4 | Warnings, Cautions, & Notices Warnings, Cautions, & Notices | 5
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 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 email 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, 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.
The audiologist will conduct a hearing aid evaluation to assess
the person’s ability to hear with and without a hearing aid. This
will enable the audiologist to select and fit a hearing aid for
the person’s individual needs. An audiologist can also provide
evaluation and rehabilitation since, for people younger than
18, hearing loss may cause problems in language development
and educational and social growth. An audiologist is qualified
by training and experience to assist in the evaluation and
rehabilitation of hearing loss in people younger than 18.
IMPORTANT NOTICE FOR PROSPECTIVE Rx HEARING AID
USERS:
It is good health practice for a person with a hearing loss to
have a medical evaluation by a licensed physician (preferably a
physician who specializes in diseases of the ear) before purchasing
a prescription hearing aid. Licensed physicians who specialize
in diseases of the ear are often referred to as otolaryngologists,
otologists or otorhinolaryngologists. The purpose of the medical
evaluation is to assure that all medically treatable conditions that
may affect hearing are identified and treated before the hearing
aid is purchased.
Following the medical evaluation, the physician will give you a
written statement that states that your hearing loss has been
medically evaluated and that you may be considered a candidate
for a hearing aid. The physician will refer you to an audiologist or
hearing aid dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid
evaluation to assess your ability to hear with and without a hearing
aid. The hearing aid evaluation will enable the audiologist or
dispenser to select and fit a hearing aid to your individual needs.
If you have reservations about your ability to adapt to
amplification, you should inquire about the availability of a trial-
rental or purchase option program. Many hearing aid dispensers
now offer programs that permit you to wear a hearing aid for a
period of time for a nominal fee after which you may decide if you
want to purchase the hearing aid.
In some geographies, you must have a medical evaluation before
purchasing a prescription hearing aid. Some states allow an adult
to waive the medical evaluation.
