Indications For Use - HP Hearing PRO User Manual

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 counselling can help them
get more out of their devices.
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 1800-FDA-1088.
You can download a form to mail to FDA.
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Indications for use

The HP Hearing PRO Self-Fitting OTC Hearing Aids are
intended to amplify sound for individuals 18 years of
age or older with perceived mild to moderate hearing
impairment. They are adjusted by the user to meet the
user's hearing needs. No pre-programming or hearing
test is necessary. The device is intended for direct-to-
consumer sale and use without the assistance of a
hearing care professional.
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