
Safety and health information
CAUTION: You might need medical help if a piece gets stuck in your ear.
If any part of your hearing aid, like the eartip (dome), gets stuck in your
ear, and you can’t easily remove it with your ngers, 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.
Note: What you might expect when you start using a hearing aid.
A hearing aid can benet many people with hearing loss. However, you
should know it will not restore normal hearing, and you may still have
some difculty 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 nd 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 ears, 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.
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: Any harm caused by the device or any dissatisfaction using the
device must be reported to Hearing Help Express.
or write to: Hearing Help Express, PO Box 586, DeKalb, IL 60115.
Intended Use:
The EarMate®-4330 is an air-conduction hearing aid intended to
compensate for impaired hearing for individuals who are 18 years of age
and older with perceived mild to moderate hearing loss. This device is
intended for use without the assistance of a hearing care professional.
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