14
15
(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.
CAUTION: The maximum output of the sound generator falls into the range that can
cause hearing loss according to OSHA regulations. The user should not use the sound
generator for more than eight (8) hours a day when this is set below 90dB SPL. Above that
level, the device should not be used for more than two (2) hours per day. In no case should
the sound generator be worn at uncomfortable levels.
WaRning To HeaRing CaRe PRaCTiTioneR
A hearing care practitioner should advise a prospective sound generator user to consult
promptly with a licensed physician (preferably an ear specialist) before setting a sound
gene rator if the hearing care practitioner determines through inquiry, actual observation, or
review or any other available information concerning the prospective user that the prospec-
tive 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.
