Miracle-Ear CONNECT 5/4 RIC 312 BL User Manual page 6

WARNINGS, CAUTIONS, & NOTICES
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 devices, 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
• 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 fit 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 audiologist for a
hearing aid evaluation, which is different from the medical evaluation and is intended
to identify the appropriate hearing aid.
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