Warnings
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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-count-
er 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.Hear-
ing loss can affect speech and learning, so professional fitting and
continuing care are also important.
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 an 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
monthsYour ear feels painful or uncomfortable.
·Your ear feels painful or uncomfortable.
·You have a lot of ear wax, or you 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.
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 instruc-
tions. 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 FDA as an adverse
event according to the instructions that appear later.
WARNING: This hearing aid should not cause pain
when inserting it.
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