New federal law deregulates and disrupts hearing aid market

Photo of Here One wireless smart earbuds courtesy of Doppler Labs

by David M. Sykes, Vice Chair, The Quiet Coalition

Who says this Congress can’t get anything done? Last week huge news appeared for 48 million Americans with hearing disorders, but the media barely noticed::

A new bipartisan law, the “Over-the-Counter Hearing Aid Act of 2017,” will deregulate the hearing aid market, dramatically lowering costs for consumers and releasing a surge of new technologies that will be sold over the counter, without a prescription. Yes, there will be losers as well as winners, but that’s the nature of change….

The new law responds to two federally sponsored reports issued last year (under the Obama Administration). The first report came from the President’s Council of Advisers on Science and Technology. The second was from the National Academy of Medicine. Passed the day before Congress adjourned, the new law creates opportunities for new technology innovators, eliminates the need to get a prescription, and dramatically cuts the cost by allowing substitutes, called “hearables” and “PSAPs” (Personal Sound Amplification Products), to be sold “over the counter.” The goal? a more efficient market that meets the needs of consumers.

As Noah Kraft, co-founder and CEO of Doppler Labs said, “[t]his industry is going to be completely disrupted. The question is by who?”

We have reported about this on several occasions over the past year, but the market disruption is getting underway much sooner that we anticipated thanks to quick action in the House of Representatives and the Senate, action that has emboldened nearly two dozen new entrants to enter the market ahead of schedule.

Who gains? 48 million Americans with incurable noise-induced hearing loss and millions more who are at risk from noise exposure. Who loses? The Big Six  who have dominated the hearing aid market for decades along with approximately 14,000 audiologists, the medical specialists whose services were previously required by the FDA to dispense and “fit” hearing aids to patients. The new Warren-Grassley OTC Act stipulates that the FDA must create a new category for “over-the-counter” hearing assistive devices and let them be sold freely, without intervention.

It’s no secret that the current Congress and the White House crave deregulation. Is deregulation potentially dangerous? Sure, but this is one instance where consumers will clearly benefit. Until now, hearing aids could cost you between $2,500 and $5,000 per ear, so $5,000 to $10,000 total. No wonder so few people have hearing aids—they weren’t covered by insurance or Medicare/Medicaid, so who could afford them? But now prices will drop to 1/10th of that—about $300 to $350 a pair–so lack of insurance coverage is less of a barrier.

We say thanks to the laudable bi-partisan cooperation between Senator Elizabeth Warren (D-MA) and Iowa Senator Chuck Grassley (R-IA) for getting this done at a time when Washington seems mired in dysfunction.

What’s the downside of this deregulatory innovation? There are many unknowns, so caveat emptor (buyer beware) and stay tuned…. But for now, it’s “Hip Hip Hooray”—or should we say, “Hear Here”!

P.S.: Our chair, Daniel Fink, MD, cautions that the real solution to the epidemic of hearing disorders in America is NOT more affordable hearing aids, but rather, a badly needed and long-awaited public health effort to prevent hearing loss—and we wholeheartedly agree with him. Prevention can be encouraged by three means:

  1. Educating people about the dangers of prolonged exposure to noise above 70 dB (permanent hearing damage occurs at levels much lower than currently recognized);
  2. Resurrecting federal efforts to reduce noise (as is being done in Europe and Asia already, where noise is recognized as a public health hazard) from obvious sources like planes, trains, trucks, consumer appliances, construction and outdoor maintenance equipment, etc.; and
  3. Educating companies in industries like aircraft manufacturing, car and truck manufacturing, mining, construction, HVAC, and appliance manufacturing, etc. that noise is harmful to public health.

Prevention can be done: currently, the European Union regulates noise emissions from 50 classes of products. According to Dr. Fink, “a hearable or PSAP is a poor substitute for well-preserved normal hearing; it’s far better to avoid loud noise or to wear earplugs!”

In addition to serving as vice chair of the The Quiet Coalition, David Sykes chairs several professional organizations in acoustical science: The Acoustics Research Council, American National Standards Institute Committee S12, Workgroup 44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group—a partner of the American Hospital Association. He is the lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), a contributor to the National Academy of Engineering report “Technology for a Quieter America,” and to the US-GSA guidance “Sound Matters”, and co-founded the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute. He recently retired from the board of directors of the American Tinnitus Association. A graduate of the University of California/Berkeley with graduate degrees from Cornell University, he is a frequent organizer of and speaker at professional conferences in the U.S., Europe, Asia, and the Middle East.

Comments (4)

  1. Janice

    This is the worst thing to happen to people needing hearing aids. It’s a slap in the face to audiologists and hearing aid providers who spend about 2 years taking advanced theory, practical training and accreditation exams oral and written to be able to fit hearing aids. And the clerk at the store is just going to hand them over? Hearing aids aren’t fit just based on pattern and severity of hearing loss like glasses are fit for severity of vision loss. You don’t just pick up your hearing aids from the receptionist like glasses after they are prescribed and make sure they feel ok on your ears. Hearing aids are computers, with hardware and software including downloadable apps, Bluetooth and Smartphone technology compatibility. Getting hearing aids means a fitting appointment where the aids are programmed for each individual’s specific hearing needs. Severity and pattern of loss, speech distortion, max set below uncomfortable loudness levels, program phone and any assistive listening devices, program sound therapy for hyper ears (tinnitus and hyperacusis), program omni-directional microphone arrays, noise reduction, feedback cancellation, frequency transposition, contralateral routing of signal and anything else the person needs. Eyeglasses are manufactured for seeing. Hearing aids are manufactured and then programmed for best hearing in every environment. Quiet at home. Noisy in a restaurant. Comfortable for outdoor activities like jogging, fishing or golfing. Set best for music. The big 6 international hearing aid manufacturers are big because they have spent decades researching, designing, and manufacturing reliable quality product. Because of bulk sales, their prices are competitive for hearing aid consumers for these high tech digital multi-purpose wearable mini-computers. This is not hip hip hooray. Over the counter will sell iffy product with no custom programming that will only give hearing aids a worse reputation than they unjustly have. I recommend consumers check out the reputable hearing aid market available from hearing loss or hyper ears clinics (e.g. just like picking a car: manufacturers, models, features, prices,) and then make a decision on what to get. So the provider has the specialist knowledge, expertise and advanced accreditation required to personally program the hearing aids for each individual wearer. Because no reputable hearing aid company will sell their hearing aids over the counter retail. People with hearing are now unprotected from cheap product with no guarantee the hearing aid won’t be too loud or sound terrible for them. Buyer beware.

    Reply
    1. GMB (Post author)

      Thank you for your comment. Do-it-yourself over-the-counter hearing aids is not an ideal solution at all, but in the U.S. hearing aids are not covered by Medicare or private insurance companies. For someone who can’t afford the $4000 to $6000 or more to get a pair properly fitted, $300 for a do-it-yourself pair may be the only option. It’s not the same thing as getting a pair fitted by a well-rtrained professional audiologist, of course, but in a for-profit health care system like we have in the U.S., it may be the only option a large swath of people can afford. That said, Bernie Sanders introduced his Medicare for all bill and unlike our current Medicare system, it will cover eyes, ears, and teeth. If Medicare covered hearing aids, things would improve for a significant percentage of the population.

      Reply
  2. Larry

    Why do not health insurance companies cover the hearing loss?

    Reply
    1. GMB (Post author)

      Medicare doesn’t cover hearing aids. The private insurance companies would rather not cover it, I guess, since none of them do. There’s no real competition, so if you can’t afford hearing aids, you’re out of luck. The U.S. has a dysfunctional health care system.

      Reply

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