Re: 2.5 SW

[Guest guest]

Zelda, what new FDA regs?

2.5 SW

Haven't posted anything in ages but I just got the 2.5 BMer SW andthough the manual is still absolutely dreadful and poorly organized, Idid get it pretty well configured yesterday and it is a bit moreuser-friendly than it's 1.9 predecessor. Lots more animations and abit of streamlining as far as setting up folders, procedures for usingit, etc.I had gotten so frustrated with the old SW that I just took avacation from it for a while; couldn't face it. So I am very excitedto be up and running again and in the 21st century. Just wonder whatwill happen next time I have to upgrade, what with new FDA regs.

[Guest guest]

, I am not a clinician. This time buying the BMer, I had to have my clinician sign off for me, here I didn't when I bought the first one. It is fair and appropriate for there to be more supervision, but it is a burden for her, I think. She doesn't even use BMer anymore so I will have to use protocols estab on another system which she uses.Zelda" St. Clair, MSW" <mastclair@...> wrote: Zelda, what new FDA regs?

2.5 SW Haven't posted anything in ages but I just got the 2.5 BMer SW andthough the manual is still absolutely dreadful and poorly organized, Idid get it pretty well configured yesterday and it is a bit moreuser-friendly than it's 1.9 predecessor. Lots more animations and abit of streamlining as far as setting up folders, procedures for usingit, etc.I had

gotten so frustrated with the old SW that I just took avacation from it for a while; couldn't face it. So I am very excitedto be up and running again and in the 21st century. Just wonder whatwill happen next time I have to upgrade, what with new FDA regs.

[Guest guest]

Zelda,

The 2.5 software is a huge jump even from 2.0--much less from the previous

versions. You haven't even begun to scratch the surface of some of the changes.

The games are nice, but the ability to design more sophisticated training

challenges and feedback is a great advancement.

It's intriguing to me that the same thing that seems to work in politics--what

Orwell called the " Big Lie " (e.g. war is peace)--is working as well in

scientific fields. I've certainly heard all the desperate noise and threats

about the FDA, and I must admit that from time to time, being someone who breaks

all the rules, since I actually allow non-professionals to participate in my

workshops and I sell equipment to anyone who thinks they can benefit from it,

I've felt a bit anxious about it myself.

I just spent an evening with the head of a biofeedback equipment manufacturing

company that makes some very well-known equipment. He shook his head when the

subject of the FDA came up. " I don't understand all the fuss, " he told me. " We

looked into getting FDA approval, but we were told that neurofeedback equipment

is in the " exempt " category. " They were told they could apply, if they chose,

but it wasn't necessary.

That certainly doesn't sound like all the threatening rhetoric I've been

hearing, but here's what's written, with quotes from the FDA regs themselves, in

the AAPB document on the subject:

" 'Unless exempted from premarket notification requirements, persons may not

market a new device, under section 510(K), unless they receive a substantial

equivalence order from the FDA or an order reclassifying the device into Class I

or Class II (section 513(I) of the Act).'

There is now one exception, and that is for the selling of battery operated

biofeedback equipment. "

So any company that applies for a 510(K) for its battery-operated biofeedback

equipment is doing it for...well, you can decide for yourself what the reasons

might be. And please note that what is required is simply to show that the

device is " substantially equivalent " to some other device already submitted. So

a Brainmaster can be submitted as pretty much the same as a procomp, etc. In

other words, this is not some big FDA safety or quality control check. It's a

profroma activity that allows some manufacturers to claim that their devices are

more " ethical " or higher-quality or whatever and be believed by those of us who

haven't actually slogged through the FDA regs.

Software, like BioExplorer, which some of you may have heard is not up to snuff

because it hasn't gone through FDA processes CAN'T go through the processes,

even if the company wanted to. Why? There aren't any. Software like

Brainmaster, which is attached to hardware, could presumably be piggy-backed

onto the hardware, but since the FDA is interested in " devices " , there really

aren't any freestanding requirements for software.

Now comes the great part. We all know that, if the FDA did regulate biofeedback

equipment, it would only be acceptable for relaxation--certainly not improvement

of attention or mood or anything like that. But did you know that it is

specifically forbidden to state that QEEG equipment is used to diagnose?! In

short, many of those who are loudest in their blusterings are the very ones who

use their equipment for purely off-label uses!

This is a giant hall of mirrors--at least it feels that way to me. We can't do

anything to stop those who choose to take advantage of the confusion to try to

get a leg up in the marketplace or to bully others or to block competition. All

we can do is keep the facts clear in front of us, so we can hold our breath when

someone is blowing smoke in our direction.

