FDA Clears Way for Over-the-Counter Hearing Aid Sales

Millions of Americans with hearing loss will soon be able to buy hearing aids from stores and online retailers without seeing a doctor or getting a prescription first.

woman holding a Hearing Aid
Hearing loss is associated with several health problems, such as high blood pressure and heart disease.Kemal Yildirim/iStock

The U.S. Food and Drug Administration (FDA) has approved the sale of over-the-counter hearing aids, a move that may make the devices cheaper and easier to access for millions of Americans.

Consumers with mild to moderate hearing loss will be able to purchase hearing aids at retail stores and online without a medical exam, prescription, or fitting adjustment from an audiologist, the FDA said in an August 16 statement. Hearing aids could be in stores as early as mid-October, the FDA said.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said the FDA's commissioner, Robert M. Califf, MD, in the statement.

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” Dr. Califf said.

A study published in October 2020 put the average out-of-pocket costs for prescription hearing aids at about $2,500, a price too steep for three-quarters of Americans with functional hearing loss to afford.

Under the new regulations, hearing aids will become available without a prescription for people 18 and older. Children and teens with hearing loss, and some adults with severe hearing impairment, will still need prescriptions.

The regulations also call for some safety measures designed to prevent hearing loss or damage to the ear canal, including:

  • Lower maximum sound output to reduce the risk of hearing damage
  • Reduced insertion depth in the ear canal to limit the risk of injury
  • User-adjustable volume controls
  • Instruction manuals that make sense to consumers, not just doctors

Hearing loss is associated with a wide range of health problems, including stress, anxiety, depression, high blood pressure, and heart disease, according to the Centers for Disease Control and Prevention (CDC).

“Decreased hearing ability affects multiple activities of daily living and can have a pervasive impact on quality of life,” says Angela Shoup, PhD, the executive director of the Callier Center for Communication Disorders and a professor of speech, language, and hearing at the University of Texas at Dallas.

“Even people with minimal hearing loss may exhibit increased stress due to difficulty communicating,” says Dr. Shoup, the immediate past president of the American Academy of Audiology.

Close to 30 million adults in the United States could benefit from hearing aids, according to the National Institute on Deafness and Other Communication Disorders (NIDCD). Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others. High costs often keep people from getting hearing aids, the FDA said.

Many people who could benefit from hearing aids have undiagnosed or untreated hearing loss, per the NIDCD. Among adults with hearing loss, fewer than one-third of people 70 and older and fewer than one in six adults 20 to 69 years old get hearing aids.

“The biggest problem with current hearing care is affordability, as hearing aids can be expensive and there may be a lack of awareness of the potential adverse effects of hearing loss and the benefits of hearing care,” says David Loughrey, PhD, a brain health researcher at the University of California in San Francisco and Trinity College Dublin.

“Additionally, adults often delay seeking hearing loss treatment, sometimes for several years, and may find it harder to adjust to hearing aids when they do,” Dr. Loughrey says. “Over-the-counter hearing aids may help address these problems, as most hearing loss in the population is in the mild to moderate range rather than more severe hearing loss where professional care is more necessary.”

There are several telltale signs of mild to moderate hearing loss that might tip you off that it’s time to consider hearing aids, according to the National Institute on Aging (NIA). These include:

  • Difficulty hearing people on the phone
  • Trouble following conversations when two or more people are talking
  • Often asking people to repeat what they’re saying
  • Thinking other people are often mumbling
  • Inability to understand what children are saying
  • Turning up the TV volume so loud that others complain
  • Problems hearing people when there’s a lot of background noise

While there may be cost and access advantages to getting over-the-counter hearing aids, a hearing test by an audiologist is often covered by insurance and may pinpoint the magnitude and type of hearing loss, Shoup says. You may have a better outcome this way than if you go straight to the store to pick out an over-the-counter device, Shoup adds.

“Depending on the type and degree of hearing loss, as well as lifestyle needs, an over-the-counter device may be appropriate,” Shoup says. “However, [a professional] evaluation may reveal that medical intervention, another type of technology, or a more comprehensive hearing treatment plan would be more efficacious.”