6. Audiometric air-bone gap equal to or greater than 15 dB at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal
8. Pain or discomfort in the ear.
CAUTION: The maximum output of the sound generator falls into the range that can cause hear-
ing loss according to OSHA regulations. In accordance with NIOSH recommendations, the user
should not use the sound generator for more than eight (8) hours a day when set to a level of 85
dB SPL or above. When the sound generator is set to levels of 90 dB SPL or above, the user should
not use the sound generator for more than two (2) hours per day. In no case should the sound
generator be worn at uncomfortable levels.