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Over-the-Counter (OTC) Hearing Aids—What to Know

Nov 07, 2022

By Cara Everett, MS, RDN
Medically Reviewed by Lindsey Jorgensen, AuD, PhD
Reviewed by Kathleen Cameron, BSPharm, MPH, Senior Director for NCOA’s Center for Healthy Aging
Fact Checked

OTC Hearing Aids: Key Takeaways

  • More affordable hearing aid options are now a reality, thanks to a new category of over-the-counter (OTC) hearing aids established by the U.S. Food and Drug Administration (FDA) in August 2022.
  • OTC hearing aids are designed to treat mild to moderate hearing loss in adults 18 years and older. 
  • The average price of OTC hearing aids will now be several thousand dollars cheaper than that of prescription hearing aids.
  • On October 17, 2022, the FDA’s OTC hearing aids ruling went into effect, which lets you buy a hearing aid without a medical exam, prescription, or professional fitting.

Nearly 25% of Americans between the ages of 65 and 74 have hearing loss severe enough to affect their daily life, and that number jumps to 50% for people over the age of 75.1 Even though hearing loss can be a significant burden, many people wait an average of 10 years before buying hearing aids.2 Reasons for waiting vary, but common beliefs include the perception that hearing aids are too expensive or that they aren’t helpful in treating hearing loss.

The FDA’s final rule on OTC hearing aids is intended to tackle both of these barriers.3 By increasing innovation and competition among OTC hearing aid companies, the FDA rule is designed to create more options for shoppers who want affordable hearing aids. Read on for more information about what OTC hearing aids are, the best-rated OTC hearing aids, and ways to save money when buying them.

Why you can trust our expert review

5,300
Hours of Research
12
Experts Consulted
18
Brands Considered
95
Models Considered
12
Models Selected

Our Reviews Team recommends products and services we believe provide value in the lives of our readers. We’ve spent more than 5,000 hours conducting in-depth research on hearing aid devices to give you the most accurate hearing aid reviews. To make these selections, we:

  • Consulted with audiologists and geriatric care experts
  • Mystery shopped 18 brands
  • Selected 12 models as best hearing aids
  • Surveyed hundreds of hearing aid users
  • Tested various models of hearing aids
  • Interviewed experts in the field
  • Read thousands of verified customer reviews

Read more about our hearing aid review methodology.

What are over-the-counter (OTC) hearing aids?

OTC hearing aids are defined by the FDA as medical devices designed to treat mild to moderate hearing loss in adults 18 years and older.4 They are classified separately from prescription hearing aids, with each having its own set of regulations for safety and efficacy. 

Hadassah Kupfer, a doctor of audiology and adjunct instructor for City University of New York’s doctor of audiology program in Brooklyn, New York, shared some of the benefits of the FDA making hearing aids available to more Americans: Not everyone is able to go for multiple visits to an audiologist (due to location, mobility, and cost reasons) in order to get the perfect hearing aid fitting. And when the alternative is having no hearing care at all, it is helpful to have a category that provides some benefit, even if it may be limited from a professional perspective,” said Kupfer.

OTC vs. prescription hearing aids

Both OTC and prescription hearing aids are regulated as medical devices by the FDA, but OTC hearing aids are less expensive and easier to buy than prescription hearing aids for a number of reasons. See the table below for some of the main differences between the two types.

Table 1 OTC hearing aids vs. prescription hearing aids, as of October 2022

OTC hearing aids

Prescription hearing aids

Regulated by FDA

Yes

Yes

Levels of hearing loss covered

Mild to moderate

Mild, moderate, severe,
and profound

Average price

$1,600*

$4,600

Hearing exam required?

No

Yes

Prescription required?

No

Yes

Fitting appointment required?

No

Yes

Purchasing options

In retail stores, online,
and in some hearing care clinics

Hearing care clinics

*Based on President Biden’s estimate that customers may save up to $3,000 compared to the average price of prescription hearing aids.5

While OTC hearing aids are more readily available than prescription devices, they’re not the best choice for everyone. Kupfer cautioned potential hearing aid users that they may be giving up a certain level of personalized care by choosing OTC hearing aids.

“A successful hearing aid fitting is so much more than the equipment. Just like glasses are not a one-size-fits-all solution, hearing aids also operate using a prescription in which they are tuned pitch by pitch based on your hearing test results,” Kupfer said. “Even if the OTC devices can be adjusted generally for bass and treble, a person will be missing out on the unique prescription that would help them hear at their max potential.

“In addition, [with OTC hearing aids] there is no opportunity for professional sizing, custom earpieces, counseling on proper use and maintenance, or follow-up fine tuning. So a person may be discouraged when they do not have the successful outcome they were hoping for, and come to the (incorrect) conclusion hearing aids don’t work for them,” Kupfer said.

