Say hear, hear then, to the federal Food and Drug Administration’s removing the last regulatory block to consumers with mild to moderate hearing loss buying cheaper, easier to access, over-the-counter (OTC) hearing aids — potentially as soon as this fall.
Hearing some fading Bronx cheers? Those may be for the regulators who plodded to potentially benefit tens of millions of folks, who were forking over $5,000 for pairs of medically prescribed devices that previously also required expensive attention of doctors and audiologists. Patients also were ripped for the costs of this care, which typically was not covered by traditional insurance or Medicare. As the Washington Post reported of the regulatory shift to allow OTC hearing devices:
“The FDA’s move follows years of federal efforts to remove obstacles between patients and over-the-counter hearing aids. In 2015, the President’s Council of Advisors on Science and Technology under Barack Obama recommended that the FDA create a new category of ‘basic’ hearing aids that could be purchased without a prescription or a doctor’s visit. Two years later, President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which gave the FDA three years to enact the new rules. The FDA missed that 2020 deadline, but President Biden renewed pressure in July 2021 when he signed an executive order that set a November deadline for a new proposed rule from the federal agency.”
Brian Deese, White House director of the National Economic Council, said easing the FDA’s burdensome hearing aid rules was a “top priority” for the president:
“This is going to make a really concrete difference in the lives of millions of Americans.”
As the New York Times reported:
“The [FDA] cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 or more.”
The devices that makers are expected to market to customers in the days ahead still will not be cheap. They will run from $300 to $500 each, but still will save a user thousands of dollars in comparison to existing offerings, the Washington Post reported:
“The new class of devices will be designed to help people with self-perceived mild to moderate hearing loss, according to Barbara Kelley, executive director of the Hearing Loss Association of America, which has put together a tip sheet to guide consumers who stand to benefit. That includes people who have trouble understanding conversations in groups or on the telephone, as well as those who need to turn up the volume of a television so loud that others complain. ‘This is a first step for people who could do with some hearing enhancement,’ Kelley said. ‘At the moment, 80% of people who could benefit don’t get hearing aids.’ Older adults, who are most likely to have hearing loss and be on fixed incomes, are expected to benefit the most from the change, as are people who live in poor or rural communities with few audiologists.”
Although the few, big existing makers of prescription devices and some specialists resisted the FDA plans for OTC hearing aids, retailers — including electronics dealer Best Buy and big drug store chains — already are gearing up to offer the lower-cost models.
Experts have advice for those eager to take advantage of lower-cost hearing aids, which are expected via competition to drive down costs of all such devices, including those for patients with more significant deficits, the Washington Post reported:
“The [new class] devices will be available for individuals 18 and older at pharmacies, stores and online. Hearing aids often require trial and error, and people often have to adapt to the ones they get. The first device you pick may not be the perfect match, experts said, so check to see whether it has a free trial period or a return policy. ‘Shop around,’ said Kelley, who anticipates that more consumer guidance will be available before the first OTC devices show up on shelves in October.”
Prescription models, as well as specialized care with audiologists, still will be solid options for individuals with significant hearing loss, and patients should not be shy about seeking evaluations of their needs. As the Cochlear Center for Hearing and Public Health at Johns Hopkins has reported on its web site:
“Hearing loss isn’t just an inconvenience that comes with getting older — it’s a critical public health issue that is now the focus of national and international initiatives coming from the National Academies, the White House and the World Health Organization. This global attention to hearing loss is the result of our growing understanding of the impact that hearing loss (present in nearly two-thirds of older adults) can have on the risk of dementia, cognitive decline, greater health care costs, and other adverse outcomes. Implementing strategies to treat hearing loss … could help reduce the risk of these outcomes and optimize the health of older adults.”
In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous products, notably of the costly medical variety.
While it is refreshing to see regulators, for once, move forward some relief to patient-consumers by changing burdensome medical device rules, it is troubling still that the FDA persists in giving corporate manufacturers speedy help with their complaints about what they term agency red tape. Indeed, critics say the agency, instead, is far too lenient in not only letting purportedly innovative medical devices on to public markets but also in letting makers boot-strap regulatory approvals on dubious items through sketchy grandfather-clause allowances.
We have much work to do to ensure that we make the myriad of medical devices like hearing aids safe, affordable, accessible, efficient, and excellent. Taxpayers should watch and listen intently for the FDA to bolster the view that health care is a right not a privilege and special interests cannot be allowed to trump the needs of the public to improve their health and wellbeing.