Miracle-Ear EarENERGY 5 BTE R EV User Manual page 23

Regulatory Information
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food and
Drug Administration (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.
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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Regulatory Information
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
otorhynolaringologists. 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.
Following the medical evaluation, the physician will give you a written statement
that states that your hearing loss has been medically evaluated and that you may
be considered a candidate for a hearing aid. The physician will refer you to an
audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to
assess your ability to hear with and without a hearing aid. The hearing aid evaluation
will enable the audiologist or dispenser to select and fit a hearing aid to your
individual needs.
If you have reservations about your ability to adapt to amplification, you should
inquire about the availability of a trial-rental or purchase-option program. Many
hearing aid dispensers now offer programs that permit you to wear a hearing aid for
a period of time for a nominal fee after which you may decide if you want to purchase
the hearing aid.
Federal law restricts the sale of hearing aids to those individuals who have obtained
a medical evaluation from a licensed physician. Federal law permits a fully informed
adult to sign a waiver statement declining the medical evaluation for religious or
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