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ReSound KE461-DRWC - Warnings to Hearing Aid Dispensers (US only); Warnings for Hearing Aid Dispensers

ReSound KE461-DRWC
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Warnings to Hearing Aid Dispensers (US
only)
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a
licensed physician (preferably an ear 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:
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
2000Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
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