2.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).
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.
1.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 age 18 or older.
WARNING
● 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.
3.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.
4.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.
5.Caution: The sound output should not be uncomfortable or painful.
You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful.
If you consistently need to turn the volume down, you may need to further adjust your device.
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