18
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. [This provision is required only for
those hearing instruments with a maximum sound
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