The hearing aid conversation that needs to happen

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“It’s the economy, you idiot!”

Before it became a pop culture reference, this 1992 line from Democratic strategist James Carville was an important reminder to Bill Clinton’s campaign staff: Keep it simple, stick to the facts, and stay focused on what matters.

Thirty years later, hearing aids have become a political punching bag. As in 1992, no one is asking the right questions about hearing health.

In 2017, Congress created a new class of hearing aids for sale in pharmacies for people with perceived mild to moderate hearing loss. Last fall, the Food and Drug Administration released proposed rules for these devices that address everything from sound limits to labeling. During the public comment period that followed, the FDA was overwhelmed with concerns from health organizations, countless hearing care professionals, and nearly every state attorney general. Almost all said, as noted, that these devices could potentially do more harm than good. Until the FDA releases the final rules that will send over-the-counter devices to market, we need to consider how we got here.

The root of the confusion around hearing aids, and the point that needs to be addressed to open up even more access to care, is not the cost; it is skill and care. For three decades, consumer electronics companies have repeated a line: A hearing aid is a consumer electronic device, and manufacturers are overcharging people. These companies think the device is the “solution”, regardless of the role of the hearing care professional. A hearing aid is a piece of the puzzle that must include expert care to ensure patient safety and satisfaction.

Since hearing aids have become part of a political debate, let’s look at the hearing care process as a presidential campaign. Party nomination is like hearing assessment, hearing impairment like a candidate. No two are the same and it takes time to sort out the differences. The assessment determines the type of loss suffered by a person. Then the presidential debates begin. Although choosing a hearing aid is not as controversial as a debate, it is a process. Just as a debate gives clarity to voters, the patient needs to understand how the device can help. A patient’s unique hearing loss and lifestyle are taken into consideration when choosing the device. Everything falls into place on election day. The patient begins to feel results during the fitting, but this is not the last stage. The purchase of this medical device includes professional care for the life of the hearing aid – fittings, follow-up appointments, cleanings and device warranties. The purchase is not the finish line but the starting point.

This bundled approach that includes hearing care professional care is often what Washington overlooks and consumer electronics companies reject. For 30 years, these companies have dipped their toes into the hearing industry, quickly learning that a hearing aid is not a commodity. The idea of ​​offering returns and ongoing service, with wafer-thin margins, drives most businesses to pack their bags. They want to sell a product and move on. They believe that the same business model for headphones and earbuds can be replicated for the sale of a medical device. When hearing health is an integral part of life, the process cannot be so simple.

Since 2014, Bose has said it has a solution, telling consumers and lawmakers that manufacturers are overcharging people. After years of lobbying Congress to create an over-the-counter category, Bose shut down its hearing division just as the FDA is expected to issue OTC regulations. Like Zenith, 3M, Sony, Panasonic, Philips, Bausch and Lomb and Johnson and Johnson, Bose left this industry as quickly as it entered it. There is one element that these companies continue to neglect: care. Patients need more than a do-it-yourself approach to hearing health.

While it’s easy to dismiss the Bose news as a business decision, we have to wonder why that argument is good enough. Bose has changed the hearing industry, and it’s a change I welcome. If OTC hearing aids even help a hard of hearing, that’s a good thing. While I join many professional organizations, state attorneys general, and hearing professionals across the country in their concern about upcoming OTC regulations, I believe that if OTC hearing aids have the proper safeguards to protect patient safety and satisfaction, they could be a valuable addition to the market. However, the simplistic view of “experts” outside the hearing industry cannot confuse, damage the reputation of the hearing aid, or downplay the importance of hearing care professionals.

I hope Bose’s sudden departure will mark a turning point in the conversation around over-the-counter hearing aids – a conversation that should finally focus on the patient, not the profit.

It’s not just a matter of cost; it’s about care. It’s so simple. Hearing is essential, and hearing loss should not be a political slogan. Ignoring the importance of medical device technology and the role of the hearing care professional is not in the best interest of the patient. It’s time for consumer electronics companies and Washington to focus on what matters.

Brandon Sawalich is President and CEO of Starkey, a hearing aid manufacturer based in Eden Prairie. On Twitter: @BrandonSawalich.

About Bradley J. Bridges

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