9/19/2022 | By Terri L. Jones

An August 2022 rule from the FDA gives consumers access to over-the-counter (OTC), affordable hearing aids, which will be cheaper than their predecessors and will be available without the cost of audiologist visits. Why does it matter, and what might that mean for you?

Close to 25% of Americans aged 65 to 74 and 50% of those over 75 have hearing loss. This deficit not only keeps seniors from participating in conversations and hearing their favorite television shows, but hearing loss has also been linked to social isolation, depression, and even cognitive decline. However, according to a study published in Archives of Internal Medicine, 86 percent of those over the age of 50 who need hearing aids do not use them.

The stigma attached to these devices keeps many people from using them, but the exorbitant cost and the complicated process to be fitted may be an even bigger deterrent. The process involved testing by an audiologist up front, and then having the hearing aids tuned and rechecked regularly. Worse, there is no way around that time and expense – until now.

Introducing a new category of hearing aids

Because of the magnitude of this as a health problem, Congress passed legislation in 2017 directing the federal Food and Drug Administration (FDA) to create a new category of hearing aids. Over-the-counter (OTC) hearing aids will be much more affordable and they will be available directly from stores or online retailers without the expense of a medical exam or fitting.

This move has been coming for a while, and when President Biden issued an executive order in 2021, the FDA moved forward, finalizing a rule in August 2022 that will make OTC hearing aids available in October. This move will make hearing aids accessible to a greater number of people.

“Hearing loss has a profound impact on daily communication, social interaction and the overall health and quality of life for millions of Americans,” said FDA commissioner, Dr. Robert Califf. “This is a tremendous worldwide problem where I think American ingenuity can make a huge difference.”

Are these new affordable hearing aids right for you?

Happy senior man with hearing aid. Photo by Robert Crum, Dreamstime. A new FDA rule gives consumers access to over-the-counter (OTC), affordable hearing aids, cheaper and available without an audiologist visit.

This new category of hearing aid is designed for those with self-perceived mild to moderate hearing loss. This level of hearing loss ranges from not being able to hear people who are talking softly to having difficulty participating in phone and group conversations or having to turn the television up louder and louder.

One of the advantages of the new OTC hearing aids is that you don’t have to be screened by an audiologist; however, assessing your own hearing isn’t easy. Luckily, there are many online or app-based hearing evaluations, plus some retailers are planning to offer their own screening tests in conjunction with the release of their OTC devices.

If you find that your hearing loss exceeds the mild to moderate level, it’s important to consult an audiologist for a professional screening and hearing aid fitting.

How are these hearing aids different?

Chances are that you may have already seen OTC “hearing aids” out there. Technically, some OTC devices that are currently available aren’t hearing aids at all but “personal sound amplification devices” (PSAPs). These devices generally aren’t as loud, don’t have targeted frequency-range boosts, and are more geared for specific uses, such as birdwatching or suppressing noise in airports and subway stations.

In comparison, the new OTC hearing aids are designed for people with hearing loss. They must be regulated by the FDA as well as meet specific ANSI safety standards. They are also required to have a user-adjustable volume control and include clear, simple user instructions.

What do they cost?

Hearing aids currently cost on average $4,000 per pair, but you could also spend much more (we found one pair going for $14,000!). Unfortunately, you won’t get any help paying for them from Medicare or many insurance plans (unless you purchase an add-on to your plan).

The new OTC hearing aids are no different in terms of insurance coverage; however, it’s less of a factor because of the cost. Experts estimate that they could cost as little as $600 a pair, making them much more feasible for even those on a fixed income.

What if you don’t like them?

Acclimating to hearing aids of any kind can take time and a good deal of adjustment, which you will be doing on your own with OTC hearing aids. With patience, you will eventually become accustomed to the change in sound.

However, if you simply can’t adjust to the hearing aids or they don’t fit your needs, it’s critical that you understand the return policy. If you do decide to return them, be sure to try another OTC pair or seek help from an audiologist. The worst outcome is that you give up and live with declining hearing.

Check out this valuable guide from The New York Times to help you choose the OTC hearing aids that may be right for you.

Terri L. Jones

Terri L. Jones has been writing educational and informative topics for the senior industry for over ten years, and is a frequent and longtime contributor to Seniors Guide.

Terri Jones