Over-the-Counter Hearing Aids and What to Know Before You Buy (FDA Guide 2026)
Last updated: October 22, 2026.
Disclosure: As an Amazon Associate I earn from qualifying purchases. Some links below are affiliate links, which means this site may earn a small commission at no extra cost to you.
- OTC hearing aids are for adults 18 and older with perceived mild to moderate hearing loss (FDA).
- Check the package for “OTC” and “hearing aid” and read the warnings about when to see a doctor.
- Sound amplifiers (PSAPs) are not hearing aids and are not for people with hearing loss.
- Batteries, dryers and cleaning kits are listed below with Amazon links.
Since October 2022, adults in the United States with mild to moderate hearing loss can buy hearing aids without a prescription, in stores or online. That can save time, but it also makes it easy to buy the wrong thing. This guide explains what the FDA and the National Institute on Deafness and Other Communication Disorders (NIDCD) say about over-the-counter (OTC) hearing aids, what to check on the box, and which popular batteries and care items are sold on Amazon. We do not recommend a specific hearing aid here, because the right choice depends on your hearing.
1. What Is an OTC Hearing Aid?
The FDA says it established a new category of OTC hearing aids for adults 18 and older with perceived mild to moderate hearing loss, which took effect on October 17, 2022. A hearing aid is a medical device worn behind or within the ear canal, and the FDA regulates all hearing aids. NIDCD explains that OTC hearing aids can be bought directly, without visiting a hearing health professional, that you fit them yourself, and that you may be able to adjust them in ways prescription hearing aid users cannot.
2. Are They Right for You?
NIDCD says OTC hearing aids are not meant for children or for adults with more severe hearing loss or significant difficulty hearing, because they may not amplify sounds enough. You might have mild to moderate hearing loss if, for example:
- Speech or other sounds seem muffled.
- You have trouble hearing in a group, in a noisy area, on the phone, or when you cannot see who is talking.
- You ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
- You turn up the volume higher than other people prefer when listening to TV or music.
The FDA also says some people should see a doctor, preferably an ear-nose-throat (ENT) doctor, before buying, to look for causes of hearing loss that need medical treatment other than hearing aids. The box has a warning section listing “red flag” conditions. Read it before you buy, and see a doctor if any of them apply to you.
3. Hearing Aid vs. Sound Amplifier
NIDCD notes that personal sound amplification products (PSAPs) are a different category. They are meant for people without hearing loss, for example for bird-watching, and they are not regulated as medical devices by the FDA. If you have hearing loss, look for a product whose package says “OTC” and “hearing aid”. The FDA says OTC hearing aids must show required labeling information on the outside of the box, including warnings and signs that you should see a doctor. If you cannot find the outside package labeling, the FDA says to contact the seller or manufacturer.
4. A Quick Buying Checklist
- The package says “OTC” and “hearing aid” and you are 18 or older (FDA).
- You have read the outside labeling, including “When to see a doctor” (FDA).
- Check what the warranty covers, and the return policy (FDA suggests considering warranty parts and services).
- Choose features that match your daily listening, such as phone calls or noisy places (FDA).
- If it does not help enough, ask for help from a hearing healthcare professional (FDA).
- Report problems such as skin irritation or injury from the device to the FDA through MedWatch or 1-800-FDA-1088.
Browse OTC hearing aids on Amazon →
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5. Batteries and Care Items
If your hearing aid is not rechargeable, you will need the right battery size. Check your device manual: sizes 312, 13 and 675 are common, and color-coded tabs help match them. Moisture and earwax can damage devices, so a dryer or a cleaning kit helps. Always follow your manufacturer’s instructions.
| Product | What stands out |
|---|---|
| Duracell Hearing Aid Batteries, size 13 (60 pack) | Common size 13; 10 packs of 6 |
| Duracell Hearing Aid Batteries, size 675 (12 pack) | Size 675 for stronger devices |
| Duracell Hearing Aid Batteries, size 312 (32 pack) | Size 312 for small devices |
| PerfectDry LUX hearing aid dryer | Dryer with UV-C light box |
See Duracell Size 13 Batteries on Amazon →
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See Duracell Size 312 Batteries on Amazon →
As an Amazon Associate I earn from qualifying purchases.
6. Frequently Asked Questions
Do I need a hearing test before buying an OTC hearing aid?
The FDA says an examination or doctor’s appointment is not required for adults 18 and older with perceived mild to moderate hearing loss to buy OTC hearing aids. In some cases, though, you should see a doctor first. Read the package warnings.
What if my hearing loss is more serious?
NIDCD says OTC hearing aids are not meant for more severe hearing loss. A hearing health professional can help you find the right device.
Are personal sound amplifiers the same as hearing aids?
No. NIDCD says PSAPs are for people without hearing loss and are not regulated as medical devices by the FDA.
Can I still go to an audiologist?
Yes. The FDA says you can also get hearing aids from a hearing health care professional if you prefer.
Is this medical advice?
No. This is general information. Please talk with a doctor or audiologist about your own hearing.
Related Guides
- Phones for Hearing Loss, Amplified, Hearing Aid Compatible and Captioned (FCC Guide 2026)
- Reading Glasses, Magnifiers and Lighting for Seniors to See Small Print (2026 Guide)
- Medical Alert Systems for Seniors, What to Ask and How to Avoid Scams (2026 Guide)
Sources
- FDA: OTC Hearing Aids, What You Should Know
- FDA: How to Get Hearing Aids
- NIDCD: Over-the-Counter (OTC) Hearing Aids
As an Amazon Associate I earn from qualifying purchases. This guide is general information, not medical or professional advice. This site is not affiliated with any government agency or product maker.
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