As of Monday, hearing aids are now available over-the-counter (OTC) in the United States, allowing millions of patients with mild-to-moderate hearing loss to purchase hearing aids without a prescription.

Hearing aids available over the counter

In August, FDA finalized a rule making hearing aids available OTC for individuals with mild-to-moderate hearing loss. According to the Hearing Loss Association of America (HLAA), mild-to-moderate hearing loss could include people who have difficulty hearing in groups, on the phone, who need to turn up the TV louder than others, or whose friends and family say they often ask people to repeat themselves and regularly don't understand speech.

Patients are no longer required to undergo a medical exam, obtain a prescription, or be fitted for a device by an audiologist.

Under the final rule, air-conduction hearing aids, which are worn behind or inside the ear, can be sold OTC to adults ages 18 and older. To ensure the safety of the devices, FDA set specific volume limits, as well as certain performance and design requirements.

The OTC hearing aids are also slated to be significantly less expensive than prescription hearing aids. The White House estimated patients could see almost $3,000 in savings when purchasing OTC hearing aids. A pair of prescription devices typically sells for $2,000 to $8,000.

Walgreens has said it intends to sell its Lexie Lumen hearing aids for $799, Walmart and Sam's Club said they'll sell hearing aids starting at $199, and Best Buy will offer almost 20 hearing aids starting at $200.

'This is huge'

The ability to purchase OTC hearing aids means tens of millions of people will now have access to the devices, many of whom may have avoided care because of cost, Kaiser Health News reports.

"From a conceptual point of view, this is huge that this is finally happening," said Frank Lin, director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University. Lin said he thinks it will take a couple of years for manufacturers and retailers to get used to selling hearing aids and for customers to become familiar with the options.

Barbara Kelley, executive director of HLAA, said "When someone finds out they have hearing loss, they often wait five to seven years before they get a hearing aid … So if this would inspire people or motivate people because they see these hearing aids in the mainstream, that should be more affordable or at a different price point, they might take that first step sooner rather than later."

Some audiologists have cautioned that OTC hearing aids won't help patients with severe hearing loss, and Sarah Sydlowski, past president of the American Academy of Audiology, cautioned that over-amplifying sound can cause hearing damage.

However, Nicholas Reed, an audiologist and assistant professor at the Bloomberg School of Public Health at Johns Hopkins, noted that OTC hearing aids are likely less dangerous to hearing than listening to music with earbuds turned up too high, given FDA's safety regulations.

Reed said he recommends patients look for OTC hearing aids that come with generous return policies so customers can try a device for a few weeks, see how it works, and then try another if necessary.

Consumers should also look for hearing aids labeled as "self-fitting," Reed added, because that means companies have proven to FDA that people are able to set up the hearing aids themselves roughly as well as if they had professional help.

"If you are tech savvy, then I say jump right in," said Reed, adding though that "there is nothing wrong with talking to a trained audiologist." (Hernandez/Keck, NPR, 10/17; Gangitano, The Hill, 10/17; O'Connell-Domenech, "Changing America," The Hill, 10/17; Galewitz, Kaiser Health News, 10/17)