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.
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/)
7.6 AVOID POTENTIAL HEARING LOSS
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:
Set the volume in a quiet environment and select the lowest volume at which
you can hear adequately.
When using headphones, turn the volume down if you cannot hear the people
speaking near you or if the person sitting next to you can hear what you are
listening to.
Do not turn the volume up to block out noisy surroundings. If you choose to
listen to your portable device in a noisy environment, use noise‐cancelling
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