When Congress passed the Over-the-Counter (OTC) Hearing Aid Act in 2017, it opened up a new world of possibility for people with hearing loss. Instead of paying $5,000 for a pair of FDA-approved hearing aids and follow-up service, you could pay hundreds of dollars for an OTC pair from any seller — no doctor appointments, hearing tests, or fittings needed. The devices would have the same fundamental technology as traditional hearing aids, they’d be targeted to people with perceived mild-to-moderate hearing loss, and the FDA would ensure quality by regulating and approving the OTC devices. (See NOTE, below)

But almost four years later, the OTC hearing aid category and its safety and labeling rules are still tied up in red tape.

That doesn’t mean the gadgets don’t exist; they’re available online and in some stores or health care practices. But the devices are unregulated and unapproved, and you need to carefully navigate this category of hearing devices since you can’t always be sure what kind of quality you’re getting.

What are the gadgets?

Until the FDA creates a new OTC category, any sound amplifier that’s not an FDA-approved prescription hearing aid is considered a “personal sound amplification product” (PSAP).

The FDA says PSAPs are appropriate only for people with normal hearing who want to boost sounds in certain situations, such as bird watching or listening to lecturers. And initially, that’s about all PSAPs were good for. They were clunky over-the-ear sound amplifiers with short battery lives and minimal features. They had a one-size-fits-all setting and couldn’t remove unwanted sounds.

Those problems are largely gone, as technology has evolved. Like the more expensive hearing aids, many PSAPs are small devices placed inside your ear. You can customize settings for your needs and usually modify them using a smartphone. “PSAPs aren’t allowed to be called hearing aids, but in some cases the technical differences are very subtle,” says Kevin Franck, until recently the director of audiology at Harvard-affiliated Massachusetts Eye and Ear.

What’s the catch?

Skipping a hearing test and simply buying a pair of PSAPs comes with certain risks. For example: “Without a hearing test, you won’t know what’s causing your hearing problem. It could be wax buildup or in rare cases a tumor. And not all types of hearing problems are solved by amplification,” Franck says.

Other potential problems:

• Some PSAPs promise helpful features but are poor quality and nonreturnable.
• High-tech PSAPs may be hard to use, controlled by complicated smartphone apps.

Important features

Despite these caveats, some clinicians consider PSAPs solid alternatives for people with mild-to-moderate hearing loss, as long as you know what to look for. Franck suggests PSAPs with easy-to-use controls and apps, customer service to help you figure out how to operate the devices, and a money-back guarantee with a 60-day return window.

Other features Franck recommends:

Customization. Make sure you can adjust the gain for your ears. “Gain is the volume in specific regions of hearing — like high-pitched vs. low-pitched sounds — where you need it. If you’ve had a professional hearing test called an audiogram, you may also be able to type in the results,” Franck says.

Several microphones. You need standard microphones, which pick up all sounds, and also directional microphones, which focus on sounds in front of you (great for when you’re having a conversation).

Noise cancellation. Look for technology that filters out unwanted sounds, like the wind, loud background noise, or some of your own voice. “You want PSAPs that make your voice sound less ‘boomy’ to you when speaking. If you ever wear earplugs, you know how loud that voice can sound,” Franck says.

Comfort. Professionally dispensed hearing aids can be molded to your ear to fit perfectly. You won’t get that kind of fit with PSAPs, but you can find models with memory foam or several sizes of silicone tips. And if the PSAPs are uncomfortable, send them back.

More advice

You can find PSAPs online or sold by health care professionals and organizations. “Consider getting PSAPs from a local audiologist or hospital group that’s already researched the options and can teach you how to use the devices,” Franck suggests. “Until we have standard quality measures, it’s the safest way to go.”

NOTE:  AFL thanks Harvard Health for this informative article.