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Compliance Information
Warning to Hearing Device Dispensers
A hearing device dispenser should advise a prospective hearing device user to consult promptly with a licensed physician
(preferably an ear specialist) before dispensing a hearing device if the hearing device 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. (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. Special care should be exercised in selecting and fitting a hearing device whose maximum sound
pressure level exceeds 132 decibels* because there may be risk of impairing the remaining hearing of the hearing device
user.
*The Lumen 155 does not exceed 132 decibels
Summary of Contents for Lumen 155
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