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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.
A hearing aid will not restore normal hearing and will not prevent or improve a
hearing impairment resulting from organic conditions. Use of a hearing aid is
only part of hearing habilitation and may need to be supplemented by auditory
training and instruction in lip reading. In most cases infrequent use of a hearing
aid does not permit a user to attain full benefit from it.
CHILDREN WITH HEARING LOSS.
In addition to seeing a physician for
a medical evaluation, 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
6700 Washington Avenue South
Eden Prairie, MN 55344
Starkey European Headquarters
Wm. F. Austin House, Bramhall Technology Park
Pepper Road, Hazel Grove, Stockport SK7 5BX
United Kingdom
www.starkey.com
fda infOrMatiOn
required 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.
RF IMMUNITY LEVEL.
These hearing instruments have a cell phone
immunity rating of M4. For your cell phone to be compatible with these hearing
instruments, the cell phone needs an immunity rating of M1 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 otorhynolaryngologists. 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.
