U.S. Senators Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.) and Johnny Isakson (R-Ga.), reintroduced legislation to make hearing aids for those with mild to moderate hearing loss available over the counter (OTC). A companion bill led by Representatives Joe Kennedy III (D-Mass.) and Marsha Blackburn (R-Tenn.) was also introduced in the House of Representatives.
At an April 13th town hall meeting in Salem, Mass., Warren insisted that the host of health and social challenges people with hearing loss experience due to a lack of access to affordable hearing aids “is a problem we can fix” with regulatory reform because the technology is there.
The Over-the-Counter Hearing Aid Act of 2017 would make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment. In addition, the proposed legislation would require the U.S. Food & Drug Administration to write regulations ensuring that this new category of OTC hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as all medical devices, providing consumers the option of an FDA-regulated device at lower cost.
Millions Go Without Due to Costs
Nearly 30 million Americans experience age-related hearing loss, including over half of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss -- around 14 percent -- use hearing aids, primarily due to their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 - far out of reach for many consumers.
“Allowing hearing aids to be sold over the counter will help bring down costs and expand consumer choices so that millions more Americans can find affordable hearing aids,” Senator Warren said. “This bill will loosen up outdated regulations and, with the right protections in place, let the market bring great products to Massachusetts residents at far lower costs.”
“I hear from Iowans about the high cost of hearing aids, and I understand the concern,” Senator Chuck Grassley said. “If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. More consumer choice and convenience are what we want to accomplish with this legislation. This won’t affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted. The over-the-counter option is for those who would benefit from a simpler device.”
The American Association of Retired People indicates that hearing aid prices range from $1,200 to $3,500, but since 80 percent of wearers need two, costs run up to $7,000.
Why Is There No Lower Cost Solution?
In a post for the Journal of the American Medical Association, Warren and Grassley addressed several factors that make hearing aids inaccessible to many adults with hearing loss.
“First, hearing aids are expensive, and Medicare and most private insurance plans do not cover the cost. Out-of-pocket costs for a single device average more than $2,000, and individuals with hearing loss in both ears may require two hearing aids to properly treat their condition. These costs are simply too high for many people to afford, so instead they go without treatment for their hearing loss,” the senators wrote.
They also discussed service fees and current audiology practices that can limit product offerings based on incentives for retailer.
Dispensers may then use proprietary software to tune the hearing aids, locking consumers in to coming back to the same retailer for any follow-up adjustments,” according to JAMA.
The American Journal of Public Health also recently published Opening the Market for Lower Cost Hearing Aids where the physician authors discuss how regulatory changes can improve the health of older Americans. Only one in seven American adults that need a hearing aid use one, they said, and it’s a 30-year trend.
Prices haven’t dropped, “despite trends of steady improvements and price reductions in the consumer electronics industry,” wrote Jan Blustein, MD, PhD and Barbara E. Weinstein, PhD in the abstract.
Read the original legislative announcement on Senator Warren’s website.
