Hearing activists and Americans with hearing loss alike were undoubtedly popping champagne corks in celebratory glee on August 18, 2017, when President Donald Trump signed S 934, the Reauthorization Act of 2017. Section 711 of the new law directed the Food and Drug Administration to create a category of over-the-counter hearing aids for adults with mild-to-moderate hearing loss. To give the new law at least the appearance of teeth, the FDA was further directed to issue a proposed rule three years hence, or by August of 2020. This new law is important because, unlike unregulated personal sound amplification products, or PSAPs, hearing aids are considered to be medical devices and must be approved by the FDA to be sold as hearing aids. PSAPs, which are unregulated, provide simple sound amplification without the auditory nuances of regulated hearing aids sold by audiologists, otolaryngologists (more commonly known as ear, nose, and throat docs), or hearing-aid specialists. Third parties, sensing the looming mother load, are chomping at the bit at the starting gate, poised to leap into the marketing fray to claim a slice of the lucrative OTC pie.
August of 2017 has long come and gone. So why the FDA delay, despite the law’s timeline? The FDA blames COVID, the new de facto excuse for incompetence by laggards everywhere. How a group of FDA bureaucrats, presumably working fulltime from home during the pandemic lockdown, dropped the ball in their mandate to finalize those OTC hearing aid regulations already two years in the making when the lockdown began, is an open question. Zoom, anyone? Two calls to the FDA’s media affairs office, after a tedious, several-minute voicemail about how to call somebody else with your questions, went unanswered. I’m beginning to doubt that anyone works there.
So the wait continues for OTC hearing aids, which are expected to cost a fraction of what tightly regulated hearing aids cost today. Asking what hearing aids cost is like asking the price of a dress: they’re all over the map. What they have in common is that they’re all expensive, anywhere from around $1,500 to close to $10,000, and that’s per ear. Adding insult to injury virtually no insurance covers them, including Medicare, which covers the seniors who need them most. When Medicare was enacted back in 1965 hearing aids were deemed “routinely needed and low in cost.” The ‘routinely needed” part is still true enough though according to an article on mdhearingaid.com only 20 to 30 percent of adults who could benefit from a hearing aid ever get one.
Ukiah audiologist Glynis Tambornini, who has practiced in her Mendocino-Lake Audiology clinic since the 1990s, told me that the impenetrable Medicare wall is nothing new.
“Medicare has been a battle since I have been an audiologist back in the ‘90s,” she said. “We’ve tried to get small reimbursements for our patients but [hearing aids] aren’t covered.”
In fact, even if for some medical reason Medicare Part B covers a hearing exam you still have to pay your Part B deductible and 20% of the Medicare-approved amount for the doctor’s services. There are a few exceptions in some Medicare Advantage plans, but read the fine print before you take out your checkbook.
In one of my brief stop-gap jobs before I could collect Social Security I helped out a neighbor part time in her audiology office. She told her patients that buying hearing aids at Costco was akin to undergoing brain surgery at your local veterinary hospital. She touted the existential role of audiologists with messianic fervor. She also had a separate computer system for her finances that even her office manager couldn’t access, probably for good reason since, according to Consumer Reports, the average retail markup on hearing aids is a whopping 117%.
Though I didn’t find credible evidence that audiologists, as a group, have played a role in the FDA’s long delay in developing regulations for much-cheaper OTC hearing aids, I have my suspicions. Like all professions, audiologists have good reason for protecting their turf. According to salary.com, as of May of this year an audiologist in California earns an average annual salary of $95,377, an elastic figure dependent on many factors, including his or her markup over the wholesale price of hearing aids.
Tamborini said that it’s the nature of tech to strive to be better and cheaper.
“OTC hearing aids have a place, just like reading glasses,” she said, adding that despite the obvious comparison glasses are less complicated than hearing aids. “You don’t hear with your ears, you hear with your brain, which in a person with normal hearing provides a good filter in noisy environments. She said that determining a person’s hearing needs depends upon that person’s individual environment and need. “Nobody needs a [volume] gain in a noisy environment,” she said, adding that some patients need to hear better in group conversations than in one-on-one conversations and vice versa. Everybody’s different.
I remember the exact time and place when I realized I needed hearing aids. I was covering a city council meeting in Ferndale, in Humboldt County, for the local paper there. The council members, all men, met in the ancient town hall building up on a stage at the front of the room. Midway into their regular meeting I realized that I couldn’t hear well enough to write the story. Unlike most people with hearing loss who have trouble hearing high-pitched sounds, I couldn’t hear low sounds. It was much harder for me to understand men’s voices than women’s voices. It was (and is) a problem of tone, not amplification.
Tambornini told me that her patients are getting younger, a problem likely traced to the use of high-volume headphones. She added that younger patients have also lessened the stigma of wearing hearing aids since headphones, Bluetooth, ear buds and the like have become commonplace. Hearing devices that used to say “old” have now become cool in their resemblance to other high-tech listening devices.
So, for now, the FDA’s failure to develop regulations for OTC hearing aids could kick back their availability to mid-2022 given the agency’s multi-step process of a 60-day public comment period followed by an additional 180 days for FDA review in addition to other steps and ample “twiddle their thumbs” time in between. But the big guns are waiting in the wings, chomping at the bit, one already poised to cash in its stake in the vast Walmart market. If it’s like the Costco model, where I bought my last hearing aids, you’ll be able to self-test your hearing (though an audiology tech tests your hearing at Costco), buy hearing aids, and come back for service, all for a few hundred bucks instead of a few thousand. Where there’s money to be made, especially a lot of money, if recent history has taught us anything, it’s that the market is ultimately unstoppable, despite whatever roadblocks are thrown in its path. We’ll see.