User's Guide
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.
your hearing aids to another program, turn
your head in a different direction or locate
the cell phone and move away from it.
Labeling
The serial number and year of manufacture
are located inside the battery door.
38 39