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FDA Information
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 All
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 otorhinolaryngologists. The purpose of 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
Information Cont’d
Содержание HearClear HCR3
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