For years, consumers with mild to moderate hearing loss have had few options for relief. At one end of the spectrum are pricey prescription hearing aids that start at about $1,650 each. At the other end are over-the-counter alternatives, such as personal sound amplifiers (known as PSAPs)—hearing aid lookalikes that range in price from just $20 or $30 to about $350 each.

But PSAPs aren't regulated by the Food and Drug Administration (FDA) for effectiveness and safety as strictly as prescription hearing aids are. And manufacturers of PSAPs are not permitted to call their products hearing aids or to claim that they can help those with hearing issues to hear better. This can be confusing for consumers.

New legislation signed into law late last week, however, might even the playing field for consumers looking for effective and safe options that won’t break the bank.

More on Hearing Loss and Hearing Aids

The legislation, introduced by Sens. Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa, calls for the creation of an entirely new category of hearing aids. These hearing helpers will be sold OTC but will be legally considered hearing aids, and aimed at those with mild to moderate hearing loss.

Like today's PSAPs, they will be cheaper and easier to obtain than prescription aids—but like prescription hearing aids, will be more tightly regulated by the government.

This is good news, according to Consumers Union, the mobilization and policy arm of Consumer Reports. "This law will help ensure that consumers with mild to moderate hearing loss have easily accessible, affordable options for hearing devices," says George Slover, a senior policy counsel at Consumers Union. 

Some professional organizations agree. James C. Denneny III, M.D., CEO of the American Academy of Otolaryngology—Head and Neck Surgery, says the new law will help consumers who otherwise would not have sought help for hearing problems because of the high cost of aids or the stigma attached to them. “The overall concept of expanding the market and making hearing aids more affordable to consumers has huge appeal," he notes.

But not everyone believes over-the-counter hearing aids will be an all-out win for consumers. The American Speech-Language Hearing Association, an industry group, maintains that while this new category of aids will help some people with mild losses, "the best approach for consumers to address hearing loss is to seek the services of a licensed and certified audiologist,” says Jaynee A. Handelsman, Ph.D., ASHA’s past president and director of pediatric audiology at Michigan Medicine at the University of Michigan.

In fact, a recent statement from ASHA notes its concern that "people who experience greater than a mild degree of hearing loss could take the misguided step of trying to seek relief via OTC solutions.”

If you're interested in trying a FDA-regulated, over-the-counter hearing aid, you won’t be able to do so just yet. The FDA has three years to come up with rules for which products will fall into this new category, what their technical specs must be, and how they’ll be labeled and marketed.

Here, what you need to know about this law, the potential pros and cons of over-the-counter hearing aids, and—since it may be several years until we see these new products on the market—how to navigate the OTC options that are currently available.

What Will OTC Hearing Aids Look Like?

Currently, it’s not known exactly what kinds of devices will fall into the new category of over-the-counter hearing aids. Kim Cavitt, Au.D., an audiologist and adjunct lecturer at Northwestern University, predicts we may see products such as multifunction earphones with amplification options and some lower-end prescription aids currently available by mail order and online move to the new OTC hearing aid category.

She expects a number of PSAPs—but not all—will also be included. “I think some current PSAP manufacturers, whose products are truly intended to assist the hearing impaired, will want to be included in the new OTC hearing aid category if they can accomplish the technical, manufacturing, and marketing standards and regulations,” Cavitt says.

As for cost, Denneny foresees a wide range of price tags, depending on the sophistication of features offered. (More-expensive prescription hearing aids, for instance, tend to have Bluetooth and music streaming capabilities.) But he thinks that even high-end OTC hearing aids will be significantly cheaper than most prescription aids—potentially costing less than $1,000 or even $500 each.

Pros and Cons of OTC Hearing Aids

Who may get the most out of this new category of hearing aids? If you have mild to moderate hearing loss—difficulty deciphering a whisper or low conversation, or trouble keeping up with conversations in a noisy restaurant, for example—OTC hearing aids may be a great “starter device,” says Cavitt.

Those with more severe loss likely won’t benefit, in part because they may need more customization and amplification in specific ranges than an OTC hearing aid offering may be able to provide.

They may also be better off working with an audiologist (a hearing professional who typically has a doctoral degree) or other certified hearing specialist (who provides similar services but has less training), who can make sure any aid is fitted and adjusted correctly. Currently, this service and a number of others, are often bundled into the cost of prescription hearing aids. Audiologists may ultimately provide this for OTC hearing aids, but that remains to be seen, says Denneny.

And, Denneny cautions, you may not be able to return an over-the-counter hearing aid if you don’t like it—as you usually can with prescription aids. Additionally, if your hearing loss is due to another medical problem, such as impacted earwax or a perforated eardrum, a hearing aid, whether prescription or OTC, isn’t the right treatment.

What You Can Do Now

If you suspect you're not hearing as well as you should, a professional hearing test can help pinpoint the cause and severity.

If your loss is mild to moderate, and you want to consider an OTC device, you might try a PSAP to see whether it helps. Consumer Reports recently tested four PSAPs: the Sound World Solutions CS50+ ($350), Etymotic BEAN ($399 for a pair), Bell & Howell Silver Sonic XL ($20), and MSA 30X ($30).

We found the Sound World Solutions CS50+ and the Etymotic BEAN outperformed the others, especially for TV-watching. These two PSAPs did well in a recent JAMA study, too.

We found that the two cheaper models, however, provided little benefit and even had the potential to cause further hearing damage. (Get the details on our PSAP testing here.)

As with a prescription hearing aid, the effectiveness of a PSAP can vary, depending on your particular hearing needs and the product you choose. So in addition to that professional hearing test, say our experts, consider asking an audiologist, hearing aid specialist, or otolaryngologist (an ear, nose, and throat doctor) for guidance.