As for the " new FDA regs " , I'm not aware of what those might be or even that

there are any. It appears to me that the FDA has its plate pretty full with

drugs it has approved as being safe (based on research funded by the drug

manufacturers) regularly being shown to have serious damaging effects on human

beings after the fact. Those are cases with tens and hundreds of thousands of

impacts, and they are right down the middle of the FDA's regulatory fairway.

The gloom-and-doomers keep worrying about (or perhaps hoping for) some massive

public outcry about seriious damage being done by brain training, which might

force the FDA to look into the field. So far so good.

So relax, Zelda. Enjoy your new software and do good work.

Pete

..

>

> From: " Zelda Bell " <momsneighborhood@...>

> Date: 2006/06/12 Mon PM 10:03:10 EDT

>

> Subject: 2.5 SW

>

> Haven't posted anything in ages but I just got the 2.5 BMer SW and

> though the manual is still absolutely dreadful and poorly organized, I

> did get it pretty well configured yesterday and it is a bit more

> user-friendly than it's 1.9 predecessor. Lots more animations and a

> bit of streamlining as far as setting up folders, procedures for using

> it, etc.

> I had gotten so frustrated with the old SW that I just took a

> vacation from it for a while; couldn't face it. So I am very excited

> to be up and running again and in the 21st century. Just wonder what

> will happen next time I have to upgrade, what with new FDA regs.

[Guest guest]

If you buy from BrainMaster directly, you will have to meet that requirement.

Or you can buy any BrainMaster hardware or software through brain-trainer.com

(as you did your first one), and you won't need any of that. Of course you'll

have to pay 10% LESS to buy from Brain-Trainer, but it may be worth it...

Pete

>

> From: ZELDA BELL <momsneighborhood@...>

> Date: 2006/06/13 Tue AM 10:10:56 EDT

>

> Subject: Re: 2.5 SW

>

> ,

> I am not a clinician. This time buying the BMer, I had to have my clinician

sign off for me, here I didn't when I bought the first one. It is fair and

appropriate for there to be more supervision, but it is a burden for her, I

think. She doesn't even use BMer anymore so I will have to use protocols estab

on another system which she uses.

> Zelda

>

> " St. Clair, MSW " <mastclair@...> wrote:

> Zelda, what new FDA regs?

>

>

> 2.5 SW

>

>

> Haven't posted anything in ages but I just got the 2.5 BMer SW and

> though the manual is still absolutely dreadful and poorly organized, I

> did get it pretty well configured yesterday and it is a bit more

> user-friendly than it's 1.9 predecessor. Lots more animations and a

> bit of streamlining as far as setting up folders, procedures for using

> it, etc.

> I had gotten so frustrated with the old SW that I just took a

> vacation from it for a while; couldn't face it. So I am very excited

> to be up and running again and in the 21st century. Just wonder what

> will happen next time I have to upgrade, what with new FDA regs.

>

>

>

>

>

>

>

>

[Guest guest]

et all, Thanks for the clarification. I am still trying to find someone to do neurofeedback in my county as well. Very frustrating to have to drive 30-40 mins for the occasional appointment and even more frustrating that most therapists still are out in the cold here in my county. I have toyed with the idea of getting certified but it would take so long to get the degrees that it is not realistic for me. I need to get back to a full time job within a year or so. However, I talked to someone the other night who is a teacher in the public schools but sounds like she has a degree in counselling and she has already done biofeedback and was very interested in nf. (I am always the cheerleader for nf and continue to raise the profile of it). And her principal is a very pro-active principal as well. Another school based study? Hmmm... However, it is important to note that it

isn't for everyone. Many people are simply not willing to make any lifestyle changes. I just had this experience with someone from work who tried nf for her son but was not willing or able to limit the video games as it would be much harder for her to get anything done as a working Mom. So, we are dealing with a lot of societal pressures as well. Most parents I know whose kids are younger than 17 or so, do not give video games a second thought as far as their deleterious effects. Very frustrating that many people who could truly benefit from nf just plain could never afford it. Wish someone would come up with a solution for that.Zelda Van Deusen <pvdtlc@...> wrote: Zelda, The 2.5 software is a huge jump even from 2.0--much less from the previous versions. You haven't even begun to scratch the surface of some of the changes. The games are nice, but the ability to design more sophisticated training challenges and feedback is a great advancement. It's intriguing to me that the same thing that seems to work in politics--what Orwell called the "Big Lie" (e.g. war is peace)--is working as well in scientific fields. I've certainly heard all the desperate noise and threats about the FDA, and I must admit that from time to time, being someone who breaks all the rules, since I actually allow non-professionals to participate in my workshops and I sell equipment to anyone who thinks they can benefit from it, I've felt a bit anxious about it myself. I just

