Over-the-Counter (OTC) Hearing Aids

Over-the-Counter (OTC) Hearing Aids

As of October 17, 2022, you can now purchase hearing aids without a prescription thanks to a final rule established by the U.S. Food and Drug Administration (FDA). As a result, millions of Americans will now have access to these devices through local retailers or online – no medical exam or fitting by an audiologist needed.

This article was written by
Resources
Education & Awareness

Over-the-Counter (OTC) Hearing Aids

Over-the-Counter (OTC) Hearing Aids

Over-the-Counter (OTC) Hearing Aids

Funding for content provided by Bayer®
Content medically reviewed by
Author & Expert Contributors
written by
Author & Expert Contributors
written by
Content medically reviewed by

As of October 17, 2022, you can now purchase hearing aids without a prescription thanks to a final rule established by the U.S. Food and Drug Administration (FDA). As a result, millions of Americans will now have access to these devices through local retailers or online – no medical exam or fitting by an audiologist needed.

Who should consider OTC hearing aids?

It is strongly recommended by industry experts that you get a hearing test – especially before making a purchase. If your insurance does not cover hearing tests, or if you cannot afford or choose not to visit a hearing professional, other options include testing via smartphone apps or online hearing tests. However, it’s important to note that your ability to hear sounds depends on the environment along with the sound quality of your phone or device being used.

The new rule applies to adults (18+) with recognizable signs of mild to moderate hearing loss, which includes but is not limited to the following situations:

  • Trouble hearing conversations in a noisy restaurant
  • Frequently asking others to repeat what was said, and/or
  • Turning up the TV/music to levels that are uncomfortable to others

Children under 18 or anyone suffering from severe* or more complex hearing loss should not use an OTC hearing aid.

*The Center for Disease Control (CDC) defines severe hearing loss as hearing no speech when a person is talking at a normal level and only some loud sounds.

How do I know if I have mild to moderate hearing loss?

It is strongly recommended by industry experts that you get a hearing test – especially before making a purchase. If your insurance does not cover hearing tests, or if you cannot afford or choose not to visit a hearing professional, other options include testing via smartphone apps or online hearing tests. However, it’s important to note that your ability to hear sounds depends on the environment along with the sound quality of your phone or device being used.

Unsure about your hearing levels? Find out your Hearing Number - a new sound metric launched by the Johns Hopkins Bloomberg School of Public Health. This metric will help you better understand your hearing and if you could benefit from hearing technologies, like a hearing aid.

Important Update: Acetaminophen

There’s been a lot of talk recently about misleading claims that taking acetaminophen during pregnancy can cause autism. We’ve pulled together some FAQs and answers to help families.
Learn more and get the facts about acetaminophen

Where can I buy OTC hearing aid devices?

These devices will be available both in stores – pharmacies, big box chains, electronic stores – and online directly from manufacturers in addition to major retail hubs. While some retailers have publicly announced they will be selling hearing aids at stores nationwide, other retailers are currently only selling in specific locations. Online options might be beneficial for those with limited access to a brick-and-mortar retailer, including rural communities or areas where local retailers are not yet selling OTC hearing aids.

Online Buying Tip: Advertising can sometimes be misleading. If you’re skeptical about buying from an online store and have limited access to purchasing an item in-person, take a moment to do a bit of research first and contact your nearest retailer or healthcare provider to help answer your questions.

A NOTE ABOUT DYE-FREE PRODUCTS: Dye-free medications and supplements are a great option for individuals who prefer or require products without dyes, such as those with allergies, sensitivities, or personal preferences. Importantly, both dye-containing and dye-free options are held to the same rigorous safety and quality standards. If you’re unsure which is right for you or your family, talk to your pharmacist or healthcare provider. They can help you choose the option that best suits your needs.

How much do they cost?

OTC hearing aids provide consumers with more affordable options. Manufactures of these devices are estimating that their models may sell between $200 and $1,000 per pair, depending on the type of device, style, and features included. By comparison, purchasing prescription hearing aids through an audiologist can frequently cost at least $5,000 a pair. The FDA estimates that increased access to OTC hearing aids will save consumers approximately $63 million per year. Now that’s music to our ears!

