Warning to Hearing Instrument Dispensers
A hearing device 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).]
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