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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-
counter hearing aids are only for users who are 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. Hearing 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 months
• You 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
WARNING: This hearing aid should not cause pain when inserting it.
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 instructions. If you feel
pain or discomfort again, contact the manufacturer. If you pain or discomfort
does not 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.
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