Disclaimer

Mind Gear products are designed for recreational purposes and personal exploration only. No medical claims are made for Mind Gear products, expressly or implied. They are not medical devices and should not be used for the relief of any medical condition. Please consult with your licensed medical practitioner prior to use for any other purpose as the machine is not intended as a replacement for medical or psychological treatment. Our products are not intended to affect the structure or any function of the human body. These products are not approved for any purpose by the FDA.

The reason that these devices are not FDA approved is that the FDA operates on the following principles:

   * Anything that alters body or brain function is a medical treatment

   * Medical treatments can and should only be used to cure disease

Because our product is designed for recreational use, the FDA will not consider approving the product. Although our product is not FDA approved, that does not imply that AVS devices are illegal. Section 510 of the Pure Food & Drug Act, the law that created the FDA, specifically says that the organization cannot place a ban on any device that was in use prior to 1976. AVS was in use long before that, see the AVS Info page, so it falls under this law.

Medical Info

Photosensitivity

Audio Visual Stimulation (AVS) devices have been in use for years. Thousands of users have experienced many hours on them with almost no ill effects. The one exception to this is individuals who are photosensitive. Those with photosensitivity respond negatively to flickering light. Photosensitivity can cause individuals to seize when they are exposed to certain situations. The light can come from any number of sources ranging from television screens to passing police cars.

Our device uses flashing lights with the capacity to be very intense. This stimulation may trigger a dormant case of photosensitivity. Because of this users should always take caution with their first use. The risk of dormant photosensitivity is very small for most people, and the small risk of having it should not dissuade anyone from using the AVS system.

Neurologists say that it is better for photosensitivity to be recognized when using a mental system in a safe environment because then the condition can be addressed and symptoms controlled. Symptoms of photosensitivity can arise in a less controlled environment such as while driving a car or in a public place and cause far more danger to the individual.

Most persons with photosensitive epilepsy have an emergence of symptoms during their teenage years (75% by age 20). The likelihood of a child having Photosensitivity is 1 in 4000. About half of initial emergences are induced by watching television. Some persons who are susceptible during their teenage years outgrow the condition, about 25% by age 25. Adults over age 25 who have never had a display of symptoms have about a 1 in 20,000 chance of having dormant photosensitivity. A good rule of thumb is that if an individual can stand in front of a strobe light without discomfort, they will not have a problem with AVS.

The light stimulation part of the AVS system combined with the sound leads to better brain perfusion and entrainment and thus should be used if possible. That being said, the system still operates as intended without the visual stimulus.

Epilepsy Sources

Harding, Graham et al. (1994). Photosensitive Epilepsy. Mac Keith Press, London.

http://www.epilepsymatters.com/english/faqphotosensitive.html

http://www.epilepsyfoundation.org/aboutepilepsy/