Note: Tell the FDA about injuries, malfunctions, or other
adverse events.
To report an adverse event, you should
submit the information to FDA as soon as possible after
the event. Adverse events can include: ear canal or
outer ear skin irritation, injury from the device (like cuts
or scratches, or burns from an overheated battery),
pieces of the device lodged in your ear canal, sudden
increased severity in hearing loss with device use, etc.
Instructions for reporting are available at
www.fda.gov/
Safety/MedWatch
, or call
1-800-FDA-1088.
aids) may provide more benefit than just one hearing
aid, especially in demanding listening situations - for
example, noisy environments.
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