Over-The-Counter Hearing Aids

The term 'hearing aid' has, up until now, referred to prescription hearing aids, which can only be purchased through a licensed provider, such as an audiologist.

The Federal Drug Adminstration's (FDA) action introduces a new class, OTC hearing aids, that can be purchased without a prescription and may provide many of the benefits attributed to prescription hearing aids.

The OTC hearing aid announcement from the FDA states "This action enables consumers 18 years of age and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist." Click Here for additional information on the FDA announcement.

HLAA’s OTC Tip Sheet

You may have mild to moderate hearing loss if...

• You have trouble understanding conversations in groups with background noise, or when you can’t see who is talking. notes...

• You have trouble hearing on the telephone. notes...

• You need to turn up the volume of television, or radio loud enough for others to complain. notes...

• Your friends or family complain that you don’t understand speech, and ask them to repeat often. notes...

OTC may NOT help you if...

• You also have trouble hearing conversations in quiet environments.

• You also have trouble hearing loud sounds like power tools, or motor vehicles.

If you experience hearing difficulty in these situations, you should see a hearing care professional.

Important questions to ask about OTC hearing aids

• Is there a free trial period, or money back return policy? notes...

• Does it need a smartphone, app, or computer to install, operate, and customize to my needs?notes...

• Is it compatible with cellphones, or smartphones? notes...

• Does it have connectivity via Bluetooth, or telecoil to a smartphone, computer, or listening system? notes...

• Can the hearing aid’s amplification be adjusted? notes...

• Is it water/sweat resistant? notes...

• How does it control, reduce, or block out background, or wind noise? notes...

• How long is the battery life? Can it be recharged? notes...

Other Considerations

• Pay attention to package warnings. If you have pain, sudden hearing changes, or dizziness, see a doctor.

• It may take time to adjust to hearing devices.

• If the first hearing aid doesn’t work, keep trying, and you may want to seek the help of a hearing care professional to advise you.

View Tip Sheet print-friendly PDF

Important: check the box for the "OTC" label. If it is not present the product likely does not meet the FDA requirements for OTC hearing aids and you might consider looking for a different product.

Also see HLAA Hearing Loss Basics for more information on hearing and hearing loss.