Tag Archive: hearables

The first one bites the dust

No longer with us

by Daniel Fink, MD, Chair, The Quiet Coalition

Some observers see great potential in a new category of electronic device called hearables, something a little less than a personal sound amplification device, or PSAP, and certainly less than a hearing aid, but designed to help adults understand conversation in noisy places.

Others of us–and I am in this latter category–don’t see much of a future for these products, which are unlikely to work well and unlikely to be attractive to consumers. After all, who wants to be the only one in the room wearing some silly-looking device?

There are several vendors trying to bring these to market but today we learned that the first one of these, Doppler Labs, bit the dust after burning through $51 million of venture capital.

Its product, Here One, only had a two-hour battery life.

One wishes the $51 million had been spent dealing with the root cause of the problem, making restaurants quieter. That’s what’s really needed to help people with hearing loss.

Dr. Daniel Fink is a leading noise activist based in the Los Angeles area. He serves on the board of the American Tinnitus Association, is the interim chair of Quiet Communities’s Health Advisory Council, and is the founding chair of The Quiet Coalition, an organization of science, health, and legal professionals concerned about the impacts of noise on health, environment, learning, productivity, and quality of life in America.

Researchers confirm cheaper hearables work as well as hearing aids

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

Several Johns Hopkins researchers reported some research in the Journal of the American Medical Association that tested the notion that a cheap ($200-$400) unregulated “hearable” (also known as a personal sound amplification product or PSAP) may be a convenient and inexpensive alternative to a hearing aid.

The researchers tested a handful of the new hearable products just coming on the market and, sure enough, they perform as well as, or nearly as well as, expensive ($2000-$5000 per ear) hearing aids made by the “Big Six.” The Big Six are six companies that have controlled the hearing aid industry; their products are regulated in the U.S. by the Food and Drug Administration.

Recently legislation passed by Congress and signed into law just before the August recess, about which we have written earlier, requires the FDA to de-regulate, i.e. to take a hands-off approach to this new class of high-tech hearing devices. As a result, these new products can be sold over the counter, without a prescription.

Will you need to take them to an audiologist to get them fitted? Certainly you may choose to do so, and that may be the best option, particularly if you are concerned that improper use might endanger your hearing. But with a conventional hearing aid, patients were required to pay professional fees to an audiologist for fittings, etc., resulting in a bundled price that made the hearing aids unobtainable for many people who needed them. You can certainly expect to read articles claiming that these new devices pose a danger. Henceforth, it’s up to the consumer to decide—as he or she already does with regard to many other healthcare products, including over-the-counter drugs that formerly required a doctor’s prescription.

We say caveat emptor (buyer beware), but welcome these new products that cost 1/10th the price of conventional hearing aids. They are suitably priced to be able to meet the needs of 48 million Americans with noise-induced hearing loss, many of whom cannot afford the $4000 to $10,000 price tag for conventional hearing aids. Voters seem to want de-regulation—this is it!

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.

 

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.

iBuds? Apple shows its hand in the “hearables” space

Photo credit: Bjorn Knetsch licensed under CC BY 2.0

By David Sykes, Vice Chair, The Quiet Coalition

This recent piece by Steven Levy in Wired suggests what Apple (and others) are up to in the hearables market. Levy tells us that Apple is collaborating with Cochlear to provide solutions for people with profound hearing loss. This should excite anyone concerned about the epidemic of hearing loss in America, because it suggests that hearing health has gained enough attention that corporate America is applying resources to the problem and turning it into a “technological opportunity.”

If you’ve been following outcomes from the two federal reports last year (from the Presidents Council of Advisers on Science and Technology, and the National Academy of Medicine) and the resulting bi-partisan Over-the-Counter Hearing Aid Act of 2017 (OCHA) approved by the Senate last week (earlier approved by the House), you know something’s up in the hearing health sector. And with the passage of OCHA last week, hearing health, an issue that has languished in the shadows for lack of funding for over three decades is suddenly center-stage again after three decades of neglect.

The Wired article, coupled with the legislative success in the Senate, demonstrate that hearing health is finally starting to get the attention it deserves. That Apple is trying to gain a foothold in this world shows that tech companies smell an opportunity. And the passage of OCHA clearly establishes that hearing loss is a nonpartisan issue important to both republicans and democrats, because despite the state of affairs in DC today it’s an issue on which the nation can begin to make progress even if the rest of the legislative agenda is on hold!

David Sykes chairs/co-chairs four national professional groups in acoustical science: The Acoustics Research Council, ANSI S12 WG44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group. He is also a board member of the American Tinnitus Association, co-founder of the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute, lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), and a contributor to “Technology for a Quieter America” (2011, National Academy of Engineering). 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.

Consumer Reports looks at affordable solutions to hearing loss:

No More Suffering in Silence? Julia Calderone, Consumer Reports, has written a thoughtful piece about hearing loss and the toll it takes on those who suffer from it.  Calderone states that hearing loss “has long been thought of as an inevitable part of getting older, more a nuisance than a life-altering medical condition—at least by those not experiencing it.”  But that opinion is changing, she asserts, as “the President’s Council of Advisors on Science and Technology (PCAST) and the National Academy of Sciences (NAS) have published reports calling untreated hearing loss a significant national health concern­, one that’s associated with other serious health problems, including depression and a decline in memory and concentration.”

Calderone not only treats hearing loss with the seriousness it deserves, she offers solutions to sufferers, particularly those who can’t afford to buy hearing aids, which “cost an average of $4,700 per pair in 2013.”  This is a very steep price, particularly since hearing aids are usually not covered by health insurance or Medicare.  To help with those who need hearing aids but can’t afford them, Calderone reviews a handful of hearing aid alternatives, namely personal sound amplification products (PSAPs), to see if they can fill the gap for those who need hearing aids but can’t afford to buy them.

Two PSAPs not covered in Calderone’s review are also worth considering: Doppler Labs HERE One and Nuheara’s IQbuds.  Neither company markets their PSAPs as a hearing aid or hearing aid substitute, but at around $300 a pair they offer personal amplification and soundscape management to people who might have no other options.

And a final thought about the sorry state of hearing health in the U.S.: For people who are suffering noise-induced hearing loss (NIHL), the personal and economic costs could have been avoided in the first place because NIHL is 100% preventable.

 

Computers in your ears?

Doppler’s Futuristic Earbuds Sound Great. They Also Speak Spanish.  Brian Flaherty, writing for Wired, reviews the newest iteration of the HERE earbuds, HERE One, and pronounces it “one of the wildest gadget experiences I’ve ever had.”  In a good way.  He also is given a glimpse of what is to come, like the ability to have the English translation of a foreign langauge in your ear in real time.  Click the link for more.