OTC vs Prescription Hearing Aids: Price and Rules
The FDA's over-the-counter category, in effect since October 17, 2022, lets adults buy hearing aids without an exam, a prescription or a fitting. Under 21 CFR 800.30 an OTC aid is for a person aged 18 or older “to compensate for perceived mild to moderate hearing impairment.” Everything else, including children and severe or profound loss, stays with prescription devices.
The rules in numbers
| Rule | OTC hearing aid |
|---|---|
| Minimum age | 18 |
| Maximum output | 111 dB SPL (117 dB SPL with input-controlled compression) |
| Insertion depth | at least 10 mm from the eardrum |
| Return policy | must be stated on the outside of the box (or that there is none) |
| Warranty | not required by the rule |
The prices side by side
| Group | Models | Lowest | Median start | Highest |
|---|---|---|---|---|
| OTC and earbuds | 18 | $98 | $949.48 | $2,498 |
| Provider-fitted | 31 | $1,299.98 | $2,798 | $4,898 |
The median fitted starting price is $1,848.52 above the median OTC starting price. The groups overlap: the dearest OTC pairs, such as Audicus and Jabra Enhance's direct models, cost more than Costco's fitted packages, which start at $1,599.99 with a hearing test and service visits included.
What the price difference buys
An OTC price usually covers the devices, an app or presets, and whatever remote support the maker offers; the OTC list shows each seller's trial and warranty. A fitted price covers a person who programs the aids to a hearing test and adjusts them later; the provider network page shows exactly what one seller includes and charges extra for.
Sources
- FDA: OTC Hearing Aids: What You Should Know
- eCFR 21 CFR 800.30
- Seller prices: every model page links its seller and date. Checked October 20, 2026.
The FDA's page lists “red flag” conditions that call for a doctor before using an OTC device. This guide compares rules and prices only.
Questions
Who can buy OTC hearing aids?
Adults with perceived mild to moderate hearing loss, under 21 CFR 800.30; the minimum age is in the table on this page. Younger buyers need a prescription.
How much cheaper are OTC hearing aids?
On this site the median OTC starting price is compared with the median provider-fitted starting price in the table on this page; both come from seller-printed prices on the check date.