The system JeanA uses, NeurOptimal is a non-volitional system that uses visual and audio stimuli to try to retrain the brain. I spent quite a bit of time analyzing the research and am not particularly impressed.

The before and after comparison is based on self-reporting with no obvious effort to measure or adjust for placebo effect.

It appears to have some similarities to ROSHI but with more real time computer control.

It has no comparison to LENS, a non-volitional NeuroTherapy system that uses minute electromagnetic energy to stimulate the brain.

It also has no comparison to the volitional neurofeedback systems that require the subject to make positive efforts to effect real time change in EEG wave forms.

It looks to be the least intrusive of the non-volitional neurotherapy systems.

I did not research FDA comments but suspect it could be categorized as exempt under a 'relaxation device.'

If I find any other useful information, I will update my post.