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How OTC Hearing Aids Will Disrupt an Industry

A dude with a hearing aid listening to purple

The hearing aid industry has enjoyed a captive audience. At any given time, millions of Americans suffer from hearing loss and could benefit from the latest hearing aid technology. But according to recent statistics, only about one in five people with hearing difficulty actually seek such help. Numerous barriers deter them from making an appointment for an audiologist in order to access these devices. But as of mid-October, that will significantly change. With the recent approval of over-the-counter (OTC) hearing aids by the FDA, many of these barriers will no longer exist.

For nearly a decade, professionals and organizations have been lobbying for the FDA to make such a move. In fact, a National Academy’s published report called for OTC hearing aids back in 2016. With the new approval finally, experts anticipate that consumers will not only enjoy many new designs and options for hearing loss treatment. But they will also see a marked decrease in cost, especially now that audiology exams are no longer required. Much to the dismay of the hearing aid industry, OTC hearing aids will result in significant market changes. And that’s a great thing for consumers.

(Dig deeper into Bold’s exploration of hearing loss treatment with this story.)

“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.” – Dr. Robert Califf, F.D.A. Commissioner

A Much-Needed Legislative Change

Reports estimate that roughly 30 million Americans have significant hearing loss with a minority seeking help. One of the big reasons so few choose to get hearing aids involves the actual cost of doing so. Prior to the FDA’s ruling on OTC hearing aids, acquiring a hearing device required being seen by an audiologist. Then, once the exam was complete, one had to be fitted for a specific model to meet their individual needs. Unfortunately, this process resulted in tremendous costs for the consumer than ranged from $1,400 up to nearly $5,000. Understanding that few health insurances cover such costs, price barriers were simply too much for most.

Because many people were being underserved by the current hearing aid industry protocols, lawmakers began calling for change. Organizations lobbied for OTC hearing aids much to the dismay of hearing aid industry representatives. And in 2017, Senator Chuck Grassley and Senator Elizabeth Warren advanced the Over-the-Counter Hearing Aid Act that paved the way. The bipartisan bill eventually became law and allowed the FDA to determine if OTC hearing aids were feasible. After tackling several issues, like federal-state law conflicts and technical hearing aid parameters, the FDA moved forward. Their final rule approving OTC hearing aids will go into effect later this year. And millions will benefit as a result.

“I think our biggest challenge as a profession and as a health care system is to make sure that people understand that hearing is incredibly important. It deserves their attention, it deserves their action.” – Sarah Sydlowski, Associate Chief Improvement Officer of the Cleveland Clinic Head and Neck Institute

Pushback from the Hearing Aid Industry

Perhaps with little surprise, the hearing aid industry has resisted the move toward legal OTC hearing aids. During the public comment portion, the industry submitted a 45-page comment letter opposing the FDA’s decision. Specifically, they claimed that other product-makers would offer low-quality, ineffective, and perhaps even dangerous OTC hearing aids to the public. They also indicated that the lack of professional assessment would result in thousands receiving a poor fit. But these arguments hardly make sense in the light of modern e-commerce. Consumers are more than adept at assessing product quality through product reviews. And hundreds of other OTC devices now exist proving consumers are much savvier than the hearing aid industry thinks.

A closeup of a hearing aid
OTC hearing aids are a game-changer, but for the medical industry and consumers.

In addition to these seemingly invalid claims, the hearing aid industry has also been accused of undermining progress. For one, during the time period for public input, the industry flooded the FDA with negative comments about OTC hearing aids. Lawmakers have also warned the industry may try to dilute the OTC hearing aid market with dozens of low-quality options. In theory, this would push consumers toward professional evaluations and higher-cost products. But in reality, this strategy isn’t likely to be successful. Not only are consumers more knowledgeable and discerning than the hearing aid industry thinks. But many other newcomers to the industry are expected that will force existing players to rethink their approach.

“This could fundamentally change technology. We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.” – Nicholas Reed, Audiologist, Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health

Paving the Way for Innovation

With the introduction of OTC hearing aids, the industry is primed for technological disruption. For too long, old styles and paradigms have prevented the hearing aid industry from advancing. But now that regulations have been removed, all bets are off. Imagine the new designs that will now appear as competition in the marketplace increases. A range of styles at different price points will soon be available to consumers. And naturally, competition overall will drive prices lower and quality higher. Based on these anticipated developments, experts expect millions will finally receive the assistance they need.

Despite hearing aid industry pushback, the FDA approval of OTC hearing aids is a positive step in the right direction. Many people avoid hearing aids because of the stigma associated with wearing existing models. The devices may even lead to age discrimination issues. But new designs have the potential to change this as well. Plus, the FDA’s ruling also will reduce health risks linked to hearing loss. It is well recognized that hearing loss can contribute to cognitive decline, social isolation, and depression. The innovations and options that OTC hearing aids will provide will naturally reduce the occurrence of these conditions as well. If ever there was a market that needed disruption, the hearing aid industry is one of them. And thankfully, the FDA’s approval of OTC hearing aids will achieve just that.


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