Warning To Hearing Aid Dispensers (To Comply With The U.s. Food And Drug Administration (Fda) Regulations) - Unitron Quantum User Manual

Warning to hearing aid dispensers
(to comply with the U.S. Food and Drug
Administration (FDA) regulations)
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.
Special care should be exercised in selecting and fitting a hearing
aid whose maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining hearing
of the hearing aid user. [This provision is required only for those
hearing aids with a maximum sound pressure capability greater
than 132 decibels (dB).]
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.
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