27
Warning to Hearing Instrument
Dispensers
A hearing instrument dispenser should advise a
prospective hearing device user to consult promptly with
a licensed physician (preferably an ear specialist) before
dispensing a hearing device if the hearing device
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
device whose maximum sound pressure level exceeds
132 decibels because there may be risk of impairing the
remaining hearing of the hearing device user. [This
provision is required only for those hearing devices with a
maximum sound pressure capability greater than 132
decibels (dB).]
