FDA Information
36
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.
Summary of Contents for BTE
Page 1: ...BTE Behind The Ear O P E R A T I O N S M A N U A L ...
Page 5: ...5 Rocker Switch BTE 312 and 13 Overview 7 8 4 00 000000 Serial Number 5 6 11 10 9 1 2 3 5 ...
Page 7: ...7 Control Surface BTE 312 and 13 Overview 2 3 11 10 9 4 00 000000 8 1 7 Serial Number 5 6 7 ...
Page 9: ...Preparation 1 2 3 4 5 9 ...
Page 13: ...Preparation 1 2 3 4 5 13 ...
Page 39: ...Notes 39 ...
