About HEG and FDA requirements for neurofeedback brain training equipment.
The Peanut is very nice technology, but most important is that it allows some changes in software which are played out in HEG Studio. It’s still in its first releases, but it’s already very cool, and it means that people can choose to do just HEG with a Peanut and never have to buy BioExplorer. Those who have BioExplorer can use the Peanut with it as well.
All nIR HEG training, whether using a Peanut, Pendant or Q-WIZ. uses the same headband.
If you are using a Pendant nIR HEG, then you’ll need to install the wireless dongle so Windows assigns it a COM port. Once that’s done, you plug the headband into the Pendant (or whatever amplifier you are using) and open a design for HEG training, turn everything on and get connected, then go.
FDA Requirements for Equipment
The FDA does not require any neurofeedback equipment to be listed or certified. It does not require that trainers be “certified” by anyone either. There is an option for manufacturers who wish to apply voluntarily for a 510k. This means they spent the money to hire an attorney, fill out a bunch of paperwork, paid fees to the FDA and got a document stating that their equipment appears to be the same as other equipment that has been inspected.
There is no certification required in the US, in Canada, in any European countries of which I’m aware, in Australia. I don’t know about Asia, but certainly any place that chooses to require them is not basing their decision on FDA guidelines.
Obviously if you are charging $3,000-4,000 for an amplifier (when the Q-WIZ and Optima 4 are below $1,000 to do the same work with the same quality), you can afford to pay to be certified, and then you can convince people who don’t really understand the FDA’s regulations that they need to purchase FDA “certified” units. The Pendant and the Focus and the Optima and all the other units we sell (including electrodes and HEG headbands and software, etc.) do not require FDA certification. Neither do the BrainMasters, Infinitis, Nexus, etc. that have paid to get it. Professional trainers or lay trainers can use any of them to do good training. Just that they won’t be allowed to purchase the expensive units–also not because of the FDA, but because it’s a nice marketing approach.
“Medical grade” equipment sounds pretty impressive. It’s a nice marketing technique to make it sound different from other options. When they say “medical grade”, they simply mean that they have gone through the steps and spent the money to have their equipment registered (not tested or certified) by the FDA.in a process known as 510(k). According to the FDA’s own website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3019 ), biofeedback devices are exempt from 510(k) requirements. Certainly any company that wishes can apply to have their device certified. The nice part of getting the FDA to register your device–and then calling it “medical grade”–is that it makes things tougher for foreign competitors. There are excellent alternatives from Argentina, Australia and the Netherlands which have a harder time “proving” what the FDA calls “good manufacturing practices”, even though their manufacturing practices are as good or better than BrainMaster’s, because they are overseas. In terms of specs, in terms of safety requirements, in terms of the quality of the equipment itself–and in terms of the number of NF providers who prefer those devices–they are in every way equal or better.
The FDA recognizes “biofeedback” (no specific category for neurofeedback) for five purposes:
1. General relaxation
2. Relaxation for Stress Management
3. Muscle relaxation
4. Muscle relaxation for pain management, and
5. Quality of life management.
It exempts biofeedback devices because it doesn’t consider them very dangerous or invasive. Apparently there have not been many (or any) complaints about misuse or damage to clients–which is also the case with the much more invasive light/sound devices. To the best of my knowledge the FDA doesn’t say who can buy them or who can use them. The FDA has almost certainly never heard of BCIA.