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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 rst, 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.
• The doctor may refer the person to an audiologist for a
separate test, a hearing aid evaluation.
• The hearing aid evaluation will help the audiologist select
and t the appropriate hearing aid.
A person who is younger than 18 years old with hearing
loss should have a medical evaluation by a doctor, preferably
an ENT, before buying a hearing aid. The purpose of a medical
evaluation is to identify and treat medical conditions that may
affect hearing but that a hearing aid won’t treat on its own.
Following the medical evaluation and if appropriate, the
doctor will provide a written statement that the hearing loss
has been medically evaluated and the person is a candidate
for a hearing aid. The doctor may refer the person to an
FDA Required Information
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