Back in August 2017, in a remarkable (these days) bipartisan effort, Congress passed the Food and Drug Administration Reauthorization Act. This act, among other things, ordered the FDA, an agency within the Department of Health and Human Services, to establish a class of hearing aid products that could be purchased without a prescription, in the same manner as, say, toothpaste.
The FDA was given until Aug. 18, 2020, to issue a draft regulation implementing the law. This regulation was to provide reasonable assurances of safety and efficacy; set output limits and labeling requirements; and otherwise establish rules for the in-store, by mail or online sale of over the counter hearing aids. No later than six months after the draft regulation, the FDA was to issue a final regulation. But, it’s now Sept. 12, 2021; no such regulation exists and the FDA, blaming COVID, has seemingly backburnered the project.
This failure by the FDA to carry out a clear congressional mandate, COVID notwithstanding, has ruffled some feathers. Last November, two senators who sponsored the 2017 hearing aid legislation, Elizabeth Warren and Charles Grassley, wrote the then head of the FDA a letter urging him to do what Congress had ordered his agency to do — issue the regulation. The senators said: “Hearing difficulties are associated with depression and dementia and increase the risks of falls in older adults.” And, they added, hearing aids, as prescription-only products, are expensive and generally not covered by health insurance.
Then, on July 9 of this year, the Biden administration issued a wide-ranging executive order instructing all government agencies to get to work creating a competitive marketplace “critical to preserving America’s role as the world’s leading economy.” Included in this executive order was an instruction to the secretary of Health and Human Services to, within 120 days (by Nov. 6), issue the over the counter hearing aid regulation called for in the 2017 law. So we’ll see what happens.
A delay in the availability of over the counter hearing aids is not, of course, a disappointment to everyone. In Colorado and elsewhere, licensed hearing aid providers and audiologists profit from a prescription-only marketplace and may need to adjust their business models when they find themselves competing with the likes of Amazon.
Until over the counter hearing aids are a reality, some people with hearing issues might get help from a “personal sound amplification device.” These are generally low-tech products that work on the same principle as turning up the volume on your television, and they are not allowed to call themselves hearing aids. They can, however, be purchased without a prescription and are much cheaper than actual hearing aids.
In case older readers are wondering about this, notwithstanding diligent research, I have yet to find anything in the law that prohibits hearing aid sellers from learning your age and, after you turn 60, regularly sending you hearing aid marketing materials in unmarked envelopes.
Jim Flynn is with the Colorado Springs firm of Flynn & Wright LLC. You can contact him at email@example.com.