OTC hearing aids
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- Lexie Lumen self-fitting OTC hearing aids. Best for: Setting up with a phone app. See options on Amazon
- Jabra Enhance Select self-fit hearing aids. Best for: Adults wanting a self-fit OTC option. See options on Amazon
- Hearing aid cleaning kit. Best for: Keeping tips free of wax. See options on Amazon
Who OTC hearing aids are for
The FDA says OTC hearing aids are intended for use by people 18 years of age and older to help with perceived mild to moderate hearing loss. If you are younger than 18, you need to buy hearing aids by prescription; federal rules prohibit the sale of an OTC hearing aid to or for a person younger than 18.
They are not for the treatment of severe or profound hearing loss. Because OTC hearing aids are limited in their maximum output, the FDA notes they may not be enough for more severe losses. The FDA says close to 30 million adults living in the U.S. have some degree of hearing loss.
Red flags: see a doctor first
The FDA lists conditions that call for a doctor, preferably an ear-nose-throat specialist, before using an OTC hearing aid:
- Your ear has a birth defect or an unusual shape, or was injured or deformed in an accident.
- You saw blood, pus or fluid coming out of your ear in the past 6 months.
- Your ear feels painful or uncomfortable.
- You have a lot of ear wax, or think something could be in your ear.
- You get really dizzy or have vertigo.
- Your hearing changed suddenly in the past 6 months, or gets worse and then better again.
- You have worse hearing in one ear, or ringing or buzzing in only one ear.
For wax buildup, see our ear wax removal kit guide, but ask a doctor if you are unsure what is in your ear.
What FDA rules require
| Rule | What it says | Why it matters |
|---|---|---|
| Output limit | Not over 111 dB SPL; 117 dB SPL with input-controlled compression activated | Caps how loud the device can get |
| Insertion depth | Designed to stay at least 10 mm from the eardrum | Limits how deep the tip can go |
| Volume and tuning | User-adjustable volume control, plus tools, tests or software to customize | You set it up yourself |
| Package labeling | Marks "OTC" and "hearing aid", battery details, and the return policy | Lets you compare before buying |
Details are from 21 CFR 800.30, the FDA rule for OTC hearing aids.
Before you buy
- Return policy. The outside package must state the manufacturer's return policy, or say that none exists.
- Warranty. The FDA says its OTC hearing aid regulations do not require manufacturers to provide a warranty, so check the return or warranty period and leave time to test the device in different settings.
- Phone or remote. The package must say whether you need a phone or remote to control it.
- Batteries. The package must list battery type and number and whether batteries are included.
- Used or rebuilt. If a hearing aid is used or rebuilt, the package must declare it.
OTC vs prescription
The FDA notes that OTC hearing aids can be bought in a store, through an online retailer, or from an audiologist or hearing aid dispenser. Federal rules require the labeling to advise that professional services are available, so you can still get a hearing test or help fitting an OTC device. If your hearing loss seems severe, an OTC device does not help, or you have a red flag symptom, a professional evaluation is the next step.
The user manual must also describe events that could damage the device, such as ear wax buildup, drops, immersion in water or excessive heat, and possible side effects such as skin irritation and faster buildup of ear wax.
Reporting problems
If you have a problem with an OTC hearing aid, the FDA says you can report it through MedWatch or by calling 1-800-FDA-1088. Stop using a device that causes pain, and see a doctor for drainage or sudden hearing changes.
For listening in noisy places without a hearing aid, see our bone conduction headphones guide, and for safe volume while exercising, our wireless sport earbuds guide.
What to look for when you buy
Lexie Lumen self-fitting OTC hearing aids
Best for: Setting up with a phone app
The FDA 510(k) record K223137 lists Lexie Lumen Self-Fitting OTC Hearing Aids with the Lexie application.
Watch out: Check the return period on the package before opening.
See options on AmazonJabra Enhance Select self-fit hearing aids
Best for: Adults wanting a self-fit OTC option
The FDA 510(k) record K254108 lists Jabra Enhance Select Self-fit.
Watch out: Not for severe or profound hearing loss.
See options on AmazonHearing aid cleaning kit
Best for: Keeping tips free of wax
FDA rules require OTC manuals to describe ear wax buildup as an event that can affect the device.
Watch out: Follow your device maker's cleaning steps.
See options on AmazonQuestions people ask
- Who can use OTC hearing aids?
- Adults 18 and older with perceived mild to moderate hearing loss, per the FDA.
- Do I need a hearing test first?
- No exam or prescription is required, but the FDA lists red flag symptoms that call for a doctor first.
- How loud can OTC hearing aids get?
- FDA rules cap output at 111 dB SPL, or 117 dB SPL with input-controlled compression.
- Do OTC hearing aids come with a warranty?
- Not necessarily; the FDA does not require one, but the package must state the return policy.
- Are OTC hearing aids good for severe hearing loss?
- No. The FDA says they are not for severe or profound hearing loss.
Sources
- OTC Hearing Aids: What You Should Know (fda.gov), U.S. Food and Drug Administration
- 21 CFR 800.30, Over-the-counter hearing aid controls (ecfr.gov), Electronic Code of Federal Regulations
- 510(k) K223137: Lexie Lumen Self-Fitting OTC Hearing Aids (accessdata.fda.gov), U.S. Food and Drug Administration
- 510(k) K254108: Jabra Enhance Select Self-fit (accessdata.fda.gov), U.S. Food and Drug Administration