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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 manufac-

turers 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)

•

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:

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Chapter 7 − Safety and Warranty

SafetySafety

•

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 rock

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:

American Academy of Audiology

11730 Plaza American Drive, Suite 300

Reston, VA 20190

Voice: 800-AAA-2336, 703-790-8466

Email: info@audiology.org

Internet: 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: nidcdinfo@nidcd.nih.gov

Internet: http://www.nidcd.nih.gov/health/hearing

National Institute for Occupational Safety and Health

Hubert H. Humphrey Bldg.

200 Independence Ave., SW

Washington, DC 20201

Voice: 1-800-CDC-INFO (1-800-232-4636)

Internet: http://www.cdc.gov/niosh/topics/noise/default.html

Safety and Warranty − Chapter 7

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