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Answer to Question #8460 Submitted to "Ask the Experts"Category: Consumer Products The following question was answered by an expert in the appropriate field: Q
I am a diagnostic medical physicist and had someone ask me if hearing aids could be affected by radiation. She was told by her physician, and apparently in the instructions of the device, that the units could be adversely affected by exposure to radiation. I have never come across such information. Is there data or information that could lead to such a claim? The hearing aids were apparently a special, custom-made type of device. I did not see the instructions personally; these were questions from the user of the aids. Any information would be much appreciated. A
If there is a safety issue, the hearing aid manufacturer must identify it in its label. Most medical device manufacturers are aware of potential interference from radio frequency waves, magnetic fields, or even ionizing radiation. Similar to ALARA, the policy of exposing individuals to radiation that is "as low as reasonably achievable," most manufacturers want to be prudent and simply may warn against "possible" interference, even if such information is lacking. For example, many medical product manufacturers may make a statement about using their products on pregnant women, yet pregnant women may never have been tested with their product. So the statement is not necessarily based on scientific data, but the lack of such data. I also suspect that product liability may sometimes be the driving force behind such statements, but I am not sure. Let me relate a true experience. A few years ago some of the security screening devices that detect package theft from department stores were causing interference with some implanted medical devices. These were rare and unpredictable, but in fact were occurring. The position of some security screening manufacturers was that it was the device manufacturer's responsibility. The medical device manufacturers countered with the fact that these screening systems were hidden and patients would not necessarily know when they were near such a detector. Since the Food and Drug Administration (FDA) also has the authority to regulate any electronic product, it used its authority to simply discuss the topic at an advisory committee in the public forum. The security screening companies' lack of experience with FDA resulted in an unexpected but serious increase in their anxiety level. They believed, incorrectly, that FDA could ban their product. The public meeting was enlightening. And finally, I refer you to our own Health Physics Society site.
Answer posted on 15 September 2009. The information and material posted on this Web site is intended as general reference information only. Specific facts and circumstances may alter the concepts and applications of materials and information described herein. The information provided is not a substitute for professional advice and should not be relied upon in the absence of such professional advice specific to whatever facts and circumstances are presented in any given situation. Answers are correct at the time they are posted on the Web site. Be advised that over time, some requirements could change, new data could be made available, or Internet links could change. For answers that have been posted for several months or longer, please check the current status of the posted information prior to using the responses for specific applications.
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