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devices. For this reason, the FDA
helped develop a detailed test
method to measure Electro
Magnetic Interference (EMI) of
implanted cardiac pacemakers
and defibrillators from wireless
telephones. This test method is
now part of a standard sponsored
by the Association for the
Advancement of Medical
Instrumentation (AAMI). The final
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
defibrillators 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
specifies 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
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