133 134
11. What about wireless phone interference with medical equipment?
Radiofrequency energy (RF) from wireless phones can interact with some electronic 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.
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/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
HomeBusinessandEntertainment/CellPhones/default.htm)
• 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/peh-emf/en/)
• National Radiological Protection Board (UK) (http://www.hpa.org.uk/radiation/)
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 headphones to block out background environmental noise.
• Limit the amount of time you listen. As the volume increases, less time is required before your hearing could be affected.
• Avoid using headphones after exposure to extremely loud noises, such as concerts, that might cause temporary hearing loss. Temporary
hearing loss might cause unsafe volumes to sound normal.
• Do not listen at any volume that causes you discomfort. If you experience ringing in your ears, hear muffled speech or experience any
temporary hearing difficulty after listening to your portable audio device, discontinue use and consult your doctor.
YOU CAN OBTAIN ADDITIONAL INFORMATION ON THIS SUBJECT FROM THE
FOLLOWING SOURCES:
AMERICA ACADEMY OF AUDIOLOGY
11730 Plaza American Drive, Suite 300
Reston, VA 20190
Voice: 800-AAA-2336
Email: infoaud@audiology.org
Internet: http://www.audiology.org
NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION
DISORDERS
NATIONAL INSTITUTES OF HEALTH:
31 Center Drive, MSC 2320
Bethesda, MD USA 20892-2320
Voice: (301) 496-7243
Email: wengerj@nidcd.nih.gov
Internet: http://www.nidcd.nih.gov/health/hearing
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 Clifton Rd. Atlanta, GA 30333, USA
Voice: 800-CDC-INFO (800-232-4636)
Internet: http://www.cdc.gov/niosh/topics/noise/default.html
FCC COMPLIANCE INFORMATION
This device complies with Part 15 of FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received. Including interference that may cause undesired operation.
INFORMATION TO THE USER
This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful Interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful Interference to radio communications. However, there is no guarantee that interference will not occur in a particular Installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet of a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for assistance.
CAUTION: Changes or modification not expressly approved by the party responsible for compliance could void the user’s authority to
operate the equipment. Connecting of peripherals requires the use of grounded shielded signal cables.