OTC hearing aids vs. PSAPs

Although OTC hearing aids are not approved by the FDA for more significant hearing loss, they are true hearing aids that use the same technology as prescription hearing aids, according to the National Institute on Deafness and Other Communication Disorders (NIDCD).6 

On the other hand, personal sound amplification products (PSAPs), also known as hearing amplifiers or sound amplifiers, are not meant to be used as a treatment for hearing loss, nor are they regulated by the FDA.7 

Hearing aids amplify only certain sounds based on your hearing profile, but PSAPs amplify all sounds equally. People with normal hearing often use PSAPs for recreational purposes, such as birdwatching, to make all sounds in the environment louder.

The FDA also points out the following distinction between hearing aids and PSAPs: Because such PSAPs are regulated as consumer electronics and not medical devices, they may be more variable in terms of product quality compared to hearing aids.”7 

While PSAP devices are useful under some circumstances, if you have hearing loss you’ll be better supported with a quality pair of hearing aids.

OTC hearing aids pros and cons

OTC hearing aids can be an excellent solution for many people’s hearing loss, but they do have drawbacks compared to prescription hearing aids. Let’s take a look at the pros and cons, so you can make an informed decision about what type of hearing aids are right for you.

Pros Lower average cost compared to prescription hearing aids Some brands (such as Lively) offer remote evaluations and adjustments by an audiologist Many come with a smartphone app that allows you to adjust the volume and settings
Cons Not designed to treat hearing loss that is more significant or associated with an injury or underlying medical condition Self-fitting, which means they cannot be custom fit for your ear Typically offer fewer features than prescription hearing aids No in-person hearing care provided after the purchase Most OTC hearing aids come with shorter warranties than prescription hearing aids

Who are OTC hearing aids for?

OTC hearing aids are designed for adults 18 years and older who have mild to moderate hearing loss. Candice Ortiz-Hawkins, doctor of audiology at Capital Institute of Hearing and Balance in Silver Spring, Maryland, offered guidance for people wondering if their hearing loss fits into that range. “If a person requires speech to be loud, even in quiet environments, or has great difficulty participating in conversations or hearing in noisy environments, their hearing loss is likely more severe than the permissible range for OTC hearing aids to work,” said Ortiz-Hawkins.

Ortiz-Hawkins noted certain instances in which you should seek the help of a doctor, audiologist, or other hearing care professional for an in-person evaluation. The FDA recommends a hearing exam by a licensed medical professional for people with the following symptoms:8

  • Injury to or deformity of the ear
  • Fluid, pus, or blood coming from one or both ears 
  • Sudden or fluctuating hearing loss
  • Better hearing in one ear than the other
  • Ringing or buzzing in one or both ears
  • Constant pain in one or both ears
  • Vertigo or dizziness
  • A full or plugged feeling in the ear 

An in-person evaluation is the only way to diagnose and treat an underlying medical condition.

Where to buy OTC hearing aids

Direct-to-consumer (DTC) hearing aids are already available online from some manufacturers, such as Eargo, Jabra Enhance, and Lexie. DTC means the hearing aids are sold directly to the consumer (rather than through a hearing clinic). DTC hearing aids filled the gap between the FDA’s first announcement that it would create a category of OTC hearing aids in 2016, and when the rule was finalized in August 2022.9

Effective October 17, 2022, you can now buy OTC hearing aids both online and in stores where health care devices are sold, such as Best Buy, Walgreens, and CVS.

How much will OTC hearing aids cost?

The average price for a pair of prescription hearing aids is $4,600, but OTC hearing aids will hopefully cost much less.10 The federal government estimates Americans could save up to $3,000 on hearing aids by choosing OTC brands rather than prescription devices.11 If that’s the case, the average cost for a pair of OTC hearing aids would be around $1,600.

Some OTC hearing aids may even be priced well below that amount. Barbara Kelley, the executive director of the Hearing Loss Association of America, believes OTC hearing aids may cost $300–$500 per ear.12 

With the FDA opening up the OTC hearing aid market to more manufacturers, the cost of hearing aids may come down even further. Lower prices for hearing aids could encourage millions of people to get the help they need for hearing loss. The NIDCD states about 37.5 million Americans are affected by disabling hearing loss, but only 16% (or 6 million) use hearing aids.13 

Our survey of 600 hearing aid users found cost was at the forefront of respondents’ buying decisions. Price ranked as the second-most important factor when customers were deciding which hearing aid to buy, right behind ease of use. 

Top OTC hearing aids to consider

Audien is one brand that currently sells devices starting at $99. While Audien hearing aids don’t have as many features as some of the higher-priced OTC brands, they can still improve hearing for people with mild to moderate hearing loss.

Companies such as Audicus and Jabra Enhance make higher-tech hearing aids that include Bluetooth streaming, rechargeable batteries, and feedback suppression to cut down on background noise so you can hear conversations more clearly. The most advanced model from Audicus, the Omni, costs $3,398. That’s quite a bit more expensive than Audien hearing aids, but still cheaper than the average price for a pair of prescription hearing aids.

