Audibel invisibel anthem xt, 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 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 .

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 .