiologists about what technology might be on the horizon. Brown, known for personal grooming products and kitchen appliances, has developed an over-the-counter hearing aid. Brown declined to provide specifics.

“Our product is a work in progress, and we’re not ready to share details at this time,” said Deborah Mudway, senior vice president and general manager of Braun’s licensed parent company, Troy Helen.

Sony said last month that it was partnering with a hearing aid manufacturer to make an over-the-counter model. Apple hasn’t made any announcements, but its website points to its history of working directly with hearing aid manufacturers to make hearing aids compatible with smartphone apps. While hearing aids can stream phone calls and music, the line between headphones and hearing aids is blurring.

With all the noise, expense and Limited insurance coverage will continue to weaken the rate to a degree, specialists said. Private Medicare Advantage plans offer limited coverage. Only about half of states include some level of hearing coverage for their low-income residents through Medicaid.

Because traditional Medicare doesn’t cover any costs for hearing aids or audiology services beyond a medical evaluation, the $799 set — although cheaper than traditional hearing aids — is still out of reach for many consumers.

Nimet Adam, audiologist and director of development at Calling Hearing, a nonprofit audiologists’ cooperative that provides hearing health services to local communities, said many of the people she works with may not be able to afford prescription hearing aids. Over the counter tools.

“If it’s $500 to $1,200, that’s going to be an issue for that population,” she said.

Nicholas Reed, an audiologist and assistant professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, said that people have historically been unable to access hearing aids. In the year From 2011 to 2018, hearing aid use among US adults increased, but there was a 13 percent decrease among those below the poverty line, the study found.

He said one of the reasons hearing aids are expensive is the history of the market. When hearing aids were first regulated in the United States, it was appropriate to seek professional help and implement a gatekeeper model because they were analog devices that were difficult to model and could be dangerous to a person’s hearing if improperly used.

However, the market has become highly integrated, with thousands of hearing aid manufacturers offering their products, audiologists say.

“They built a model that was almost impossible for a new company to break,” he said. “Essentially, we had a stagnant market.”

That long-term market situation has caught the attention of Congress. In the year In 2017, bipartisan legislation sponsored by Sen. Elizabeth Warren (D-Mass.) and Sen. Charles E. Grassley (R-Iowa) directed the FDA to develop regulations for over-the-counter sales. It took five years for the FDA to complete its work.

As more people learn about over-the-counter hearing aids, they find a marketplace full of unregulated devices that look like hearing aids but are less complicated. They do not need to be registered with the FDA as medical devices and should be avoided by most people with hearing loss, experts say. Labeled as “personal loudspeaker products,” they do not call themselves hearing aids or make any health claims to avoid violating FDA regulations. And most hearing aids lack key features, such as the ability to tune out certain audio frequencies.

“Anyone can do anything and call it auditory or whatever. A lot of it is really bad, and it doesn’t help. It’s more noise than anything else,” said Lynn at the Johns Hopkins Bloomberg School of Public Health.

The “Big Five,” the global trade association representing hearing aid manufacturers, announced its support after years of seeking to decriminalize over-the-counter sales, drawing the ire of members of Congress. Asked why GN Jabra entered the market with the Enhance Plus hearing aid, Jabra Senior Vice President of Marketing Calum McDougall said it was appropriate to target new customers with mild to moderate hearing loss.

“There are millions of people in the United States with untreated hearing loss, and it’s worth helping them take that first step,” he said.

However, Gebra seems to be treading carefully so as not to erode the traditional GN hearing aid market. Although Jabra has FDA approval to market Enhance Plus as a self-fitting hearing aid under OTC regulations, Jabra refrains from naming the hearing aid on its own consumer website. He uses the term “earphone”.

Asked for clarification, Jabra spokesman Klaus Fonsebeich wrote in an email: “Because of the text and specifications, the OTC category should not be confused with traditional, prescription-grade hearing aids.

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