by Dr. Ryan Neely, PhD
Elemind was created with the mission to improve health with science-backed technology. Core to our foundation is to realize these benefits without causing harmful or unwanted side-effects - and being transparent to our users and the scientific community about our approach and why it works. The Elemind headband is built around many of the same high-quality components that you can find in your favorite devices; however, we believe that industry dogma is not always sufficient to assure safety. We know our users think critically about the products they use, and some may have questions about the wireless capabilities of our system. We have done a critical analysis of our headband, which cleared our high bar for safety. Below, we outline how we think about the electromagnetic fields (EMF) used in wireless technology, and how our device communicates safely over the air.
Electromagnetic (EM) radiation is a phenomenon that can arise from naturally-occurring sources (such as the sun or cosmic rays), but is increasingly present due to the proliferation of man-made sources, including electronically powered devices. We are constantly surrounded by electromagnetic field radiation - some of these sources are harmless, such as the radio waves that are picked up by your car stereo, but others can be concerning in high enough concentrations, such as the energy emitted by an X-Ray machine or UV rays from the sun. Electrical fields are created when there is a difference in charged particles across some distance. An unconnected AA battery has an electric field established by the difference in charge across the positive and negative ends. Magnetic fields, on the other hand, are created whenever there is a flow of electrical current. These fields often arise together and interact, giving rise to fluctuating electromagnetic (EM) fields. These EM fields can fluctuate at different frequencies depending on the source of electrical current driving them. For example, power in the United States is sent over lines as a 60-cycle per second alternating current; in Europe, it fluctuates at 50-cycles per second. Communications equipment can send information over these alternating electromagnetic fields, which is why in Boston, NPR is on 90.9 WBUR (90.9 megahertz or 90.9 million cycles per second) and Kiss 108 is on 107.9 megahertz (MHz) on the radio dial.
When discussing the safety of any source of radiation, scientists and engineers typically refer to ionizing and non-ionizing forms of radiation. Ionizing radiation carries enough energy to ionize atoms and break chemical bonds, while non-ionizing radiation does not. This distinction is important because ionizing radiation can damage cells and DNA, leading to negative health effects. The dividing line between these two types of radiation is a bit blurry, as it depends on the exposure and types of materials involved. Cells have repair mechanisms to handle some exposure to ionizing radiation (such as UV light or an occasional X-ray), but extended exposure can lead to negative health effects.
The wireless radio used by Elemind’s device operates in the 2.4 GHz band - well within the non-ionizing spectrum - meaning it does not carry enough power to ionize atoms. While exposure to low levels of non-ionizing electromagnetic radiation is generally harmless, this is not to say that it isn’t possible for this type of energy to affect the human body. For this reason, some people still have concerns about how much EM radiation they are exposed to, regardless of where it lies on the ionizing or non-ionizing spectrum. The important question is of magnitude: how much EM radiation exposure is safe, and when do EM levels begin to cause concern? A useful framework for this discussion begins with how exposure to EM radiation is measured.
Specific Absorption Rate (SAR)
Electromagnetic radiation is energy that is measured in units of watts. The Specific Absorption Rate, or SAR, measures how much EM radiation is absorbed by a mass of biological tissue in units of watts per kilogram. You might think the SAR of a device would come from a well-established equation, but in reality the SAR is measured by operating the device in question at maximum power next to a manikin of a human torso made of what’s called a “tissue-equivalent liquid,” a medium that approximates the conductive properties of the human body. The amount of EM energy is measured at various locations within the manikin, and the largest SAR value is reported.
In the United States, the FCC sets guidelines for the maximum allowable SAR for a range of different devices. The safe limit for cell phones and similar wireless devices is an SAR of 1.6 watts/kg, averaged over 1 gram of tissue. For reference, the SAR levels of some popular consumer devices are shown below.
|
Device |
Emitter |
Reported SAR (1.6 W/kg safety limit) |
|
Apple AirPods Pro |
Bluetooth |
0.071 to 0.095 W/kg |
|
Samsung Galaxy S23 Ultra |
Bluetooth, WiFi, 5G |
0.98 W/kg (when held at the head) |
|
Microsoft Surface Pro Tablet |
Bluetooth, Wifi |
0.79 W/kg |
|
iPhone 15 |
Bluetooth, WiFi, 5G |
1.49 W/kg |
What wireless hardware is in the Elemind headband?
The circuitry in the Elemind headband uses Bluetooth to shuttle data back and forth to your phone. Bluetooth is a wireless information transfer protocol that operates at a frequency of 2.4 GHz (that's 2.4 billion cycles per second). To be more precise, we use a version of Bluetooth called BLE, which stands for Bluetooth Low Energy. The main difference between standard Bluetooth and BLE is that it’s only active when it needs to send or receive data. As a result it uses far less power, which is advantageous for our engineers, because it means longer battery life. For you, as the end user, it means our headband is rarely working at maximum power. The Bluetooth chip we use meets the FCC compliance standards a SAR of 1.6 watts/kg. In fact, the BLE module used by Elemind is not capable of exceeding this limit even when operated at max power.
EM radiation, cancer, and other health effects
Since cell phones hit the consumer market in the ‘90’s, the question of whether there’s a link between cell phone use and cancer is one that is still debated to this day. A key point in this discussion is the difference between a “biological effect” and a “health effect.”
A biological effect is simply anything that acts on biological tissue. A biological effect could be the change in temperature of the skin, or the feeling of energy after the consumption of caffeine. A “health effect” is one that is harmful to the human body. If an energy source changes the temperature of the skin enough, it can cause a burn. Non-ionizing energy sources are still capable of damaging biological tissue in a similar way, through their ability to generate heat. Your microwave turns this effect into a feature: your food is heated up by the water molecules excited into a higher energetic state by the microwave radiation. Obviously, this would be harmful if it was your body and not your food that was exposed. MRIs and similar scanning technologies are mindful of how much exposure you receive.
As of today, the World Health Organization’s position on EM radiation exposure and cancer (or any other form of adverse health consequences) is that although there are a minority of studies showing a correlation between exposure and cancer, the vast majority of studies find no causal link between low level EM field exposure and adverse health outcomes. This is based on over 25,000 articles published in the past 30 years. Even so, we recognize that many people still desire to limit their exposure to electromagnetic fields. For this reason, we have built our product with a low energy version of Bluetooth radio that operates well within the non-ionizing range of the EM spectrum, ensuring that EM energy levels are below many common devices and far below what the FCC considers safe. To accommodate users who wish to minimize EM exposure even further, we’ve also built Elemind Sleep so that it can be operated without the presence of a cell phone and active Bluetooth link - simply tap the Action button twice, and your session will begin automatically.
Empowering our users with information and choice?
At Elemind, we know our users take a proactive approach in their health, and value innovative solutions that go beyond traditional approaches to health and wellness. Our scientific team works hard to stay up-to-date on new approaches to neuromodulation, but also the latest research on safety as it applies to the kinds of technology we’re building. The engineers at Elemind have created a product that exceeds the safety guidelines of the FCC, and we are committed to remaining transparent about the amount and kind of wireless technology used by our products, as well as giving users options to use them in ways that make them most comfortable.. By giving our users all the information they need to make informed choices as well as building flexible capabilities into our products, we hope to empower our users to create their best health outcomes in a way that keeps them entirely in control.
Additional information
The Federal Communications Commission (FCC) webpage: RF Safety FQ
WHO webpage on Radiation: Electromagnetic Fields
https://www.who.int/news-room/questions-and-answers/item/radiation-electromagnetic-fields#:~:text=Despite%20extensive%20research%2C%20to%20date,at%20power%20line%20and%20radiofrequencies