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Safety Guidelines
(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
42
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.

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