FDA warnings and cautions
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 (OTC) 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. 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
•
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
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