The FDA Approves Over-the-Counter Hearing Aids

On August 17, 2022, the Food and Drug Administration (FDA) authorized the sale of over-the-counter hearing aids. Devices for adults with mild to moderate hearing loss will be available in October 2022. The FDA’s rule follows President Biden’s Executive Order on Promoting Competition in the American Economy, which directed the FDA to take action to make hearing aids available without a prescription.

Posted on September 9, 2022

According to the National Institute on Deafness and Other Communication Disorders, hearing loss affects 30 million people in the United States, many of whom are older adults. Yet, only 25 percent of people with difficulty hearing reach out for physicians’ assistance in obtaining a hearing aid, and less than 30 percent of adults with age-related hearing loss have used a hearing aid.

Signs of hearing loss that suggest a hearing aid may help you include:

• Having trouble understanding people over the phone
• Difficulty hearing whispering
• Mixing up similar words
• Having to hear something more than once to understand it

Although a considerable number of people experience hearing loss, particularly as they age, the cost of hearing aids prevents many from obtaining them. The average price is $2,000 for a single prescription hearing aid and between $4,000 and $6,000 for a pair. Many private insurance policies, as well as Medicare, do not cover the fees.

Retail hearing aids present one solution to the high expense, as individuals with trouble hearing may be able to find more reasonably priced over-the-counter alternatives to prescribed devices.

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The Effect of the Rule

You will now be able to buy over-the-counter hearing aids in stores or online without a prescription from an audiologist or hearing professional.

The devices will be adjustable so that you can control the volume and frequency. However, to prevent hearing aids from causing additional hearing loss, over-the-counter hearing aids will have volume limits. As the devices are for adults with mild to moderate hearing loss, the volume limits make them unsuitable for people with severe hearing loss, who will still need to visit a professional.

The FDA’s authorization will make hearing aids more accessible, and you will be able to buy a hearing aid without consulting your doctor. Note that hearing loss can indicate underlying health conditions, such as chronic kidney disease, diabetes, and cardiovascular disease. If you decide to purchase an over-the-counter hearing aid, speak to your doctor about your concerns.

View the rule by the Food and Drug Administration.