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33
wireless telephones. This
test method is now part
of a standard sponsored
by the Association for the
Advancement of Medical
instrumentation (AAMI).
The fi nal draft, a joint
effort by the FDA, medical
device manufacturers, and
many other groups, was
completed in late 2000.
This standard will allow
manufacturers to ensure
that cardiac pacemakers
and defi brillators are safe
from wireless phone EMI.
The FDA has tested hearing
aids for interference from
handheld wireless phones
and helped develop
a voluntary standard
sponsored by the Institute
of Electrical and Electronic
Engineers (IEEE). This
standard specifi es test
methods and performance
requirements for hearing
aids and wireless phones
so that no interference
occurs when a person
uses a ‘compatible’ phone
and a ‘compatible’ hearing
aid at the same time. This
standard was approved
by the IEEE in 2000. The
FDA continues to monitor
the use of wireless phones
for possible interactions
with other medical devices.
Should harmful interference
be found to occur, the FDA
will conduct testing to
assess the interference and
work to resolve the problem.
12. Where can I
fi nd additional
information?
For additional information,
please refer to the following
resources: