User's Manual

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devices. For this reason, FDA helped develop a detailed test method to measure
electromagnetic 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 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. 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 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. FDA continues to monitor the use of wireless phones for
possible interactions with other medical devices. Should harmful interference be found
to occur, FDA will conduct testing to assess the interference and work to resolve the
problem.
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12. Where can I find additional information?
For additional information, please refer to the following resources:
FDA web page on wireless phones (http://www.fda.gov/cellphones)
Federal Communications Commission (FCC) RF Safety Program
(http://www.fcc.gov/oet/rfsafety)
International Commission on Non-Ionizing Radiation Protection
(http://www.icnirp.de)
World Health Organization (WHO) International EMF Project
(http://www.who.int/emf )
Health Protection Agency (UK) (http://www.hpa.org.uk/radiation/)
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6.5 AVOID POTENTIAL HEARING LOSS
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Prolonged exposure to loud sounds (including music) is the most common cause of
preventable hearing loss. Some scientific research suggests that using portable audio
devices, such as portable music players and cellular telephones, at high volume settings
for long durations may lead to permanent noise-induced hearing loss. This includes the
use of headphones (including headsets, earbuds and Bluetooth® or other wireless
devices). Exposure to very loud sound has also been associated in some studies with
tinnitus (a ringing in the ear), hypersensitivity to sound and distorted hearing. Individual
susceptibility to noise-induced hearing loss and other potential hearing problems varies.
The amount of sound produced by a portable audio device varies depending on the
nature of the sound, the device, the device settings and the headphones. You should
follow some commonsense recommendations when using any portable audio device: