What You Need to Know About OTC Hearing Aids

By: Doug Garfield | Posted on: 09-15-2022 | Category: Hearing aids | OTC hearing aids

Of the 48 million Americans with hearing loss, only 20% use hearing aids. Why? Hearing loss is difficult to detect.

"The majority of people with untreated hearing loss are people who don't actually recognize they have a problem and therefore are not seeking help," explained Catherine Palmer, Ph.D., president of the American Academy of Audiology and Director of Audiology and Hearing Aids at the University of Pittsburgh Medical Center. "The rest of the untreated group realize they have hearing loss but don't pursue hearing aids for various reasons, including stigma and cost."

By 2060, that 48 million grows to 73 million. Given our penchant for ignoring hearing loss, the future promises considerable risk of social isolation, depression, mobility difficulty, falls, cognitive decline, and dementia for many people.

► This short video outlines the pros and cons of OTC hearing aids

Hearing loss time bomb

Knowing this healthcare time bomb ticks away, the FDA acted in 2017 to create a new regulatory class of over-the-counter hearing aids to increase the affordability and accessibility of hearing aids. The final ruling goes into effect on October 17, 2022.

"We're really excited about the market," said Barbara Kelley, executive director of the Hearing Loss Association of America. But, she added, "we think it's going to be confusing for consumers."

Let's look at OTC HAs and how they compare to prescription hearing aids.

What OTC HAs offer, the basics

OTC HAs won’t require a prescription or fitting by an audiologist. They will also be less expensive than professional-fitted hearing aids because of lower-level technology and no professional services.

OTC HAs

Amplify sound
Don't require a hearing test
Are approved for adults older than 18 with mild to moderate hearing loss.
Purchasers configure them, including the physical fit and tuning of the sound without professional support.

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Two types of hearing aids. What's the difference?

Soon there will be two classes of hearing aids—OTC HAs and prescription. Let's take a closer look at the key differences.

The FDA's regulatory standard for OTC HAs is the same standard that applies to Personal Sound Amplification Products (PSAPs), namely, ANSI/CTA 2051. OTC HAs are Personal Sound Amplification Products (PSAPs) that must comply with this standard (not all PSAPs do).

All OTC HAs must allow the user to adjust for frequency (bass-treble balance) and volume.
Some OTC HAs may be self-fitting, meaning the user will respond to a process that will adjust the listening program. This self-fitting feature is not required by the new regulation, however.
OTC HAs increase the volume of all sounds (frequencies); they don't isolate or mute specific frequencies.

OTC HAs may be helpful in quiet environments for a person with mild hearing loss. They aren't well suited to noisy places like restaurants, however, because they don't filter out distracting background noise. They amplify all sounds.

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The technology difference

What distinguishes the two types of hearing aids is technology. Prescription HAs are programmable. Audiologists can fine-tune them to amplify the particular sounds and frequencies you struggle to hear. The advanced technology also keeps background noise where it belongs, in the background. For example, prescription HAs will amplify a speaker's voice over excessive background noise in a public place so you can hear the speaker clearly.

OTC HAs will amplify the speaker's voice, but they will also amplify all the other noise in the room.

Pros and cons of OTC HAs and prescription HAs

Pros of OTC HAs

No prescription is required
Less expensive
Make distant sounds audible
Some models will connect to smart devices to stream music, television, and phone calls
First step toward hearing aids for mild hearing loss

Cons of OTC HAs

Require users to fit the device to their ears
Don't make nearby sounds clearer
Can't distinguish between sound frequencies or pitch
Limited adjustability, volume, and base-treble balance
Make all sounds louder
Can damage the ears and further reduce hearing
Not serviceable by all audiologists

8 questions you need to ask

Before buying OTC hearing aids, The Hearing Loss Association of America recommends you have answers to the following questions:

Is there a free trial period, or money back return policy? It’s up to you to check this because a trial or return policy is not an FDA requirement of OTC HAs.
Do the OTC HAs need a smartphone, app, or computer to install, operate, and customize to my needs?
Are they compatible with cellphones, or smartphones?
Do they have connectivity via Bluetooth, or telecoil to a smartphone, computer, or listening system?
Can the volume be adjusted? How do you control feedback?
Are they water/sweat resistant?
How do they control, reduce, or block out background, or wind noise?
How long is the battery life? Can it be recharged?

Pros and cons of prescription HAs

Pros of prescription HAs

Produce natural sound
Offer settings for a variety of hearing environments, such as wind noise reduction
Programmable hearing correction based on test results
Effective when there is a lot of background noise (e.g., restaurants)
Wide range of adjustments by the wearer
Some models have features to relieve tinnitus
Connect to smart devices to stream music, television, and phone calls
Trial period

Cons of prescription HAs

More expensive
Rarely covered by health insurance
Models using non-rechargeable batteries are more difficult to manage with limited hand dexterity

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OTC HAs...as simple as buying readers?

Anyone who thinks getting OTC HAs will be as easy as picking up a pair of inexpensive reading glasses to sharpen their vision should think again.

"That's a good analogy, except I'd like to clarify that when we put on glasses, typically, they correct our vision. When you put on a hearing aid, it doesn't always correct your hearing." —Barbara Kelly, Executive Director, Hearing Loss Association reporting on NPR

Why? Hearing loss is very individualized. People have difficulty with specific frequencies and locations.

"Hearing loss is unique to each person, and most do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax," Hearing Industries Association President Kate Carr said in a statement to NPR.

Before you buy

Your journey with hearing loss should start a hearing screening. Although not required for OTC HAs, we recommend you get your hearing screened by an audiologist to determine if you're a good candidate for them.

A hearing screening will confirm if you have hearing loss, and if you do, you'll learn how much hearing you've lost, the type, and if OTC HAs are appropriate for your hearing.

Avoid this mistake

Don't make the mistake of assuming you have hearing loss. For example, what you perceive as hearing loss, could be something entirely different. For example, perhaps you have impacted ear wax or an auditory processing disorder. Or your hearing loss could be a symptom of an underlying health problem (e.g., cardiovascular disease, a tumor, chronic kidney disease, or diabetes).

Find out the status of your hearing before you purchase OTC HAs. They may be inappropriate for your condition—and as mentioned, you may not be able to return them for a refund.

The FDA will release the final regulation on October 17, 2022. We'll keep you posted.

Need help with your hearing?

A great way to start is with a free, 15-minute hearing screening performed by an audiologist. It’s easy to find out if you have hearing loss. So don’t guess. Find out.

If you have hearing loss, your audiologist will explain