Warnin g to Hearing Instrume nt Dispensers (to comply with the U.S. Food and Drug Administrat ion (FDA) regulations)
A hearinginstrument dispenser should advise a prospective hearing instrument user to consult promptly with a licensed physician (preferablyan ear specialist) before dispensinga hearing instrumentif the hearinginstrument dispenser determines through inquiry,actualobservation, or reviewof any other available informationconcerningthe prospective user, that the prospectiveuser has any of the following conditions:(i) Visiblecongenitalor traumatic deformity of the ear. (ii) History of activedrainagefrom the ear within the previous90 days. (iii)History of suddenor rapidly progressive hearingloss within the previous
90 days. (iv) Acute or chronicdizziness. (v) Unilateral hearing loss of sudden or recent onset withinthe previous 90 days. (vi)
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