For The Us Market Only, Complies With The Fda Regulations - Sonova Phonak Audeo M-13T User Manual

21. For the US market only, complies
with the FDA regulations
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 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:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within
the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss
within the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset
within the previous 90 days.
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