Back in August 2017, Congress passed the Food and Drug Administration’s Reauthorization Act in a remarkable (these days) bipartisan effort. Among other things, this law instructed the FDA, an agency of the Department of Health, to establish a class of hearing aids that can be bought over the counter, such as toothpaste.
The FDA was given until August 18, 2020 to issue a draft ordinance to implement the law. This regulation should provide adequate guarantees of safety and effectiveness; Set output limits and labeling requirements; and otherwise establish rules for how over-the-counter hearing aids are sold in-store, by mail, or online. The FDA should issue a final ordinance no later than six months after the draft ordinance is drafted. But it is now September 12, 2021; There is no such regulation, and the FDA blaming COVID has apparently left the project behind.
This failure by the FDA to fulfill a clear mandate from Congress despite COVID has disheveled some feathers. Last November, two senators who supported the 2017 hearing aid legislation, Elizabeth Warren and Charles Grassley, then head of the FDA, wrote a letter asking him to do what Congress told his agency – to pass the ordinance . The senators said, “Hearing difficulties are linked to depression and dementia and increase the risk of falls in older adults.” In addition, hearing aids are expensive as prescription products and are usually not covered by health insurance.
Then, on July 9th of that year, the Biden government issued a far-reaching executive order directing all government agencies to get to work to create a competitive marketplace that is “critical to maintaining America’s role as the world’s leading economy ” is. This implementing ordinance contained an instruction to the Secretariat for Health and Social Affairs to issue the ordinance on over-the-counter hearing aids required by the 2017 law within 120 days (by November 6). So we’ll see what happens.
Of course, a delay in the availability of over-the-counter hearing aids doesn’t disappoint. In Colorado and elsewhere, licensed hearing aid manufacturers and audiologists benefit from a prescription marketplace and may need to adjust their business models if they compete with companies like Amazon.
Until over-the-counter hearing aids become a reality, some people with hearing problems may receive help from a “personal sound amplification device”. These are usually low-tech products that work on the same principle as turning up the volume on your TV, and they are not allowed to be called hearing aids. However, they can be purchased without a prescription and are much cheaper than real hearing aids.
In the event that older readers are wondering about this, despite careful research, I have not yet found anything in the law that prohibits hearing aid sellers from knowing your age and informing you after your 60th birthday.
Jim Flynn works for Flynn & Wright LLC in Colorado Springs. You can reach him at firstname.lastname@example.org.