spent an evening with the head of a biofeedback equipment manufacturing company that makes some very well-known equipment. He shook his head when the subject of the FDA came up. "I don't understand all the fuss," he told me. "We looked into getting FDA approval, but we were told that neurofeedback equipment is in the "exempt" category." They were told they could apply, if they chose, but it wasn't necessary. That certainly doesn't sound like all the threatening rhetoric I've been hearing, but here's what's written, with quotes from the FDA regs themselves, in the AAPB document on the subject: "'Unless exempted from premarket notification requirements, persons may not market a new device, under section 510(K), unless they receive a substantial equivalence order from the FDA or an order reclassifying the device into Class I or Class II (section 513(I) of the Act).' There is now one exception, and that is for the selling of battery operated

biofeedback equipment. " So any company that applies for a 510(K) for its battery-operated biofeedback equipment is doing it for...well, you can decide for yourself what the reasons might be. And please note that what is required is simply to show that the device is "substantially equivalent" to some other device already submitted. So a Brainmaster can be submitted as pretty much the same as a procomp, etc. In other words, this is not some big FDA safety or quality control check. It's a profroma activity that allows some manufacturers to claim that their devices are more "ethical" or higher-quality or whatever and be believed by those of us who haven't actually slogged through the FDA regs. Software, like BioExplorer, which some of you may have heard is not up to snuff because it hasn't gone through FDA processes CAN'T go through the processes, even if the company wanted to. Why? There aren't any. Software like Brainmaster, which is attached to

hardware, could presumably be piggy-backed onto the hardware, but since the FDA is interested in "devices", there really aren't any freestanding requirements for software. Now comes the great part. We all know that, if the FDA did regulate biofeedback equipment, it would only be acceptable for relaxation--certainly not improvement of attention or mood or anything like that. But did you know that it is specifically forbidden to state that QEEG equipment is used to diagnose?! In short, many of those who are loudest in their blusterings are the very ones who use their equipment for purely off-label uses! This is a giant hall of mirrors--at least it feels that way to me. We can't do anything to stop those who choose to take advantage of the confusion to try to get a leg up in the marketplace or to bully others or to block competition. All we can do is keep the facts clear in front of us, so we can hold our breath when someone is blowing smoke in our

direction. As for the "new FDA regs", I'm not aware of what those might be or even that there are any. It appears to me that the FDA has its plate pretty full with drugs it has approved as being safe (based on research funded by the drug manufacturers) regularly being shown to have serious damaging effects on human beings after the fact. Those are cases with tens and hundreds of thousands of impacts, and they are right down the middle of the FDA's regulatory fairway. The gloom-and-doomers keep worrying about (or perhaps hoping for) some massive public outcry about seriious damage being done by brain training, which might force the FDA to look into the field. So far so good. So relax, Zelda. Enjoy your new software and do good work. Pete . > > From: "Zelda Bell" <momsneighborhoodverizon (DOT) net> > Date: 2006/06/12 Mon PM 10:03:10 EDT > > Subject: 2.5 SW > > Haven't posted anything in ages but I just got the 2.5 BMer SW and > though the manual is still absolutely dreadful and poorly organized, I > did get it pretty well configured yesterday and it is a bit more > user-friendly than it's 1.9 predecessor. Lots more animations and a > bit of streamlining as far as setting up folders, procedures for using > it, etc. > I had gotten so frustrated with the old SW that I just took a > vacation from it for a while; couldn't face it. So I am very excited > to be up and running again and in the 21st century. Just wonder what > will happen next time I have to upgrade, what with new FDA regs.

[Guest guest]

Zelda~

Where are you located? If you ask on the list you may be able to find some who do train at home near you that you can connect with for support and encouragement. Being in the Wash DC/Virginia area where we have a neurofeedback group approaching 100 members, I know most could not have gained as much without the constant support of the group. And ....what's important to note is a good percentage of the group are also licensed therapists from several different practices or agencies who also benefit from the support and the interaction at our meetings. (we don't discriminate :~)

Perhaps this list can help you locate other trainers.

