Yes. In 2018, after years of submitting information to the FDA, NeurOptimal® received the General Wellness Device designation they wanted for their device, as a safe product to be used directly by consumers.  This designation, as contrasted to a Medical Device, which requires oversight by a medical health professional, meant that the FDA concluded the systems was safe to use by consumers directly. Read the FDA Guideline statements from NeurOptimal® here.

The NeurOptimal® system was designed so that the individual's self-assessment is the main tool for tracking changes, rather than data generated by the system itself.

This approach facilitates change in two ways.  One, is that it cultivates the individuals ability to be aware of changes as they occur.  (For children, parents and teachers are encouraged to fill out tracking tools.)  The second, is that the broad changes happen when the brain optimizes its overall performance get captured, rather than just the specific changes the individual was focused on.

Having a self-reporting tool that is filled out every 8-10 sessions helps clients build awareness of the changes that are happening as they train.  Over ten years we refined our Checklist of Concerns to capture the information most helpful for tracking a broad range of areas including cognitive, emotional, and behavioral indicators.   This checklist asks clients to rate their concerns from 1-10 (10 being the worst) and helps us track quantitative changes. For example, when clients see their rate of 10 for "Feelings of Worry, Fear or Anguish"  turn into a 4, they know something is shifting in their mood. 

Using a self-reporting tool also helps to stay disciplined with continuing sessions.  When they see the shifts in numbers, alongside noticing feeling differently they will keep their home training going.

Related Video:

How Many Neurofeedback Sessions Do I Need?

With NeurOptimal® the brain is simply interacting adaptively with itself moment by moment, not striving to produce "more" of some frequency and "less" of another according to an outside “expert”. While those kinds of changes may be observed, they occur as part of an intrinsic self-organizing principal rather than an artificially imposed constraint. This is a large part of both the inherent power and safety of NeurOptimal and how it invites very seamless change.

Related Video:

Is all Neurofeedback Technology the Same? The Evolution of Neurofeedback. Watch on YouTube

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