Do You Need a Prescription for Hearing Aids? OTC vs. Prescription Explained

Do You Need a Prescription for Hearing Aids?

In the United States, adults aged 18 or older with perceived mild to moderate hearing difficulty can purchase OTC (over-the-counter) hearing aids without a prescription, audiologist visit, or hearing test. This has been the case since October 2022, when the FDA established a new OTC hearing aid category.

Prescription hearing aids still exist and remain appropriate for some users. Whether you need a prescription depends on your situation, not just your preference.

What Changed With the FDA OTC Hearing Aid Rule?

Before October 2022, all hearing aids in the United States required a prescription and had to be fitted by a licensed hearing professional. The FDA rule created a separate OTC category to improve access for adults with mild to moderate hearing difficulty who do not need professional fitting.

• OTC hearing aids are FDA-regulated medical devices that must meet specific safety and labeling requirements.
• FDA regulation means the device meets federal requirements for the OTC category. It does not guarantee effectiveness for any individual user.
• OTC hearing aids are self-fitted by the user through volume controls or adjustable settings.
• They are available online and in retail stores without a prescription.

Who Can Buy OTC Hearing Aids?

OTC hearing aids are intended for adults aged 18 or older who perceive themselves to have mild to moderate hearing difficulty. Common experiences in this range include frequently asking people to repeat themselves, difficulty following conversations in noisy environments, turning the TV up higher than others prefer, or difficulty understanding phone calls.

OTC hearing aids are not appropriate for children under 18, adults with severe or profound hearing difficulty, or anyone whose hearing difficulty requires professional diagnosis or specialized fitting. For more on what degree of hearing difficulty typically benefits from a hearing aid, see our hearing loss level guide.

OTC vs. Prescription Hearing Aids

When a Prescription or Professional Evaluation May Be Appropriate

A professional hearing evaluation is the most reliable way to understand your hearing. It is particularly important if you experience any of the following, and an OTC hearing aid is not the right first step in these cases:

• A sudden change in hearing
• Hearing difficulty that is significantly worse in one ear
• Ear pain, discharge, or a feeling of fullness
• Severe dizziness or vertigo
• Tinnitus that pulses in time with your heartbeat
• Hearing difficulty in a child under 18

These symptoms may indicate a medical condition that requires evaluation before any hearing device is considered. Adults with severe or profound hearing difficulty should seek professional care rather than an OTC device. Even without these symptoms, a professional audiogram gives you accurate information that self-assessment cannot provide.

What OTC Hearing Aids Can and Cannot Do

OTC hearing aids can:

• Amplify sound to support hearing in everyday situations
• Help with conversations, TV listening, and phone calls for appropriate users
• Provide an accessible option without a clinic visit or prescription

OTC hearing aids cannot:

• Replace a professional audiogram or diagnosis
• Address severe or profound hearing difficulty
• Guarantee the same outcome as a professionally fitted prescription device for all users
• Cure or reverse hearing loss

For a fuller overview, see our OTC hearing aid guide. To understand the difference between OTC hearing aids and sound amplifiers, see our hearing aid vs. sound amplifier guide.

How to Choose Your Next Step

• If you have perceived mild to moderate hearing difficulty and are 18 or older: An OTC hearing aid is a reasonable starting point. No prescription or clinic visit is required.
• If you have symptoms that warrant medical evaluation: See a physician or hearing professional before purchasing any hearing device.
• If you want an accurate picture of your hearing: A professional audiogram is the most reliable option, even if you ultimately choose an OTC device.
• If you have severe or profound hearing difficulty, or have tried OTC and found it insufficient: A prescription hearing aid from a licensed provider is the more appropriate path.

For guidance on what to look for in an OTC hearing aid, see our hearing aid buying guide.

Frequently Asked Questions

Can I buy a hearing aid without seeing a doctor?

Yes, if you are 18 or older with perceived mild to moderate hearing difficulty. OTC hearing aids are available without a prescription or doctor's visit. However, if you have any of the symptoms listed above, a medical evaluation should come first.

Are OTC hearing aids as effective as prescription ones?

For some adults with mild to moderate hearing difficulty, OTC hearing aids provide comparable benefit to prescription devices. For others, particularly those with more complex hearing profiles or who need precise audiogram-based programming, a prescription device may perform better. Results vary between individuals.

Do I need a hearing test before buying an OTC hearing aid?

A hearing test is not required to purchase an OTC hearing aid. However, a professional audiogram is the most reliable way to confirm that your hearing difficulty falls within the OTC range and to rule out conditions that require medical attention.

Are OTC hearing aids FDA approved?

OTC hearing aids are regulated by the FDA as medical devices under the category established in 2022. They must meet specific safety and labeling requirements. FDA regulation is not the same as FDA approval of effectiveness for any individual user.

The Bottom Line

Adults aged 18 or older with perceived mild to moderate hearing difficulty do not need a prescription to purchase a hearing aid in the United States. The FDA OTC hearing aid category makes it possible to access hearing support without a clinic visit.

If you are ready to explore OTC options, our hearing aid buying guide explains what to look for. RKEPIE offers both CIC and BTE styles: M602 CIC, M802 BTE, and M905 BTE, all with a 45-day return policy.