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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.
RF IMMUNITY LEVEL.
These hearing instruments have a cell phone
immunity rating of M4. For your cell phone to be compatible with these hearing
instruments, the cell phone needs an immunity rating of M1 or higher. Please
consult your cell phone specifications for your cell phone immunity rating.
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 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 aid is purchased.
