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FDA CONSUMER UPDATE
1. Do wireless phones pose a health hazard?
The available scientific evidence does not show that any health problems are
associated with using wireless phones. There is no proof, however, that wireless
phones are absolutely safe. Wireless phones emit low levels of radiofrequency
energy (RF) in the microwave range while being used. They also emit very low
levels of RF when in the stand-by mode. Whereas high levels of RF can produce
health effects (by heating tissue), exposure to low level RF that does not produce
heating ef-fects causes no known adverse health effects. Many studies of low level
RF exposures have not found any biological ef-fects. Some studies have
suggested that some biological ef-fects may occur, but such findings have not
been confirmed by additional research. In some cases, other researchers have had
difficulty in reproducing those studies, or in determining the reasons for
inconsistent results.
2. What is FDA’s role concerning the safety of wireless phones?
Under the law, FDA does not review the safety of radiation-emitting consumer
products such as wireless phones before they can be sold, as it does with new
drugs or medical de-vices. However, the agency has authority to take action if
wire-less phones are shown to emit radiofrequency energy (RF) at a level that is
hazardous to the user. In such a case, FDA could require the manufacturers of
wireless phones to notify users of the health hazard and to repair, replace or recall
the phones so that the hazard no longer exists. Although the existing scientific data
do not justify FDA regula-tory actions, FDA has urged the wireless phone industry
to take a number of steps, including the following:
• Support needed research into possible biological effects of RF of the type
emitted by wireless phones;
• Design wireless phones in a way that minimizes any RF ex-posure to the user
that is not necessary for device function;
and
• Cooperate in providing users of wireless phones with the best possible
information on possible effects of wireless phone use on human health.
FDA belongs to an interagency working group of the federal agencies that have
responsibility for different aspects of RF safety to ensure coordinated efforts at the
federal level. The following agencies belong to this working group:
• National Institute for Occupational Safety and Health
• Environmental Protection Agency
• Federal Communications Commission
• Occupational Safety and Health Administration
• National Telecommunications and Information Administration
The National Institutes of Health participates in some inter-agency working group
activities, as well. FDA shares regulatory responsibilities for wireless phones with
the Federal Communications Commission (FCC). All phones that are sold in the
United States must comply with FCC safety guidelines that limit RF exposure. FCC
relies on FDA and other health agencies for safety questions about wireless
phones. FCC also regulates the base stations that the wireless phone networks
rely upon. While these base stations operate at higher power than do the wireless
phones themselves, the RF expo-sures that people get from these base stations
are typically thousands of times lower than those they can get from wire-less
phones. Base stations are thus not the subject of the safety questions discussed in
this document.
3. What kinds of phones are the subject of this update?
The term “wireless phone” refers here to hand-held wireless phones with built-in
antennas, often called “cell,” “mobile,” or “PCS” phones.
U.S. Food and Drug Administration -Center for Devices and
Radiological Health Consumer Update on Wireless Phones
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HEARING AID COMPATIBILITY WITH
MOBILE PHONES
FCC Hearing-Aid Compatibility (HAC) Regulations for Wireless Devices
On July 10, 2003, the U.S. Federal Communications Commission (FCC) Report and
Order in WT Docket 01-309 modified the exception of wireless phones under the
Hearing Aid Compatibility Act of 1988 (HAC Act) to require digital wireless phones
be compatible with hearing-aids. The intent of the HAC Act is to ensure reasonable
access to telecommunications services for persons with hearing disabilities.
While some wireless phones are used near some hearing devices (hearing aids and
cochlear implants), users may detect a buzzing, humming, or whining noise. Some
hearing devices are more immune than others to this interference noise, and
phones also vary in the amount of interference they generate.
The wireless telephone industry has developed a rating system for wireless phones,
to assist hearing device users find phones that may be compatible with their
hearing devices. Not all phones have been rated. Phones that are rated have the
rating on their box or a label located on the box.
The ratings are not guarantees. Results will vary depending on the user’s hearing
device and hearing loss. If your hearing device happens to be vulnerable to
interference, you may not be able to use a rated phone successfully. Trying out the
phone with your hearing device is the best way to evaluate it for your personal
needs.
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M-Ratings:
Phones rated M3 or M4 meet FCC requirements and are likely to
generate less interference to hearing devices than phones that are not
labeled. M4 is the better/higher of the two ratings.
Hearing devices may also be rated. Your hearing device manufacturer or hearing
health professional may help you find this rating. Higher ratings mean that the
hearing device is relatively immune to interference noise. The hearing aid and
wireless phone rating values are then added together. A sum of 5 is considered
acceptable for normal use. A sum of 6 is considered for best use.
In the right example, if a hearing aid meets the M2 level
rating and the wireless phone meets the M3 level rating,
the sum of the two values equal M5. This should provide
the hearing aid user with “normal usage” while using their
hearing aid with the particular wireless phone. “Normal
usage” in this context is defined as a signal quality that is
acceptable for normal operation.
The M mark is intended to be synonymous with the U mark. The T mark is intended
to be synonymous with the UT mark. The M and T marks are recommended by the
Alliance for Telecommunications Industries Solutions (ATIS). The U and UT marks
are referenced in Section 20.19 of the FCC Rules. The HAC rating and
measurement procedure are described in the American National Standards Institute
(ANSI) C63.19 standard.
For information about hearing aids and digital wireless phone
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Fcc Hearing Aid Compatibility and Volume Control
http://www.fcc.gov/cgb/dro/hearing.html
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Gallaudet University, RERC
http://tap.gallaudet.edu/DigWireless.KS/DigWireless.htm
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Self Help for Hard of Hearing People Inc. [SHHH]
www.hearingloss.org/hat/TipsWirelessPhones.htm
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The Hearing Aid Compatibility FCC Order
http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-03-168A1.pdf
