PUMPING IRONY: A Deafening Silence

As we watch Congress grinding through the sausage-making process of the latest COVID-relief legislation, it’s helpful for impatient citizens to note that our elected representatives are actually moving relatively quickly to provide succor to a pandemic-torn nation. I’m here to tell you that things could be a lot worse: You could be going deaf and waiting in vain for the government to approve the sale of over-the-counter (OTC) hearing aids.

OK, I’m exaggerating. The virus has killed more than a half-million Americans, ruined the lives of countless others, and widened a political and cultural chasm that may take years to bridge. But it does say something about our government’s public-health priorities that three years before the plague descended, Congress instructed the FDA to draft guidelines that would allow hearing-aid manufacturers to sell their products to hearing-impaired geezers like me at our neighborhood drug store without a prescription, without a consultation with an audiologist, and without extracting five grand from our wallets. Four years later, the agency has produced . . . nothing.

This is, I must admit, a little bit personal. I’ve been operating with less-than-optimal audio since the device in my left ear stopped working several months ago. I could bring it into the clinic that sold the original pair to me more than four years ago and find out if they could fix it, but virus paranoia and a sinking feeling that it’s beyond hope (it’s the second device my left ear has somehow rendered inoperable) has kept me from taking any action. It would be so much easier — and cheaper — to simply check out the options at the drug store.

I suspect some portion of the 30 million Americans who share my auditory struggles would also take advantage of such a convenience. Currently, fewer than 16 percent of these hearing-impaired individuals use hearing aids; among those 70 and older, the usage rate is higher (30 percent), but still leaves the vast majority straining to engage in conversation — and raising their risk of dementia and depression.

A recent University of Michigan poll of 2,000 adults aged 50 to 80 found that hearing issues seldom rise to the top of most people’s health concerns. Nearly eight in 10 respondents said they hadn’t had their hearing checked in the past two years. Only 6 percent of these older adults reported using a hearing aid. Cost is a major factor, as Medicare and employer-based insurance plans seldom cover the cost of the devices or the elaborate diagnostic process. Plus, few of us really want to admit we can’t hear very well.

“Having to bear the cost of testing and devices can be a barrier to timely care, on top of the social stigma attached to age-related hearing loss and wearing a device,” says study coauthor Philip Zazove, MD. “These findings spotlight a tremendous opportunity for primary care and audiology clinicians to partner better, and for health-policy decisionmakers to engage on this issue.”

That particular engagement is lagging pretty badly. As Kevin Franck, PhD, and Vinay Rathi, MD, note in the New England Journal of Medicine, OTC hearing aids are already available in other countries, and Congress hoped to spark price reductions and technological innovation in an industry that has been insulated from competition by state licensure laws and corporate consolidation. The bill would essentially encourage manufacturers to make less-expensive hearing aids widely available without forcing consumers to jump through prescriptive hoops.

(To be clear, these OTC devices would be a step up from the less-effective personal sound-amplification products (PSAPs), which are often touted as hearing aids but don’t pass FDA muster.)

But the FDA missed its 2020 deadline, claiming that “competing regulatory priorities” during the pandemic stymied its efforts. And though the agency has declared no clear timeline for releasing the regulations, it did offer some clues to how they might play out by granting Bose Corporation in October 2018 clearance to sell a self-fitted air-conduction hearing aid.

“The indications for this advice,” Franck and Rathi explain, “are identical to those specified by Congress for OTC hearing aids: sound amplification in adults with perceived mild-to-moderate hearing impairment and direct-to-consumer sale for use without a clinician’s assistance.”

You won’t find the Bose device at your local Walgreen’s, though. The company hasn’t yet ramped up production. And, if what it has in mind is anything like the prototype described in the FDA filing, engineers there can take their time because nobody’s going to buy it. The contraption features two large earbuds anchoring a pair of thick wires that descend into a bulky plastic band designed to be worn around your neck. If this is the future of OTC hearing aids, you can count me out.

I may just have to suppress my fear of catching the virus at the sprawling audiology clinic across town and ask them to fix my ailing device. Failing that, I suppose I could spring for a new one. Eighteen months of payments and no interest, if I recall correctly. At that rate, it’s a pretty good bet that I’ll have it paid off well before the FDA gets around to offering me a worse option.