Guide: hearing
Over-the-counter hearing aids, explained
What changed in 2022, who the FDA rule covers, and the signs that mean seeing a professional first.
- Oct 17, 2022
- The day the OTC category took effect
- 4 signs
- On every box that mean seeing a professional first
FDA, read Oct 2, 2026. See source
On this page
The rule
The FDA established over-the-counter hearing aids as a category for adults 18 and older with perceived mild to moderate hearing loss, effective October 17, 2022. They are sold in stores and online with no exam or prescription1.
Perceived means the buyer's own sense of their hearing. People with more severe loss, or who do not hear loud sounds well, may need a professionally fitted aid; the FDA says an OTC aid may not suit them1.
See a professional before buying OTC if
The FDA requires OTC hearing aid packaging to carry these warnings1.
The ear has a birth defect or an unusual shape (helpful, not required)
Blood, pus or fluid came out of the ear in the past 6 months (helpful, not required)
Hearing changed suddenly in the past 6 months (helpful, not required)
One ear hears worse than the other (helpful, not required)
Any one of these is a reason to see a hearing professional or doctor first. This list is not medical advice.
OTC and professionally fitted, side by side
| Question | OTC hearing aids | Professionally fitted (hear.com example) |
|---|---|---|
| Who for1 | Adults 18+, perceived mild to moderate loss (FDA) | Fitted by a hearing care professional (hear.com) |
| Exam or prescription1 | Not required (FDA) | Professional fitting included (hear.com) |
| Published price2 | Varies by maker; not compared here | $1,599 to $5,150 by model (hear.com list) |
| Trial2 | Set by each seller | 45-day no-risk trial (hear.com) |
Read October 2, 2026.
About this page
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Costs are published medians or list prices on the date we read them. The provider's or community's own page, contract and written quote are the final word on price and terms.
