Starkey RIC 312, Operation Manual

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FDA Information
Required Information
The following additional information is provided in compliance with U.S.
Food and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS.
A hearing aid dispenser should advise a prospective hearing aid user to
consult promptly with a licensed physician (preferably an ear specialist)
before dispensing a hearing aid if the hearing aid dispenser determines
through inquiry, actual observation or review of any other available
information concerning the prospective user that the prospective user has
any of the following conditions:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing
loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous
90 days.
vi. Audiometric air-bone gap equal to or greater than
15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
vii. Visible evidence of significant cerumen accumulation or a foreign
body in the ear canal.
viii. Pain or discomfort in the ear.
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS.
Good health practice requires that a person with a hearing loss have a
medical evaluation by a licensed physician (preferably a physician who
specializes in diseases of the ear) before purchasing a hearing aid. Licensed
physicians who specialize in diseases of the ear are often referred to as
otolaryngologists, otologists or otorhynolaringologists. 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.