Direct comparison
OTC vs Prescription Hearing Aids: FDA Rules
OTC vs prescription hearing aids: who each is for, age and hearing-loss limits, package marks, return policy and red flags, from FDA and 21 CFR 800.30.
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Last updated
How do OTC hearing aid and Prescription hearing aid compare side by side?
The table below compares OTC hearing aid and Prescription hearing aid across 11 dimensions, from intended users to when to pick each.
Side-by-side comparison
| Dimension | OTC hearing aid | Prescription hearing aid |
|---|---|---|
| Intended users | Adults 18 and older with perceived mild to moderate hearing loss (21 CFR 800.30 definition). | Any hearing aid that is not an OTC hearing aid. FDA says these may suit all levels of hearing loss and all ages, based on the indications for use. |
| Degree of hearing loss | Mild to moderate only. FDA says OTC aids are not for severe or profound loss and may not give adequate benefit for it. | FDA says they may be appropriate for all levels of hearing loss. |
| Age | Sale to or for a person younger than 18 is prohibited, and the package must warn against use under 18 (21 CFR 800.30). | FDA: anyone under 18 needs to buy hearing aids by prescription and should see a doctor, preferably an ENT. |
| How it is obtained | In a store or online, with no prescription. FDA also notes they can be bought from a hearing health care professional. | Only through a licensed hearing health care professional (FDA). |
| Professional involvement at purchase | None required: no medical exam, prescription or fitting adjustment by an audiologist is needed (FDA). | A licensed professional programs the device to the person's level of hearing loss (FDA). |
| Who customizes it | The user, through tools, tests or software that let them control and customize the device (21 CFR 800.30). | The licensed professional, who programs it (FDA). Professionals can also perform a hearing test and hearing aid evaluation (FDA). |
| Package marks you can check | The principal display panel must bear "OTC" and "hearing aid". The outside package must carry a warning against use under 18, advice that professional services are available, "red flag" conditions, contact information and the manufacturer's return policy (21 CFR 800.30). | These OTC package requirements apply to OTC aids. A hearing aid that does not satisfy them is a prescription hearing aid (21 CFR 800.30). |
| Return policy and warranty | The package must state the manufacturer's return policy. FDA's OTC rules do not require a warranty, so any return or warranty period is set by the manufacturer (FDA). | The OTC return-policy notice in 21 CFR 800.30 applies to OTC packaging. |
| Regulatory basis | Defined in 21 CFR 800.30 as an air-conduction hearing aid that does not require implantation or other surgical intervention. The OTC category took effect October 17, 2022. | Defined by exclusion: hearing aids that do not satisfy 21 CFR 800.30 are prescription hearing aids. |
| Signs that point to a professional | OTC labeling lists "red flag" conditions that say to see a doctor, preferably an ENT: ear birth defect or unusual shape; ear injury; blood, pus or fluid from the ear in the past 6 months; ear pain or discomfort; a lot of ear wax or something in the ear; vertigo; sudden hearing change in the past 6 months; hearing that fluctuates; worse hearing in one ear; ringing or buzzing in only one ear. | FDA says to see a doctor, preferably an ENT, for these conditions. Prescription aids are obtained through a licensed hearing health care professional. |
| When to pick each | Consider an OTC aid if you are an adult with perceived mild to moderate hearing loss and none of the red flag conditions apply. | Use the professional route if you are under 18, suspect severe or profound loss, or any red flag condition applies. |
Sources
- FDA, "OTC Hearing Aids: What You Should Know" (content current as of 05/03/2023; read 2026-10-31). 21 CFR 800.30 via Cornell LII (read 2026-10-31)
- Same two sources
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Common questions
Common questions about OTC hearing aid vs Prescription hearing aid
Is an OTC hearing aid FDA-regulated?
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Yes. FDA established the OTC hearing aid category, which took effect on October 17, 2022, and 21 CFR 800.30 defines the product and sets its labeling requirements. An OTC aid is an air-conduction hearing aid that does not require implantation or other surgical intervention, intended for adults 18 and older with perceived mild to moderate hearing loss.
Can anyone under 18 buy an OTC hearing aid?
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No. 21 CFR 800.30 prohibits sale to or for a person younger than 18, and the package must warn against use under 18. FDA says people under 18 need a prescription hearing aid and should see a doctor, preferably an ENT.
Do I need a hearing test before buying an OTC hearing aid?
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No. FDA says OTC aids are sold without a medical exam, prescription or fitting adjustment by an audiologist. FDA also says you can buy them from a hearing health care professional, who can perform a hearing test and hearing aid evaluation.
Is a prescription hearing aid a different kind of device?
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FDA describes a prescription hearing aid as any hearing aid that is not an OTC hearing aid, and 21 CFR 800.30 says hearing aids that do not satisfy its OTC requirements are prescription hearing aids. The distinction is intended users, labeling and how the device is obtained.
Does an OTC hearing aid come with a warranty?
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Not necessarily. FDA says its OTC hearing aid regulations do not require a warranty, but the package must state the manufacturer's return policy.
Going deeper
