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Should you develop any side effects whilst
using the noise generator such as headaches,
nausea, dizziness or heart palpitations or
experience a decrease in auditory function, you
should discontinue use and seek a medical
evaluation.
According to OSHA (Occupational Safety &
Health Administration, U.S. Department of
Labor) regulations, the volume of the noise
generator can be set to a level which could lead
to permanent hearing damage when used for
a prolonged period of time. Should the noise
generator be set to such a level in your hearing
aid, your hearing healthcare professional will
advise you of the maximum amount of time
per day you should use the noise generator.
The noise generator should never be used at
uncomfortable levels.
!
Air conduction hearing aids with the tinnitus
masker are to be fitted by a hearing care
professional familiar with the diagnosis and
management of tinnitus.
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).]