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 concern-
ing 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 aid whose maximum
sound pressure level exceeds 132 decibels because there may be risk of impairing the
remaining hearing of the hearing aid user.
RF IMMUNITY LEVEL.These hearing instruments have a cell phone immunity rating
of M2. For your cell phone to be compatible with these hearing instruments, the cell
phone needs an immunity rating of M3 or higher. Please consult your cell phone
specifications for your cell phone immunity rating.
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.
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FDA REQUIRED INFORMATION
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
personal beliefs that preclude consultation with a physician. The exercise of such a
waiver is not in your best health interest and its use is strongly discouraged.
cHILDREN WITH HEARING LOSS. In addition to seeing a physician for a medical eval-
uation, a child with a hearing loss should be directed to an audiologist for evaluation
and rehabilitation since hearing loss may cause problems in language development and
the educational and social growth of a child. An audiologist is qualified by training and
experience to assist in the evaluation and rehabilitation of a child with a hearing loss.
© Starkey World Headquarters
P.O. Box 9457, Minneapolis, MN 55440
Wm. F. Austin House, Bramhall Technology Park, Pepper Road, Hazel
Grove, Stockport SK7 5BX, United Kingdom
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FDA REQUIRED INFORMATION