Return Policy: Before you buy an OTC hearing aid, ask about the retailer’s return policy and hearing aid manufacturer’s warranty. The recommendation is to choose a device with a generous return policy (at least 30 days) as it might take several weeks to know whether new hearing aids might work for your unique situation.

Safe Use Tips & Takeaways

Heart Health Takeaways

Always read and follow the label carefully. Look for the words “over-the-counter (OTC) hearing aid” listed on the package.

  • Research different brands to learn more about them and select the right option for your specific needs.
  • Be sure to check for smartphone requirements as certain devices may require you to download and use an app on your smartphone - and some of those may only work with iPhones and not Androids. Please read the maker's website closely or review the material inside the package provided.

Frequently Asked Questions (FAQ)

What is fluoride?
Fluoride is a natural mineral found in water, soil, and some foods. It strengthens your enamel, repairs early signs of damage, and makes teeth more resistant to acids from bacteria and sugar.
Is fluoride toothpaste still the most effective option, or are fluoride-free formulas just as good?
Fluoride is still the gold standard for cavity protection. Fluoride-free options can clean your teeth, but they don’t offer the same enamel-strengthening power.
Is fluoride safe for daily use?
Yes. When used as directed, fluoride is safe and effective. It’s been trusted and recommended by major health organizations for over 70 years.
How does fluoride actually protect teeth?
It strengthens enamel, repairs early signs of decay, and makes teeth more resistant to acids from bacteria and sugary foods.
Are there any risks to using fluoride long-term?
The main risk—especially for young kids—is swallowing too much, which can lead to mild fluorosis. Using the right amount prevents this. For parents, supervise brushing to ensure kids spit out the toothpaste and don't swallow it. 
At what age should kids start using fluoride toothpaste?
As soon as the first tooth appears!

* Under 3 years: a tiny rice-sized smear
* Ages 3–6: a pea-size amount  

Supervise brushing so they don’t swallow it.
Is fluoride still safe and recommended for kids with all the claims online?
Yes. A lot of online claims can be confusing, but decades of research show fluoride is safe and strongly recommended for cavity prevention when used properly.
How much fluoride should my child get from toothpaste?
Use age-appropriate amounts and brush twice a day. If your water isn’t fluoridated, ask your dentist about additional options.
How do I know which kids’ toothpaste claims are real and not just marketing?
Check for the ADA Seal of Acceptance and choose brands your dentist recommends.
Do fluoride-free or “natural” toothpastes protect kids from cavities?
They can help clean teeth, but they don’t provide the same cavity protection as fluoride toothpastes.
Are fluoride-free toothpastes just as effective for adults?
Not for cavity prevention. Fluoride-free toothpastes can help with cleaning and freshening breath, but they do not protect against cavities the way fluoride does. For adults, or anyone who is prone to cavities, fluoride toothpaste remains the most effective option for preventing tooth decay.
Do fluoride alternatives like nano-hydroxyapatite (nHAp) make a difference?
Yes—nHAp can help with sensitivity and early enamel repair. But it hasn’t matched fluoride’s cavity-prevention strength in studies.
How do I compare fluoride vs. fluoride-free options if I have sensitivity or enamel wear?
Fluoride is best for strengthening enamel. nHAp may help with sensitivity. Some people benefit from using both in a balanced routine.
Are whitening toothpastes safe to use with fluoride or fluoride-free products?
Most are safe but can be abrasive. Choose gentle formulas and avoid using them every single day—especially for kids.
What should I look for when choosing an OTC toothpaste?
Pick products with proven active ingredients (like fluoride), check for the ADA Seal, and avoid unnecessary additives or sweeteners.
Does fluoride affect hormones or the brain?
No credible scientific evidence shows fluoride at levels used in toothpaste or fluoridated water disrupts hormones or causes neurodevelopmental harm.
What should I do if my community stops adding fluoride to the water?
Use fluoridated toothpaste, consider fluoride rinses, and talk to a dentist about fluoride supplements for kids.
Do fluoride supplements have side effects?
They’re safe when used under dental guidance and typically recommended for children in areas without fluoridated water.
What’s the best way to make sure I’m getting enough fluoride?
Brush twice daily with fluoride toothpaste, drink fluoridated tap water if available, and ask your dentist for personalized advice if you’re cavity-prone.

Medium length headine

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique.

Text Link
Consumer Medical Devices
No items found.
Adults
65+