Operation Manual

28
FDA Information
Required Information
The following additional information is provided in compliance with
U.S. Food and Drug Administration (FDA) regulations:
WARNING TO HEARING INSTRUMENT DISPENSERS. A hearing
instrument dispenser should advise a prospective hearing instrument user
to consult promptly with a licensed physician (preferably an ear specialist)
before dispensing a hearing instrument if the hearing instrument
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.
Special care should be exercised in selecting and fitting a hearing
instrument whose maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining hearing of the
hearing instrument user.
RF IMMUNITY LEVEL. These hearing instruments have a cell phone
immunity rating of M4/T4. For your cell phone to be compatible with
these hearing instruments, the cell phone needs an immunity rating of
M1/T1 or higher. Please consult your cell phone specifications for your
cell phone immunity rating.
IMPORTANT NOTICE FOR PROSPECTIVE HEARING INSTRUMENT
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 instrument. Licensed physicians who specialize in diseases
of the ear are often referred to as otolaryngologists, otologists, or
otorhynolaryngologists. 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 instrument is purchased.