4
However, you should know it will not restore normal
hearing, and you may still have some difficulty hearing over
noise. Further, a hearing aid will not prevent or improve a
medical condition that causes hearing loss.
People who start using hearing aids sometimes need a few
weeks to get used to them. Similarly, many people find that
training or counseling can help them get more out of their
devices.
If you have hearing loss in both ears, you might get more
out of using hearing aids in both, especially in situations
that make you tired from listening – for example, noisy
environments.
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.
Note: Hearing loss in people younger than 18
•
People younger than 18 should see a doctor first,
preferably an ear-nose-throat doctor (an ENT), because
they may have different needs than adults.
• The doctor will identify and treat medical conditions as
appropriate.
FDA Required Information
