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.
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.
Also if you experience side effects from wearing the hearing aids, contact a hearing healthcare professional.
Possible side effects may be: dizziness, tinnitus, perceived worsening of hearing loss, nausea, headache, skin
reaction, or excessive ear wax accumulation.
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 benefit from
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 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.
SYMBOL DESCRIPTIONS
Caution / Warning
This symbol indicates there
are specific precautions or
warnings associated with the
OTC hearing aids.
Important Information
This symbol indicates
important information about
handling and product safety.
Consult User Manual
for details about using the
OTC hearing aid.
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.
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