With a committee vote pending on the Over-the-Counter Hearing Aid Act of 2017, critics of the legislation warn the bill would increase government regulations and raise the cost of personal sound amplification products (PSAPs).
A gun-owner group warned in a letter on Tuesday that language in the act could even tread into Second Amendment rights.
The legislation, led by Sen. Elizabeth Warren (D-Mass.), would create a new category of hearing aids that would be available over the counter. They’re expected to be cheaper than current hearing aids. This sounds good on its face, but the concerns about the act are two-fold: it’s likely to draw people away from proper screenings with health professionals, resulting in poorer health outcomes, and it would create more regulations for PSAPs while preempting state laws.
All devices now sold as hearing aids in the United States are regulated by the Food and Drug Administration and require a doctor’s prescription. Just a few companies sell them and they often cost thousands of dollars, uncovered by insurance. The barrier to entry for consumers led to the growth of PSAPs, which can’t be marketed as hearing aids but are often just as effective for those who don’t suffer severe hearing loss.
Warren’s act tasks the Department of Health and Human Services secretary with redefining PSAPs, likely shifting many of them into the newly created and more heavily regulated over-the-counter hearing aid category.
A letter from a coalition of free-market oriented groups to U.S. Sen. Lamar Alexander (R-Tenn.) chairman of the Senate Health, Education, Labor and Pensions Committee, which signed off on the legislation last week, called the act “a solution in search of a problem that does not exist.”
The House Energy and Commerce Committee is expected to take up the issue Thursday. “It is unfortunate that government regulators and big, rent-seeking corporations are the real beneficiaries of the bill. Consumers are the losers,” the coalition wrote.
Springfield, Virginia-based Gun Owners of America sent a letter to members of the House Energy and Commerce Committee, warning the act could impact a variety of PSAPs that are marketed as hunting aids and intended to help hunters detect the presence of game.
“There’s a pretty good chance that these hunting devices would fall within Warren’s definition of ‘over-the-counter hearing aid,’” wrote Erich Pratt, executive director of the group, “which would mean that a new federal bureaucracy would be in charge of regulating hunting. Were Warren less of an enemy of the Second Amendment, we might give more credibility to the argument that we were protected by the ‘perceived … hearing impairment’ language of the Warren bill. But she isn’t. So we don’t.”
The group asked the committee to remove the language from the bill or put the legislation on hold.
Previously, the free-market coalition said some of the larger companies that produce PSAPs believe they could make more money by selling them as a product on a level with hearing aids, marketing them as such and raising prices. The coalition noted that speaker-maker Bose sells a high-end PSAP called HearPhones, which retails for $500, and is headquartered in Warren’s home state of Massachusetts.
Reason pointed out last week that Bose has spent about $50,000 to lobby for Warren’s act this year, and an additional $100,000 lobbying on “issues related to the FDA” in 2016.
Noah Kraft, CEO and co-founder of Doppler Labs, told TechCrunch his company was working with members of Congress on the legislation. Doppler Labs also makes a high-end PSAP called Here One, which costs $300. The company admitted the legislation would help open up new markets for it.
But even taking the non-cynical view that PSAP manufacturers simply seek the new regulations to put their products on a level playing field with traditional hearing aids creates another concern—taking doctors out of the auditory health equation. Opponents of the bill warn that would leave patients uninformed and undertreated.
The AARP cited a study that found that hearing aids and current over-the-counter options were equally effective for those with mild-to moderate-hearing loss. The biggest difference in user satisfaction was the help of a trained audiologist, who would assist with a proper fitting. But the new legislation would push more people away from, rather than toward, using audiologists.
Many experts within the hearing industry warn that the creation of a category of over-the-counter hearing aids could lead to poorer health outcomes. They warn that consumers who pass on a hearing assessment from an expert could run the risk of not discovering underlying medical conditions.
The Hearing Industries Association released a report on the issue stating that “failure to adequately address hearing loss can have profound negative consequences including an increase in dementia risk.”
Even groups that support the measure, such as the Hearing Loss Association of America, hint at the drawbacks of the regulation by warning people not to forgo doctor visits. “Access to technology or hearing aids by consumers is not a substitute for following good health care practices,” the HLAA said in a press release.
Hearing Tracker conducted a survey on the issue and found that nearly 87 percent of audiologists or hearing instrument specialists oppose the concept. One wrote: “I have seen patients come into my clinic with hearing tests provided by retailers at ‘big box stores’ who should have referred for ENT management and did not. These patients were misdiagnosed (hearing loss was exaggerated to make them hearing aid candidates) and red-flags for medical management were ignored. In one case, patient had a tumor on his auditory nerve. Had these patients not come into my clinic for a second opinion, this dangerous management of their care could have escalated into serious health problems.”
The language of the bill also explicitly removes states’ authority to enforce their own laws regulating over-the-counter hearing aids, although the current approach to auditory health varies state-by-state. Some states allow audiologists to dispense hearing aids, while others do not. Some have continuing education requirements for audiologists.
The coalition argues the act would “empower federal bureaucrats.”
“A new layer of regulation is not a stimulator of innovation – it squashes innovation,” they wrote.
Johnny Kampis is investigative reporter for the Taxpayers Protection Alliance Foundation. Kampis formerly served a similar role at Watchdog.org. Over the course of his nearly 20 years in journalism, he has been published in such outlets as the New York Times, Time, Fox News and The Daily Caller.