155FDA has tested hearing aids for interference fromhandheld wireless phones and helped develop avoluntary standard sponsored by the Institute ofElectrical and Electronic Engineers (IEEE). This standardspecifies test methods and performance requirements forhearing aids and wireless phones so that that nointerference occurs when a person uses a compatiblephone 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 forpossible interactions with other medical devices. Shouldharmful interference be found to occur, FDA will conducttesting to assess the interference and work to resolvethe problem.10. What are the results of the research done already?The research done thus far has produced conflictingresults, and many studies have suffered from flaws intheir research methods. Animal experimentsinvestigating the effects of radiofrequency energy (RF)exposures characteristic of wireless phones have yieldedconflicting results that often cannot be repeated in otherlaboratories. A few animal studies, however, havesuggested that low levels of RF could accelerate thedevelopment of cancer in laboratory animals. However,many of the studies that showed increased tumordevelopment used animals that had been geneticallyengineered or treated with cancer-causing chemicals soas to be pre-disposed to develop cancer in the absenceof RF exposure. Other studies exposed the animals to RFfor up to 22 hours per day. These conditions are notsimilar to the conditions under which people usewireless phones, so we don t know with certainty what154Since there are no known risks from exposure to RFemissions from wireless phones, there is no reason tobelieve that accessories that claim to shield the headfrom those emissions reduce risks. Some products thatclaim to shield the user from RF absorption use specialphone cases, while others involve nothing more than ametallic accessory attached to the phone. Studies haveshown that these products generally do not work asadvertised. Unlike “hand-free” kits, these so-called“shields” may interfere with proper operation of thephone. The phone may be forced to boost its power tocompensate, leading to an increase in RF absorption. InFebruary 2002, the Federal trade Commission (FTC)charged two companies that sold devices that claimed toprotect wireless phone users from radiation with makingfalse and unsubstantiated claims. According to FTC,these defendants lacked a reasonable basis tosubstantiate their claim.9. What about wireless phone interference with medicalequipment?Radiofrequency energy (RF) from wireless phones caninteract with some electronic devices. For this reason,FDA helped develop a detailed test method to measureelectromagnetic interference (EMI) of implanted cardiacpacemakers and defibrillators from wireless telephones.This test method is now part of a standard sponsored bythe Association for the Advancement of Medicalinstrumentation (AAMI). The final draft, a joint effort byFDA, medical device manufacturers, and many othergroups, was completed in late 2000. This standard willallow manufacturers to ensure that cardiac pacemakersand defibrillators are safe from wireless phone EMI.AAppppeennddiixx AAppppeennddiixx