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Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level
exceeds 132 decibels as there may be risk of impairing the remaining hearing of the hearing aid user. (This provision
is required only for those hearing aids with a maximum sound pressure capability greater than 132 decibels (dB)).
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.
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 ear tip, 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.
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.
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 aer 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.
Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
You can also download a form to mail to FDA.
Note: Hearing loss in people younger than 18
• People younger than 18 should see a doctor first, preferably an ear-nose-throat doctor (an ENT), because they may
have different needs than adults
• The doctor will identify and treat medical conditions as appropriate
• The doctor may refer the person to an audiologist for a separate test, a hearing aid evaluation
• The hearing aid evaluation will help the audiologist select and fit the appropriate hearing aid