For more information on low-priced hearing aids, see our review of the most affordable hearing aids on the market.

How to save money on hearing aids

Hearing aids are a major expense. According to Johns Hopkins Medicine, hearing aids can be the third-largest purchase a person makes in their lifetime, after a house and car.14 While OTC hearing aids are getting less expensive, ranging in price from $99–$3,400 per pair, they are still a big investment. 

Read on for ways you can save money when shopping for and buying OTC hearing aids.

Look for sales

Hearing aid manufacturers run sales on their devices quite often. For instance, our Reviews Team found that of the brands listed in our article, The 6 Best Affordable Hearing Aids of 2022, four companies were selling devices at reduced prices over the Labor Day weekend. 

Search for discounts and financial assistance

Although in most cases Medicare doesn’t cover the cost of hearing aids, you may be eligible for reduced-price or free hearing aids through other organizations. For example, any veteran who is eligible for general Veterans Administration health care can also receive free hearing exams, hearing aids, and batteries for their hearing aids. Details of this benefit are explained on the Veterans Affairs website.

It’s worth checking to see if you qualify for financial assistance before buying hearing aids. Some insurance companies, for instance, give an allowance toward the purchase of hearing aids. If you are a Medicaid recipient, your state’s Medicaid program may cover some or all of the costs associated with hearing exams and devices.15

Learn about other organizations offering financial assistance for hearing aid purchases on these websites:

Check out NCOA’s Benefits CheckUp tool to see which benefits you’re eligible for.

Take advantage of payment plans

Most OTC and prescription hearing aid companies offer financing plans for people who would prefer paying a smaller amount each month rather than paying the full cost up-front. 

Audicus also offers a unique plan called Audicus Plus. For $99 per month, you get a pair of hearing aids that are upgraded every 18 months, insurance coverage for loss or damage, and online support from Audicus hearing specialists. 

As more hearing aid manufacturers enter the OTC hearing aid market, the hope is more of them will be offering plans like these to make the cost of their hearing aids more competitive.

OTC hearing aids: Bottom Line

OTC hearing aids are limited in the level of personalized care provided, compared to prescription hearing aids, and they can’t treat all levels of hearing loss or hearing-related medical conditions since they are only approved for mild to moderate hearing loss. 

But the lower prices and easier buying process offered by OTC hearing aid manufacturers is a big step forward in allowing more Americans the opportunity to get the help they need.

Frequently Asked Questions

Have questions about this review? Email us at reviewsteam@ncoa.org.

Sources

  1. National Institutes on Deafness and Other Communication Disorders. Quick Statistics About Hearing. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
  2. Johns Hopkins Medicine. The Hidden Risks of Hearing Loss. Found on the internet at https://www.hopkinsmedicine.org/health/wellness-and-prevention/the-hidden-risks-of-hearing-loss
  3. U.S. Food and Drug Administration. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. Found on the internet at https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans.
  4. Federal Register. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Found on the internet at https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
  5. The White House. Statement by President Joe Biden on FDA Hearing Aids Final Rule. Found on the internet at https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/16/statement-by-president-joe-biden-on-fda-hearing-aids-final-rule/
  6. National Institute on Deafness and Other Communication Disorders. Over-the-Counter Hearing Aids. Found on the internet at https://www.nidcd.nih.gov/health/over-counter-hearing-aids
  7. U.S. Food and Drug Administration. Hearing Aids and Personal Sound Amplification Products: What to Know. Found on the internet at https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know
  8. U.S. Food and Drug Administration. Benefits and Safety Issues. Found on the internet at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=801.420
  9. U.S. Food and Drug Administration. FDA takes steps to improve hearing aid accountability. Found on the internet at https://www.fda.gov/news-events/press-announcements/fda-takes-steps-improve-hearing-aid-accessibility
  10. White House. FDA Takes Action to Deliver Lower-Cost, Innovative Hearing Aids to Millions More Americans. Found on the internet at https://obamawhitehouse.archives.gov/blog/2016/12/07/fda-takes-action-deliver-lower-cost-innovative-hearing-aids-millions-more-americans
  11. The White House. Statement by President Joe Biden on FDA Hearing Aids Final Rule. Found on the internet at https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/16/statement-by-president-joe-biden-on-fda-hearing-aids-final-rule/
  12. Washington Post. What to know before buying over-the-counter hearing aids. Found on the internet at https://www.washingtonpost.com/health/2022/08/17/over-the-counter-hearing-aids/
  13. National Institutes on Deafness and Other Communication Disorders. Quick Statistics About Hearing. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
  14. Johns Hopkins University. Hearing Aid Coverage Could Be ‘Transformational.’ Found on the internet at https://hub.jhu.edu/2021/11/15/medicare-hearing-aid-coverage-nicholas-reed/
  15. Hearing Loss Association of America. Medicaid. Found on the internet at https://www.hearingloss.org/hearing-help/financial-assistance/medicaid/

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