Today the Food and Drug Administration issued a final rule which will give millions of Americans over-the-counter access to hearing aids that heretofore required a prescription. The new rule, scheduled to take effect in mid-October, will benefit as many as 30 million people who suffer from hearing loss.

In 2017 Congress passed, and President Trump signed, the Over-the-Counter Hearing Aid Act as a rider on the FDA Reauthorization Act of 2017. The Act created a new category of OTC hearing aids as devices using air conduction to improve hearing among adults with mild to moderate hearing impairment. It differentiates these devices from devices that amplify sound for people with normal hearing, such as noise-cancelling headphones. The latter are not considered to be hearing aids. Regulations for the new class of OTC hearing aids were originally supposed to be released in 2020 but were delayed due to the COVID-19 pandemic. President Biden issued an executive order on July 9, 2021 that, among other things, prodded the FDA to speed up the rule-making process for OTC hearing aids.

The new rule applies only to persons over age 18 with mild-to-moderate hearing loss. Hearing aids intended for children and for people with severe hearing loss will still require a prescription.

This is welcome news. But it doesn’t go far enough. As Michael Cannon and I explain in Drug Reformation, the FDA has, since at least the 1950s, blocked access to countless life-saving and life-improving medicines and devices by requiring autonomous adults to get permission slips (i.e., prescriptions) from state-licensed gatekeepers, in order to acquire them. This violates their fundamental right to self-medicate. It also tends to inflate the prices of drugs and devices.

As we explain in Drug Reformation:

Evidence suggests that, in addition to the other access barriers they create, prescription requirements correlate with higher drug prices and that removing them correlates with reductions in drug prices…Numerous examples and studies show a correlation between removing prescription requirements and reductions in the price of a drug.

Consequently, the FDA estimates the new rule will save consumers roughly $2,800 for a pair of hearing aids.

Look for competition and consumer choice to further drive down the prices of OTC hearing aids, boosting access to these devices for millions who now go without them. The FDA should next liberate the children, as well as the adults with severe hearing loss.