Miracle-Ear EarENERGY 5 RIC R EV User Manual page 24

Regulatory Information
Federal law restricts the sale of hearing aids to those individuals who have obtained
a medical evaluation from a licensed physician. Federal law permits a fully informed
adult to sign a waiver statement declining the medical evaluation for religious or
personal beliefs that preclude consultation with a physician. The exercise of such a
waiver is not in your best health interest and its use is strongly discouraged.
A hearing aid will not restore normal hearing and will not prevent or improve a
hearing impairment resulting from organic conditions. Use of a hearing aid is only
part of hearing habilitation and may need to be supplemented by auditory training
and instruction in lip reading. In most cases infrequent use of a hearing aid does not
permit a user to attain full benefit from it.
Some hearing aid users have reported a buzzing sound in their hearing aid when
they are using mobile phones, indicating that the mobile phone and hearing aid
may not be compatible. According to the ANSI C63.19 standard (ANSI C63.19-2007
American National Standard Methods of Measurement of Compatibility Between
Wireless Communications Devices and Hearing Aids), the compatibility of a particular
hearing aid and mobile phone can be predicted by adding the rating for the hearing
aid immunity to the rating for the mobile phone emissions. For example, the sum of
a hearing aid rating of 2 (M2/T2) and a telephone rating of 3 (M3/T3) would result
in a combined rating that equals at least 5 would provide "normal use"; a combined
rating of 6 or greater would indicate "excellent performance." See your Quick Start
Guide included with your hearing aids for their exact M/T ratings.
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Regulatory Information
CHILDREN WITH HEARING LOSS
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 since hearing
loss may cause problems in language development and the educational and social
growth of a child. An audiologist is qualified by training and experience to assist in
the evaluation and rehabilitation of a child with a hearing loss.
Required Custom Tinnitus
Miracle-Ear Hearing Care Professionals
®
INDICATIONS FOR USE
The Custom Tinnitus Technology is a tool to generate sounds to be used in a
™
Tinnitus Management Program to relieve patients suffering from tinnitus. The target
population is primarily the adult population over 18 years of age.
The Custom Tinnitus Technology is targeted for healthcare professionals, which are
™
treating patients suffering from tinnitus, as well as conventional hearing disorders.
The fitting of the Custom Tinnitus ™ Technology must be done by a Miracle-Ear
Hearing Care Professional participating in a Tinnitus Management Program.
Information for
™
®
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