Finally, FDA Allows Over-the-Counter Hearing Aids – Commentary

By Devon Herrick

The U.S. Food and Drug Administration (FDA) finally cleared the way for over-the-counter (OTC) hearing aids. Yes, this is a “no-brainer,” and the most obvious question is: Why did it take so long? The law directing the FDA to approve OTC hearing aids was passed five years ago, in August 2017.

Under the new FDA rule announced on August 16, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

Hearing aids are not covered by traditional Medicare, and many people simply choose to do without them because of the cost. Hearing aids that require a prescription cost anywhere from $1,400 at Costco to a multiple of that elsewhere. I recall a relative saying she was quoted $8,000 for a pair, and she was assured they were supposedly better than the cheaper ones.

Officials anticipate OTC hearing aids will save an average of $2,800 off the cost seniors currently pay for audiology testing and legacy devices. The move is not without critics, especially those who benefit from the status quo.

Audiologists Unhappy

The move has rankled some audiologists, the professionals who guide people through the process of choosing the best hearing aid, adjusting the settings, and achieving the right fit. The new move eliminates the longstanding requirement that consumers start with them in getting a hearing aid.

The legislation was initially sponsored by Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA). They issued a joint report in June 2022 alleging the legacy hearing aid manufacturers were engaged in AstroTurf lobbying and otherwise trying to obstruct competition from cheaper OTC hearing aids.

Warren and Grassley identified 19 industry-driven form letters that were submitted in 400 comments to the FDA. That represents 40 percent of the comments received in response to the proposal. That’s to be expected. The industry did not want $250 OTC hearing aids to be of the same quality as the ones costing $1,400 to $8,000 and thus an obviously attractive alternative.

Stuck for Five Years

It’s been nearly five years since President Donald Trump signed into law the Over-the-Counter Hearing Aid Act. The bipartisan bill, introduced by Grassley and Warren, was intended to make hearing amplification devices much cheaper and more readily accessible.

The Act gave the U.S. Food and Drug Administration (FDA) three years to formulate a guidance proposal and an extra six months to collect comments and issue final guidance. Then COVID got in the way. Or was it bureaucratic inertia?

Deadlines Missed

In April of this year, Grassley and Warren introduced a bill to force the FDA to issue its Final Rule within 30 days of the new law taking effect. The Final Rule would clarify the steps and parameters manufacturers are required to follow for OTC hearing aids to become widespread. The FDA had already missed its original three-year deadline in 2020.

To move things along, President Joe Biden issued an Executive Order in July 2021 ordering the FDA to complete the steps to allow hearing aids to be sold over the counter. The FDA eventually proposed a rule in October 2021, but it didn’t issue the Final Rule until August 2022. That’s the second deadline the FDA missed.

You may recall similar delays occurred several years ago when Congress passed, and President Barack Obama signed into law, the Sunscreen Innovation Act of 2014. That law was designed to force the FDA to approve more sunscreen ingredients, most of which had been used safely in Europe for years.

After the bill became law, eight ingredients used in European sunscreens were submitted to the FDA for approval. The FDA rejected all of them. The FDA stated it wanted the industry to conduct extensive, detailed studies before the agency would add these ingredients to the list of items generally recognized as safe. The industry refused to perform these expensive studies because of the cost.

More Than a Money-Saver

According to the FDA, about 30 million Americans experience hearing loss and only one in five seek treatment. Recent studies have identified untreated hearing loss as a contributing factor to dementia, isolation, and depression in seniors.

The FDA’s so-called Final Rule will take effect in 60 days (mid-October), although there are already rudimentary hearing amplification devices on the market. For example, Apple AirPod Pro earbuds can amplify sound in addition to playing music.

The FDA’s Final Rule is expected to encourage bigger, more established electronics manufacturers to enter the market and improve the quality compared to the ones that hit the market early.

Devon Herrick, Ph.D. (devonherrick@sbcglobal.net) is a health care economist. A version of this article was published on The Goodman Institute’s health care blog on August 17. Reprinted with permission.