~

2.5 SW> > Haven't posted anything in ages but I just got the 2.5 BMer SW and> though the manual is still absolutely dreadful and poorly organized, I> did get it pretty well configured yesterday and it is a bit more> user-friendly than it's 1.9 predecessor. Lots more animations and a> bit of streamlining as far as setting up folders, procedures for using> it, etc.> I had gotten so frustrated with the old SW that I just took a> vacation from it for a while; couldn't face it. So I am very excited> to be up and running again and in the 21st century. Just wonder what> will happen next time I have to upgrade, what with new FDA regs.

[Guest guest]

, We are in Prince s Co. near College Park, MD.Zelda Duncan <karenduncan@...> wrote: Zelda~ Where are you located? If you ask on the list you may be able to find some who do train at home near you that you can connect with for support and encouragement. Being in the Wash DC/Virginia area where we have a neurofeedback group approaching 100 members, I know most could not have gained as much without the constant support of the

group. And ....what's important to note is a good percentage of the group are also licensed therapists from several different practices or agencies who also benefit from the support and the interaction at our meetings. (we don't discriminate :~) Perhaps this list can help you locate other trainers. ~ 2.5 SW> > Haven't posted anything in ages but I just got the 2.5 BMer SW and> though the manual is still absolutely dreadful and poorly organized, I> did get it pretty well configured yesterday and it is a bit more> user-friendly than it's 1.9 predecessor. Lots more animations and a> bit of streamlining as far as setting up folders, procedures for using> it, etc.> I had gotten so frustrated with the old SW that I just took a> vacation from it for a while; couldn't face it. So I am very excited> to be up and running again and in the 21st century. Just wonder what> will happen next

time I have to upgrade, what with new FDA regs.

[Guest guest]

, You know I started to think about this email and I remembered that when I was beginning to negotiate to buy the BMer that there was a lag in the time my clinician got back to themto sign off and I called them back and said that perhaps I could talk to you, instead. I was told that even you would have problems purchasing it with the new regs. (Because I had thought of going through you, though their price was really fabulous). So now I am a bit ticked off at BMer because now I am somewhat committed to return to my clinician on a more regular, (and costly and inconvenient basis) in order to do the honorable thing and not make her feel in jeopardy. I do have to say though, that when my son started NF five or so years ago, he was so resistant and violent that getting him to sessions in the first couple months were very difficult, and dangerous for me. Once I had to almost take the door

off the hinges as he barricaded himself in the bathroom. And, there were times early on when a training didn't work well and we had to go back unexpectedly as he had turned into Satan. So, if insurance paid for this, I would be fine with more supervision for just such reasons. I just can't see people doing this without knowing what they are doing. I mean, there are several family members I would like to work on but would prefer that they went to someone more knowledgeable first to get some protocols set first, and then I could reinforce it.Zelda Van Deusen <pvdtlc@...> wrote: If you buy from BrainMaster directly, you will have to meet that requirement. Or you can buy any BrainMaster hardware or software through brain-trainer.com (as you did your first one), and you won't need any of that. Of course you'll have to pay 10% LESS to buy from Brain-Trainer, but it may be worth it... Pete > > From: ZELDA BELL <momsneighborhoodverizon (DOT) net> > Date: 2006/06/13 Tue AM 10:10:56 EDT > > Subject: Re: 2.5 SW > > , > I am not a clinician. This time buying the BMer, I had to have my clinician sign off for me, here I didn't when I bought the first one. It is fair and appropriate for there to be more supervision, but it is a burden for her, I think. She doesn't even

use BMer anymore so I will have to use protocols estab on another system which she uses. > Zelda > > " St. Clair, MSW" <mastclairsbcglobal (DOT) net> wrote: > Zelda, what new FDA regs? > > > 2.5 SW > > > Haven't posted anything in ages but I just got the 2.5 BMer SW and > though the manual is still absolutely dreadful and poorly organized, I > did get it pretty well configured yesterday and it is a bit more > user-friendly than it's 1.9 predecessor. Lots more animations and a > bit of

streamlining as far as setting up folders, procedures for using > it, etc. > I had gotten so frustrated with the old SW that I just took a > vacation from it for a while; couldn't face it. So I am very excited > to be up and running again and in the 21st century. Just wonder what > will happen next time I have to upgrade, what with new FDA regs. > > > > > > > >

[Guest guest]

Zelda~

If you take workshops and learn how to interpret the TLC assessments working on your own can be very successful. Like I mentioned in my previous email we are home trainers, working on our own, clinician free, we learned in the same workshops with clinicians.

