Warning To Hearing Aid Dispensers - OTOFONIX Helix User Manual

Warning to Hearing Aid Dispensers

A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed
physician (preferably an ENT specialist) before dispensing a hearing aid, if the hearing aid 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:
• Acute or chronic dizziness or vertigo
• Pain or discomfort in the ear
• Visible congenital or traumatic deformity of the ear
• History of active drainage from the ear within the previous 90 days
• History of sudden or rapidly progressive hearing loss within the previous 90 days
• Unilateral hearing loss (hearing loss in both ears) of sudden or recent onset within the previous 90 days
• Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1000 Hz, and 2000 Hz
• Visible evidence of significant cerumen (earwax) accumulation or a foreign body in the ear canal
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