User's Manual

49
FDA Information
Federal law restricts the sale of hearing instruments 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. 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 in impairing the remaining
hearing of the hearing aid user.
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.