Note: Tell FDA about injuries, malfunctions, or other adverse events.
To report a problem involving your hearing aid, you should submit information to FDA as soon as
possible after the problem. FDA calls them “adverse events,” and they might include: skin irritation in
your ear, injury from the device (like cuts or scratches, or burns from an overheated battery), pieces of
the device getting stuck in your ear, suddenly worsening hearing loss from using the device, etc.
Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088.
You can also download a form to mail to FDA.
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