Senators Warren, Grassley Call for Allowing Over-the-Counter Sale of Hearing Aids

Senators Elizabeth Warren, D-Massachusetts, and Chuck Grassley, R-Iowa, put their political differences aside to collaborate on a JAMA Internal Medicine Viewpoint article that called for allowing hearing aids to be sold over the counter.

Hearing loss is a widespread issue in the United States, with about half of people age 70 years or older experiencing hearing problems in at least 1 ear, but just 14% of those experiencing this malady use a hearing aid. The senators named a multitude of potential explanations for this underutilization, like social stigma and inadequate screening processes, but identified a solution that they believed could have a powerful impact on access: making hearing aids available without a prescription.

Citing recent recommendations from the President’s Council of Advisors on Science and Technology (PCAST) as well as the National Academies of Sciences, Engineering, and Medicine (NAS), Warren and Grassley contended that making hearing aids available over the counter for mild to moderate hearing loss would be safe and cost-effective. They also referenced a recent announcement from the FDA that it would no longer enforce requirements that individuals receive a medical evaluation or sign a waiver before buying the devices.

Warren and Grassley explained that these events spurred them to introduce the bipartisan Over the Counter Hearing Aid Act of 2016, which would “put PCAST’s and NAS’s recommendations into action, make good on the FDA’s promise, and take important steps to fix a broken market for hearing aids.” Though it was not passed during the last Congressional session, they plan to reintroduce it in the current session.

The senators argued that the current regulation of hearing aids drives up the cost of the devices while constraining consumers’ choices to the products and services offered by their medical provider. Instead, they called for the FDA to create a new regulatory category of over-the-counter hearing aids for adults with mild to moderate hearing loss.

Whereas under the current regulations “people simply lack affordable solutions to help them treat their hearing loss,” the senators wrote, making hearing aids available over the counter would substantially lower their cost and make them more widely available to those in need.

To counter potential objections to the bill, Warren and Grassley pointed to the NAS study, which found no evidence that requiring a medical evaluation before purchase provides any clinical benefit. They also reasoned that individuals are fully capable of diagnosing themselves, as they can identify the effects of hearing loss in their day-to-day lives.

These detrimental effects, they wrote, are among the most compelling reasons to expand access to hearing aids, as the consequences of hearing loss “range from not being able to participate in conversations and difficulty hearing the television or radio, to an increased risk of dementia and falls, social isolation, and depression.”

Concluding the article, Warren and Grassley vowed to continue their battle to make hearing aids more accessible and affordable for the millions of Americans affected by hearing loss, in hopes that Congress and the FDA will listen up.