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RXEARS RXS - Important Notices and FDA Statements

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16
Important notice for prospective hearing
instrument users (FDA required statement)
Good health practice requires that a person with a hearing
loss have a medical evaluation by a physician (preferably
a physician who specializes in diseases of the ear) before
purchasing a hearing instrument. Licensed physicians who
specialize in diseases of the ear are often referred to as
otolaryngologist, otologists or otorhinolaryngologists. The
purpose of medical evaluation is to assure that all medically
treatable conditions that may aect hearing are identied
and treated before the hearing instrument is purchased.
Allergies
The materials used in making your hearing instrument are
of the highest quality available. The likelihood of an allergic
reaction is slight. If an allergic reaction should occur, it
may take the form of skin irritation. If a reaction occurs, we
strongly suggest that you discontinue use and contact your
physician.
Children
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. Hearing loss may cause
problems in speech and language development and the
educational and social growth of the child.
Message to Dispenser (FDA required statement)
A hearing instrument dispenser should advise a prospective
hearing instrument user to consult promptly with a licensed
physician (preferably an ear Specialist) before dispensing
a hearing instrument if the dispenser determines through