FDA Warnings, Cautions & Notes for all OTC Hearing Aids

BOXED WARNING: If you are younger than 18, do not use this

You should go to a doctor, preferably an ear-nose-throat doctor (an ENT), because your condition needs specialized care. Over-the-counter (OTC) hearing aids are only for users who are age 18 or older.

 

This OTC hearing aid is for users who are 18 and older. People who are younger than 18 with hearing loss should see a doctor, preferably an ENT, because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.

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WARNING: When to see a doctor

If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).

• Your ear has a birth defect or unusual shape. Your ear was injured or deformed in an accident

• You saw blood, pus, or fluid coming out of your ear in the past 6 months

• Your ear feels painful or uncomfortable

• You have a lot of ear wax, or think something could be in your ear

• You get really dizzy or have a feeling of spinning or swaying (called vertigo)

• Your hearing changed suddenly in the past 6 months

• Your hearing changes: it gets worse then gets better again

• You have worse hearing in one ear

• You hear ringing or buzzing in only one ear

 

WARNING: This hearing aid should not cause pain when inserting it

Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’t go away, contact your hearing healthcare professional. You can also report this to the FDA as an adverse event according to the instructions that appear later.

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Caution: This is not hearing protection

You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.

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Caution: The sound output should not be uncomfortable or painful

You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, you may need to further adjust your device.

Caution: You might need medical help if a piece gets stuck in your ear

If any part of your hearing aid, like the eartip, gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabs because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.

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Note: If you remain concerned, consult a professional

If you try this device and continue to struggle with or remain concerned about your hearing, you should consult with a hearing healthcare professional.

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Note: What you might expect when you start using a hearing aid

A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, and you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or improve a medical condition that causes hearing loss.

People who start using hearing aids sometimes need a few weeks to get used to them. Similarly, many people find that training or counseling can help them get more out of their devices.

If you have hearing loss in both ears, you might get more out of using hearing aids in both, especially in situations that make you tired from listening - for example, noisy environments.

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Note: Tell FDA about injuries, malfunctions, or other adverse events

To report a problem involving your hearing aid, you should submit information to FDA as soon as possible after the problem. FDA calls them “adverse events,” and they might include: skin irritation in your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of the device getting stuck in your ear, suddenly worsening hearing loss from using the device etc.