Do I Need a Prescription for a Hearing Aid? OTC vs Prescription Explained

If you've been putting off addressing your hearing loss because you assumed you'd need a doctor's appointment, a hearing test, and a prescription — you may be working with outdated information.

The rules changed in 2022. Here's what you need to know.

The 2022 FDA Rule Change

In October 2022, the FDA established a new category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. This rule change means:

• No prescription required
• No audiologist visit required
• No hearing test required (though one is still recommended)
• Available directly from retailers and online

This was a significant shift. Before 2022, all hearing aids required a prescription and had to be fitted by a licensed hearing professional. The OTC category was created specifically to improve access and reduce cost for the millions of Americans with untreated mild to moderate hearing loss.

OTC vs Prescription Hearing Aids: Key Differences

Who Can Use OTC Hearing Aids?

OTC hearing aids are designed for adults 18 and older with mild to moderate hearing loss. Signs your hearing loss may be in this range:

• You can hear people speaking but struggle to understand them clearly
• You frequently ask people to repeat themselves
• You have difficulty following conversations in noisy environments
• You turn up the TV louder than others prefer
• You miss parts of phone conversations

When Should You See an Audiologist Instead?

OTC hearing aids are not appropriate for everyone. Consult a hearing professional if:

• You have severe or profound hearing loss
• Your hearing loss came on suddenly (within 72 hours)
• You have hearing loss in only one ear
• You have pain, drainage, or bleeding from your ear
• You are under 18 years old
• You've tried OTC hearing aids and they haven't helped

Are OTC Hearing Aids as Good as Prescription?

For mild to moderate hearing loss: often yes.

Multiple studies and real-world comparisons have found that quality OTC hearing aids perform comparably to prescription devices for users in the mild to moderate range. What OTC devices offer: dramatically lower cost, immediate availability, and the ability to try and return without a clinic appointment.

How to Choose an OTC Hearing Aid

Step 1: Confirm you're in the OTC range
If you've had a recent hearing test, check whether your loss falls in the mild to moderate range.

Step 2: Choose the right style

• CIC (Completely-in-Canal) like the RKEPIE M602 — discreet, ideal for glasses wearers, mild to moderate loss
• BTE (Behind-the-Ear) like the RKEPIE M802 — easier to handle, stronger amplification, longer battery life

Step 3: Look for FDA registration
Legitimate OTC hearing aids are registered with the FDA. Avoid unregistered amplifiers marketed as hearing aids.

Step 4: Prioritize return policy
A 30–45 day return window is essential. Hearing aids require an adjustment period, and the right to return removes financial risk.

The Bottom Line

You do not need a prescription to buy a hearing aid in the United States if you are an adult with mild to moderate hearing loss. The 2022 FDA rule change made quality hearing aids accessible without a clinic visit.

The RKEPIE M602 CIC and RKEPIE M802 BTE are both FDA-registered OTC hearing aids available without a prescription, with a 45-day return policy and free shipping.

Ready to try? Both models ship directly to your door — no appointment, no prescription, no waiting room.