“It’s the economy, idiot!”
Before it became a pop culture reference, that 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’s important.
Thirty years later, hearing aids have become a political punching bag. As in 1992, no one is asking the right questions about hearing care.
In 2017, Congress created a new class of hearing aids that will be sold in drugstores for people with mild to moderate hearing loss. Last fall, the Food and Drug Administration released proposed rules for these devices that cover everything from noise limits to labeling. In the public comment period that followed, the FDA was inundated with concerns from health organizations, countless hearing care professionals and nearly every state attorney general. Almost everyone said, as outlined, that these devices could potentially do more harm than good. While we wait for the FDA to release the final rules marketing over-the-counter devices, let’s see how we got here.
The root of the confusion around hearing aids, and the point that needs to be addressed to bring even more open access to care, isn’t cost; to be expertise and concern† For three decades now, consumer electronics companies have been repeating one rule: a hearing aid is a consumer electronics device and manufacturers overcharge people. These companies think that the device is the “solution”, without considering 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.
As hearing aids have become part of a political debate, let’s think of the hearing care process as a presidential campaign. The party nomination is like the hearing evaluation, hearing loss like a candidate. No two are the same, and it takes time to sort out the differences. The evaluation determines the type of loss a person has. Then the presidential debates begin. While choosing a hearing aid isn’t as controversial as a debate, it is a process. Just as a debate provides clarity to voters, the patient must understand how the device can help. A patient’s unique hearing loss and lifestyle play a role in the choice of device. Everything comes together on voting day. The patient begins to experience results during the fitting, but it is not the last step. The purchase of this medical device includes professional care for the life of the hearing aid – the fittings, follow-up appointments, cleanings and device warranties. The purchase is not the finish line but the starting point.
This unified approach that encompasses the care of the hearing care professional is often what Washington overlooks and what consumer electronics companies reject. For 30 years, these companies have dipped their toes into the hearing industry and quickly learned that a hearing aid is not a commodity. The thought of offering returns and continuous service, with wafer-thin margins, makes most companies pack their stores. 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 essential part of life, the process can’t be that simple.
Since 2014, Bose has said it has a fix, telling consumers and lawmakers that manufacturers were charging people too much. After years of lobbying Congress to create an over-the-counter category, Bose closes its hearing department just as the FDA is expected to release 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 still overlook: care. Patients need more than a DIY approach to healthy hearing.
While it’s easy to dismiss the Bose news as a business decision, we have to ask why that argument is good enough. Bose has changed the hearing industry, and I welcome that change. If OTC hearing aids even help a person with hearing loss, that’s a good thing. While I join many professional organizations† state attorneys general and hearing care professionals across the country in their concerns about upcoming OTC regulations, I believe that if OTC hearing aids have the right guardrails 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 should not cause confusion, damage the reputation of the hearing aid or underestimate the importance of hearing professionals.
I hope Bose’s sudden departure is a turning point for the conversation about OTC hearing aids – a conversation that should finally focus on the patient, not profit.
It’s not just about cost; it’s about care. It’s that simple. Hearing is essential and hearing loss should not be a political punchline. 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.