[Editor’s note: This story originally was published by Real Clear Health.]
By Jared Whitley
Real Clear Health
Evaluated as “painful” by experts at Purdue University, 120 decibels is somewhere between a jet taking off from an aircraft carrier and Metallica in 1991. This is the kind of sound volume against people protect their ears, not something they try to hear.
So why are for-profit hearing aid companies pushing for it?
That’s the question posed right now to the Federal government. Industry stakeholders, lawmakers, and others are weighing in on how the U.S. Food and Drug Administration’s (FDA) regulates over-the-counter (OTC) hearing aids. As newly proposed FDA rules are currently written, OTC hearing aids would be allowed, by law, to amplify sounds of up to 120 decibels (dB), without a gain limit.
However, during a recent open-comment period held by the FDA, only 20 of the comments submitted agreed that this higher amplification level is okay for users … compared to 1,000 who said otherwise. This mass majority insist we should limit output to a much safer level of 110 dB: that’s still louder than a power-lawn mower or a jackhammer.
So why the dispute?
Well, consumer electronics companies are championing the proposed 120 dB rule as written, because this volume would allow them to “help” more people. The thing is, if someone really needs that much help hearing, they should consult a health care professional and get a prescription – they shouldn’t just be grabbing something from CVS.
OTC hearing aid companies have flooded into the market in recent years. Much like the herbal supplement industry, OTC hearing aids circumvent traditional, more expensive health care channels and empower the consumer. About 44 million Americans suffer from some degree of hearing loss, and many of them want easier access to necessary medical equipment. In theory, having more and cheaper options is good.
However, in the lacuna of appropriate FDA guardrails, misbehavior in a space like this can run amok, harming those who need help. Companies that sell OTC hearing aids have run afoul of the Better Business Bureau, the Federal Trade Commission, and more attorneys general than we can hyperlink.
A hearing aid is a complicated piece of equipment, not a pair of sunglasses. Audiologists don’t just customize hearing aids, but they also look for more severe medical issues, such as otosclerosis and more involved ear pathologies.
But if you’re trying to sell stuff OTC, those traditional health care channels don’t help your bottom line.
This is no doubt why Sen. Elizabeth Warren has been pushing so hard to help the industry. Since 2017, she has been pushing the Over the Counter (OTC) Hearing Aid Act. This opened the door for ordinary retail stores to sell hearing aids in without the guidance of a trained professional, allowing consumers to “take control of their hearing!” Because of COVID, final regulation on this was delayed, leading the Biden Administration to release an executive order last fall directing the FDA to speed up the process for regulating these products.
Warren is doubtless working on behalf of audio manufacturer Bose. Based in Framingham, Massachusetts, Bose is best known for home audio systems and headphones, but has diversified into this space. As chance would have it, right after the FDA’s proposed rule comment period closed in January, Bose started shopping its OTC hearing aid division for a buyer.
When we reached out to Bose, its spokesperson responded, “We’re learning a lot about the hearing aid market and target customer through our experience with this product. This information, along with FDA’s final OTC hearing aid rules, will help inform how we move forward in the category.”
If the FDA sticks to the 120 dB level regulation, Bose Hear is a more desirable acquisition.
It makes sense why Warren – who “has a plan for that!” – would carry water for a company just outside of Boston; it doesn’t make sense why Sen. Chuck Grassley is helping her. The man who’s visited all 99 of Iowa’s counties since the 1980s is renowned for championing conservative causes, but he’s pushing right alongside Warren on this crony capitalism with extra steps.
No one’s quite sure why; hearing aids are probably the last thing in America that doesn’t have corn syrup in it, and maybe Bose has figured out how to fix that.
Health care is expensive and everyone wants to offer cheaper solutions. Snake-oil salesmen have been around as long as people have been sick. OTC hearing aids can be beneficial, but if the line isn’t drawn in the right place, this could hurt more people than it helps. One hopes that isn’t the goal of companies that sell hearing aids.
Jared Whitley is a longtime DC politico, having worked in the US Senate, the White House, and the defense industry. He has an MBA from Hult International Business School in Dubai.
[Editor’s note: This story originally was published by Real Clear Health.]
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