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1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15dB at 500 hertz (Hz), 1000 Hz, and 2000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
i
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.
400618011US-17.01-Rev.A.indd 52 25-01-2017 09:59:16