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THE FINE PRINT
Hearing-Related Safety Applications
Although your hearing instrument is warranted, reflecting its design
quality and reliability, fail-safe reliability is not implied. The hearing
instrument should not be relied upon as a primary safety system
in any application where injury or loss of life may result from failure
of the hearing device to properly operate. No redundancy or back-
up is available in either the power source or the individual and
collective circuit functions of the instrument.
Important Notice From the FDA
For Prospective Listening device 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. 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 listening device dispenser, as appropriate, for a
hearing aid evaluation.
The audiologist or listening device 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.
