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tweak ENHANCE - Hearing Aid Should Not Cause Pain; Active Implantable Devices; Electromagnetic Testing; Not Hearing Protection

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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.
WARNING: You have active implantable devices.
If you have active implantable devices (such as a pacemaker), keep magnets (charging base) at least 6
inches away from the active implant. Tweak recommends you always follow the guidelines of the implant
manufacturer. If you suspect any interference to your implant, immediately discontinue use of electronic
devices, including hearing aids. Contact implant manufacturer and Tweak Hearing to report the suspected
interference.
WARNING: Electromagnetic testing
Prior to any CT, MRI scans or other electromagnetic procedure, remove your hearing aids.
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.
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.