We are having Pete come for workshops in September (about an hour from you) to Woodbridge. Please consider looking into them, they are such an incredible resource and so are our members as we are working on so many issues with our families, the support is what ties it all together.

Hope to connect with you soon,

~

2.5 SW> > > Haven't posted anything in ages but I just got the 2.5 BMer SW and> though the manual is still absolutely dreadful and poorly organized, I> did get it pretty well configured yesterday and it is a bit more> user-friendly than it's 1.9 predecessor. Lots more animations and a> bit of streamlining as far as setting up folders, procedures for using> it, etc.> I had gotten so frustrated with the old SW that I just took a> vacation from it for a while; couldn't face it. So I am very excited> to be up and running again and in the 21st century. Just wonder what> will happen next time I have to upgrade, what with new FDA regs.> > > > > > > >

[Guest guest]

Zelda,

I'm absolutely in favor of doing what works and makes you comfortable. Many

people would not/should not do home training, and there are plenty of good

professionals out there to work with them. In our rather large home-based

training group in Atlanta, we learned two requirements that we applied before

accepting participants: 1) Someone in the family had to be organized and

motivated enough to be the IT (identified trainer); 2) the IT could NOT be

actively at war with the client. For anyone who doesn't meet these criteria, I

would strongly recommend working with a trainer--or at least under the close

supervision.

As to requirements to buy BrainMaster equipment through us, if BrainMaster

suddenly stops accepting orders from us without a note from our doctor, that

will reverse a pattern that has been in place since 1998. Haven't seen it

happen yet.

Pete

>

> From: ZELDA BELL <momsneighborhood@...>

> Date: 2006/06/15 Thu AM 09:31:36 EDT

>

> Subject: Re: Re: 2.5 SW

>

> ,

> You know I started to think about this email and I remembered that when I

was beginning to negotiate to buy the BMer that there was a lag in the time my

clinician got back to themto sign off and I called them back and said that

perhaps I could talk to you, instead. I was told that even you would have

problems purchasing it with the new regs. (Because I had thought of going

through you, though their price was really fabulous). So now I am a bit ticked

off at BMer because now I am somewhat committed to return to my clinician on a

more regular, (and costly and inconvenient basis) in order to do the honorable

thing and not make her feel in jeopardy.

> I do have to say though, that when my son started NF five or so years ago,

he was so resistant and violent that getting him to sessions in the first couple

months were very difficult, and dangerous for me. Once I had to almost take the

door off the hinges as he barricaded himself in the bathroom. And, there were

times early on when a training didn't work well and we had to go back

unexpectedly as he had turned into Satan. So, if insurance paid for this, I

would be fine with more supervision for just such reasons. I just can't see

people doing this without knowing what they are doing.

> I mean, there are several family members I would like to work on but would

prefer that they went to someone more knowledgeable first to get some protocols

set first, and then I could reinforce it.

> Zelda

>

> Van Deusen <pvdtlc@...> wrote:

If you buy from BrainMaster directly, you will have to meet that requirement.

Or you can buy any BrainMaster hardware or software through brain-trainer.com

(as you did your first one), and you won't need any of that. Of course you'll

have to pay 10% LESS to buy from Brain-Trainer, but it may be worth it...

>

> Pete

>

> >

> > From: ZELDA BELL <momsneighborhood@...>

> > Date: 2006/06/13 Tue AM 10:10:56 EDT

> >

> > Subject: Re: 2.5 SW

> >

> > ,

> > I am not a clinician. This time buying the BMer, I had to have my

clinician sign off for me, here I didn't when I bought the first one. It is

fair and appropriate for there to be more supervision, but it is a burden for

her, I think. She doesn't even use BMer anymore so I will have to use protocols

estab on another system which she uses.

> > Zelda

> >

> > " St. Clair, MSW " <mastclair@...> wrote:

> > Zelda, what new FDA regs?

> >

> >

> > 2.5 SW

> >

> >

> > Haven't posted anything in ages but I just got the 2.5 BMer SW and

> > though the manual is still absolutely dreadful and poorly organized, I

> > did get it pretty well configured yesterday and it is a bit more

> > user-friendly than it's 1.9 predecessor. Lots more animations and a

> > bit of streamlining as far as setting up folders, procedures for using

> > it, etc.

> > I had gotten so frustrated with the old SW that I just took a

> > vacation from it for a while; couldn't face it. So I am very excited

> > to be up and running again and in the 21st century. Just wonder what

> > will happen next time I have to upgrade, what with new FDA regs.

> >

> >

> >

> >

> >

> >

> >

> >

>

>

>

>

>

>