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The following news blog offers interesting insight into the birth of a new treatment option. LENS neurotherapy is different from classic EEG neurofeedback in that there is no active participation from the patient. The system feeds back the brain's own pattern (with a very slight offset) at extremely low power and for a very short time.
A Report from the ISNR Meeting on the LENS AttackEEG Info said:The Board’s concern is whether any kind of brain stimulation constitutes the practice of medicine. The Board made this conclusion without any specific information or public hearing, and without Mary Lee being able to offer any evidence to the contrary. However, Rick and Mary Lee are going to be fighting this determination. In fact that will be the central issue in an administrative law case, if it comes to that. This charge about stimulation was met with a lot of dissent stating that the LENS/FLEXYX’s radiated power is so miniscule as to be almost undetectable, and certainly far less than that involved in a device such as the Alpha Stim. To this point Jaffe responded that the FDA cares only about the intended use. They don’t care about regular frequency-based neurofeedback devices or peripheral neurofeedback devices, all of which involve the display of biological information for the volitional control by the client- so most of us are safe with these. The FDA does not care what the individual providers do as they only regulate devices and drugs and the manufacturers that build them and sell them.