Ceretone LAMBDA L1X, Руководство пользователя

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In compliance with the FDA regulation’s (21 CFR 801.420(c)(3))
guidance on labeling requirements for the sale of air-conduction
hearing aids is the inclusion of the following notice:
Important Notice For Prospective Hearing Aid Users:
Good health practice requires that a person with a hearing loss have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists or otorhinolaryngologists. The purpose of the medical evaluation is
to assure that all medically treatable conditions that may affect hearing are
identified and treated before the hearing aid is purchased.
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.
(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.
FDA Requirements
FDA Labeling Requirements
Additionally, this is the FDA warning statement as provided in 21
CFR 801.420(c)(2), it states the following:
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