The first NeuroSonics technology, Brain Generated Music (BGM), is a brain wave biofeedback system capable of evoking the "Relaxation Response," a desirable state of deep relaxation.
Other forms of biofeedback require conscious mental effort and the user needs to learn appropriate techniques to translate the feedback into the desired response. The NeuroSonics BGM technology does not require training or conscious effort. The evocation of increased alpha wave production and diminished beta wave activity is automatic and based on a psychoacoustic response to the BGM sounds that is not dependent on conscious direction.
The technology has shown promising results in a pilot stress reduction study at The Johns Hopkins Hospital. Subjects reported experiencing a profound state of relaxation within ten minutes of using the BGM system. While the study should be regarded as preliminary, the results were very positive and strongly suggestive of a reliable effect in evoking the relaxation response.
BGM appears to be non habit-forming, free of side effects, and excellently suited for long-term self-regulatory and behavioral medicine. This leads us to speculate that we may have the basis of a new, scientifically valid, natural "psycho-pharmaceutical" or "drugless drug."
The Food and Drug Administration (FDA) regulates the sale of any products for which medical claims are made. NeuroSonics does not believe that FDA approval is required with respect to distribution and sale of products because they utilize the MCC technology or the BGM technology to evoke the relaxation response.
The FDA places therapeutic products into several classes. BGM, along with other biofeedback devices, falls into "Class 2" which means that the FDA must be notified before marketing of BGM products begins, but that those products do not have to pass a pre-marketing review by the FDA. There is little likelihood that this regulatory position will change in the future. Certain additional medical claims that the company may wish to make regarding future generations of the companys products may require FDA approval.