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, puss, 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.
• 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 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.
Caution: This is not hearing protection.
You should remove this device if you experience
overly loud sounds, whether short or long-lasting.
If you’re in a loud place, you should use the right
kind of hearing protection instead of wearing this
device. In general, if you would use ear plugs in a
loud place, you should remove this device and use
ear plugs.
