WASHINGTON — Patricia Holland of Waltham suffered a panic attack during a vacation in Savannah, Ga., 13 years ago when she lost her hearing aid and had no way to quickly find a replacement. Almost two weeks later, when she finally got one, she teared up with joy even though she had to hand over $2,600.
“If you have hearing loss, it’s amazing how people make you feel like you’re inferior,” said the 79-year-old, who first learned she had age-related hearing loss in her 60s. “You’re made to feel that you’re not adequate, when you’re really highly intelligent.”
Now new technology and a rare bipartisan push from lawmakers who are trying to reduce regulations for the sale of hearing aids are raising hopes that more people with mild to moderate hearing loss will be able to buy hearing devices a lot more cheaply and without seeing a doctor.
It’s a modest-sounding goal, but supporters believe the measure on Capitol Hill could lower prices, spur innovation, and ultimately get hearing aids into the ears of far more people. Only 15 to 30 percent of people who need hearing aids actually get them, according to some estimates.
Currently, regulations in most states, including Massachusetts, require consumers to go to a licensed audiologist or other specialist to purchase a hearing aid. The average cost: $2,300.
Legislation sponsored by Democratic Massachusetts Senator Elizabeth Warren and Republican Senator Chuck Grassley of Iowa would supersede individual state rules and force over-the-counter hearing aids into the national market. It has the support of AARP, which is the largest lobbying group for seniors and advocates for people with hearing loss. But it is drawing opposition from hearing aid makers and a major trade association for audiologists.
Supporters say the bill could unleash competition and put hearing aids that cost a few hundred dollars on the shelves. It could also foster technology that, among other benefits, allows consumers to use smartphones to control their hearing aids.
“These new technologies are disrupting the marketplace, to the discomfort of a long-entrenched industry,” said Julie Kearney, vice president of regulatory affairs for the Consumer Technology Association, a major tech trade association that is lobbying for Warren’s bill. “But the technology is here and consumers deserve affordable choices.”
Holland, the Waltham woman with hearing loss, applauded the effort, saying: “To have hearing aids accessible would mean it’s easier and may be more acceptable for people to say, ‘Yes, I could try this. It’s not overly expensive.’ ”
Legacy hearing aid manufacturers and some groups representing audiologists aren’t enthusiastic. They warn it is dangerous to encourage people to self-diagnose hearing loss, which, untreated, can contribute to isolation, depression, and other bad health outcomes. They are skeptical that it will lead to more use of hearing aids.
“We don’t ask them to do that for diabetes or hypertension. We always want to have medical professionals involved,” said Neil DiSarno, chief staff officer of the American Speech-Language-Hearing Association, a trade group for audiologists.
Some 30 million Americans suffer from some type of hearing loss. Other estimates put the figure as high as 48 million. Its prevalence balloons with age: an estimated 45 percent of people ages 70 to 74 years old have hearing loss; more than 80 percent of those ages 85 years and older do.
There’s a web of reasons only a fraction of those people get hearing aids, experts say, including stigma and a confusing landscape of providers and services.
But a big reason is cost: The average hearing aid costs more than $2,300. Most people need two. Medicare and most private insurance won’t cover a dime.
‘The technology is here and consumers deserve affordable choices.’Julie Kearney, Consumer Technology Association vice president of regulatory affairs
Warren’s proposed solution: Have the FDA create a category of hearing aids for people with mild to moderate hearing loss that consumers can purchase from the neighborhood pharmacy or online — much like you can go into the store and buy a pair of nonprescription reading glasses.
About two-thirds of those with hearing loss fall into the mild category, according to the Hearing Industries Association.
Under Warren’s bill, the FDA would regulate the over-the-counter hearing aids, setting performance, safety, and labeling requirements.
“With the right rules in place, safety will be assured, but costs will drop significantly, and that means a lot of people can get help they need,” Warren said.
The idea for her bill came from the recommendations of two scientific panels — the President’s Council of Advisors on Science and Technology in October 2015, followed by an influential National Academies of Science report in June 2016.
At the same time, consumer electronics makers have already started turning out devices to help people hear. Many are sleek, resembling music ear buds. But current FDA regulations mean they can’t be marketed to people with hearing loss, even though some studies have shown some of the better-quality devices perform just as well as approved hearing aids.
In most states, consumers can only buy hearing aids from certified audiologists — professionals trained to test and treat hearing problems — or licensed hearing aid dispensers.
Typically, these practitioners “bundle” the price of the hearing aid — meaning the $2,500 or $3,000 price tag covers not just the hardware but also services from the audiologist to program and tune the device. There’s little transparency, and not every consumer needs the same menu of services.
The six major legacy hearing aid manufacturers have concerns about Warren’s bill, as do some audiologists.
“We’re not flat-out opposed,” said Andy Bopp, executive director of the Hearing Industries Association, a trade group for the manufacturers, though the group’s public statements on the topic are heavy on warnings of the dangers of people self-diagnosing their hearing problems.
Instead, his group is pushing for Warren’s bill to limit over-the-counter devices to just those with mild hearing loss, instead of both mild and moderate loss.
People with mild hearing loss make up “the lion’s share” of the population who don’t address their hearing loss problems, said Bopp. For moderate loss patients, the risks of foregoing professional care are too great, Bopp said.
Bopp rejected the criticism that the manufacturers are afraid of the competition.
“By far the best tech in the hearing space is made by hearing aid manufacturers,” he said.
Grassley said he and Warren believe they can get their bill attached to a must-pass bill reauthorizing user fees that the FDA charges device manufacturers to conduct its safety reviews.
In the House, an unlikely duo of Massachusetts Representative Joe Kennedy III and conservative firebrand Marsha Blackburn of Tennessee introduced companion legislation. Both sit on a key committee that must approve the legislation for it to advance.
“I would like to think this one is not going to be such a heavy lift,” said Kennedy.
The Hearing Loss Association of America, a leading advocacy group for people with hearing loss, supports the bill. So does AARP, which plans to prod its more than 37 million members to reach out to their lawmakers in support.
Consumer electronics manufacturers are lobbying for it as well, including Framingham, Mass.-based Bose Corp., maker of high-end noise-canceling headphones, among other products. Bose has spent several years researching technology to help with hearing problems, but current regulatory barriers don’t make it a viable business prospect for a company that sells its products on Amazon and at Best Buy, said Kevin Franck, head of marketing for Bose’s emerging business unit focused on hearing technology.
“We’ve wanted to make hearing health technology, and the hope is through consumerization, through over-the-counter hearing aids, there could be great ways for us to get involved,” he said.Victoria McGrane can be reached at email@example.com. Follow her on Twitter @vgmac.