Who Can Buy OTC Hearing Aids?
The FDA's 2022 rule opened the door for millions of Americans to buy hearing aids without a prescription — but OTC aids aren't right for everyone. Here's how to know if you qualify.
The FDA's OTC Eligibility Standard
Under the FDA's 2022 ruling, OTC hearing aids are intended for adults 18 and older who perceive they have mild to moderate hearing loss. The key word is "perceive" — you don't need a formal hearing test or audiologist diagnosis to purchase an OTC device. You self-assess based on your own experience of hearing difficulty.
This is a significant departure from prescription hearing aids, which require a professional evaluation. The FDA designed OTC aids to be accessible, affordable, and self-managed — but that also means the responsibility for determining eligibility falls largely on you.
You likely qualify if you…
- Adults aged 18 or older
- Perceived mild to moderate hearing loss
- Difficulty hearing in noisy environments
- Trouble following conversations on the phone
- Frequently asking others to repeat themselves
- Turning up the TV louder than others prefer
OTC may not be right if you have…
- Children under 18 (require audiologist evaluation)
- Severe or profound hearing loss
- Sudden hearing loss (see a doctor immediately)
- Hearing loss in only one ear
- Ear pain, drainage, or visible ear canal blockage
- Dizziness or balance problems related to hearing
Understanding "Mild to Moderate" Hearing Loss
Hearing loss is measured in decibels (dB) on an audiogram. The general clinical ranges are:
| Category | Hearing threshold | OTC eligible? |
|---|---|---|
| Normal | 0–25 dB | Likely no need |
| Mild | 26–40 dB | Yes |
| Moderate | 41–55 dB | Yes |
| Moderately severe | 56–70 dB | Borderline — see audiologist |
| Severe | 71–90 dB | No — prescription required |
| Profound | 91+ dB | No — prescription required |
Why Age 18 Is the Cutoff
Children's hearing systems are still developing, and hearing loss in children can significantly affect speech, language, and learning. The FDA requires children to be evaluated by a licensed audiologist or physician to ensure they receive the right level of care and amplification. OTC devices are not designed or tested for pediatric use.
When to see a doctor first
Sudden hearing loss, hearing loss in only one ear, ear pain, drainage, or dizziness are medical symptoms that require evaluation before using any hearing aid. These can indicate conditions that need treatment, not amplification.
Do You Need a Hearing Test First?
Legally, no. The FDA's OTC category was specifically designed to remove the requirement for a prior exam. However, getting a baseline hearing test is still a smart idea for several reasons:
- It confirms your loss is actually mild to moderate — not severe
- It gives you an audiogram you can use to fine-tune OTC device settings
- It rules out medical causes of hearing loss that need treatment
- It establishes a baseline to track changes over time
Many audiologists offer hearing screenings at low or no cost. Online hearing tests can also give you a rough sense of your hearing profile before you buy.
The Bottom Line
If you're an adult 18 or older who's been noticing difficulty hearing in everyday situations — conversations, TV, phone calls — and you don't have any of the red-flag symptoms listed above, you're likely a good candidate for OTC hearing aids. They're a legitimate, FDA-regulated option that can meaningfully improve quality of life at a fraction of the cost of prescription devices.
If you're unsure, a quick hearing screening with an audiologist can give you the confidence to make the right call.