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Warning to hearing instrument dispensers
A hearing instrument dispenser should advise a prospective hearing instrument user
to consult immediately with a licensed physician (preferably an ear specialist) before
dispensing a hearing instrument if the hearing instrument 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 signicant cerumen accumulation or a foreign body in the ear
canal.
(viii) Pain or discomfort in the ear.
Warnings
Special care should be exercised in selecting and tting a hearing instrument whose
maximum sound pressure capability exceeds 132 dB SPL as there may be risk of
impairing the remaining hearing of the hearing instrument user.
Important notice for prospective hearing instrument 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 instrument. 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 ensure that all
medically treatable conditions that may aect hearing are identied and treated
before the hearing instrument 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
instrument. The physician will refer you to an audiologist or a hearing instrument
dispenser, as appropriate, for a hearing instrument evaluation.
Warnings