Warning To Hearing Aid Dispensers (To Comply With The U.s. Food And Drug Administration (Fda) Regulations) - Sonova Unitron Moxi Jump R Series Manual

Warning to hearing aid dispensers (to comply with
the U.S. Food and Drug Administration (FDA)
regulations)
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. 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. [This
provision is required only for those hearing aids with a maximum
sound pressure capability greater than 132 decibels (dB).]
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.
52
The purpose of 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 a 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 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.
53