REGULATORY INFORMATION
The Widex Energy Cell™ technology is a micro fuel cell system and complies
with IEC 62282-6-100 and IEC 62282-6-100 A1.
Warning to hearing aid dispensers
A hearing aid dispenser should advise a prospective hearing aid user to con-
sult promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser determines through in-
quiry, actual observation, or review of any other available information con-
cerning the prospective user, that the prospective user has any of the fol-
lowing 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.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500
hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body
in the ear canal.
(viii) Pain or discomfort in the ear.
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