Potential Scam, Snake Oil: TinAway

[dboy]

Kirsten and her colleague have indicated that they wish to go 'by the book'. The cynic in me wants to suggest that doing so would probably secure a salary for them for a year or two, regardless of trial results. If so, crowdfunding to secure a salary is an interesting concept, ethically speaking. It is great that ideas and research directions are being generated, but most tinnitus sufferers have been around the block a fair bit with putting money and hope into things that don't quite work out. Perhaps it would be fairer to get funding by more conventional routes?

Just thinking out loud. Not many tinnitus companies put so much effort into communicating on forums. I kind of wish they did, but without the idea hovering in the background that they are asking for money.

No offense intended, and I do hope I am wide of the mark.

 

[RaZaH]

I do hope I am wide of the mark.

I think you are spot on.

 

[kirsten puls]

Dear dboy,
Here's a link to some of the FDA regulations of medical devices (it's they who decide if your device is medical or not and how you may test it).
http://www.fda.gov/medicaldevices/d...investigationaldeviceexemptionide/default.htm

The trial costs are:
If we can manage to raise enough money, we'll run a trial in 30 to 35 patients, for about 9 months, in three stages.
Study costs include investigator fees, insurance, site payment, documentation, data handling, statistician, prototype validation testing, software quality audit, trial design, project management, travel costs, ipads and good quality headphones for the subjects to use during the trial.

As for salary, there are the 2 engineer-inventors (Ian and Tony) who both have other full time jobs and me, a freelance writer who also has other work in addition to doing this. There's no one else involved.

Kind regards,
Kirsten.

 

[SoulStation]

Do you Ian or Tony have Tinnitus? PS I'll try your app or be on this trial. I'm already so desperate I'm taking a anti epileptic medication to try to calm down the noise inside my head that's taken away so much.

Dear dboy,
Here's a link to some of the FDA regulations of medical devices (it's they who decide if your device is medical or not and how you may test it).
http://www.fda.gov/medicaldevices/d...investigationaldeviceexemptionide/default.htm

The trial costs are:
If we can manage to raise enough money, we'll run a trial in 30 to 35 patients, for about 9 months, in three stages.
Study costs include investigator fees, insurance, site payment, documentation, data handling, statistician, prototype validation testing, software quality audit, trial design, project management, travel costs, ipads and good quality headphones for the subjects to use during the trial.

As for salary, there are the 2 engineer-inventors (Ian and Tony) who both have other full time jobs and me, a freelance writer who also has other work in addition to doing this. There's no one else involved.

Kind regards,
Kirsten.

 

[kirsten puls]

Hi SoulStation,

I only have a bit from time to time in my left ear (well, that's what it seems like). My sister, mother-in-law and several friends do, though I think no way near as desperate as yours sounds. My sister would be interested in trying it when it's available. If we can get the trial funded, you would go through your doctor to become enrolled, as would she, because it will be run independently of us.

Kind regards,
Kirsten

 

[Raindance74]

Kirsten, if you can provide at least one published report with data supporting your hypothesis, I'll sign up through my primary care doctor asap. I'll even buy you a pair of sunglasses to keep that glare out of your eyes.

 

[kirsten puls]

Hello,
That would be a list of papers on 1. suppression, 2.ASA model of hearing, 3.up and down regulation of the EP pathway. I can compile you a list over the weekend and get it to you on Monday if that's OK as (it's Friday evening here now) - I think my sunglasses are in my hair somewhere ....

 

[dboy]

Dear dboy,
Here's a link to some of the FDA regulations of medical devices (it's they who decide if your device is medical or not and how you may test it).
http://www.fda.gov/medicaldevices/d...investigationaldeviceexemptionide/default.htm

The trial costs are:
If we can manage to raise enough money, we'll run a trial in 30 to 35 patients, for about 9 months, in three stages.
Study costs include investigator fees, insurance, site payment, documentation, data handling, statistician, prototype validation testing, software quality audit, trial design, project management, travel costs, ipads and good quality headphones for the subjects to use during the trial.

As for salary, there are the 2 engineer-inventors (Ian and Tony) who both have other full time jobs and me, a freelance writer who also has other work in addition to doing this. There's no one else involved.

Kind regards,
Kirsten.

Again, I apologise if I seem argumentative or distrustful. Nevertheless, you do not state that none of the money generated by crowdfunding will end up being paid to yourself or your colleagues. I do not doubt that you are all working hard for this. I am merely pointing out that this is a valuable career opportunity for all of you. If 'Tinaway' proves not to be the answer then you all will have gained valuable skills and experience that may well then be a springboard to working for more established companies.

I am not claiming that you are not genuine, only pointing out that you stand to benefit from your trial going ahead, regardless of whether it is a success in treating tinnitus. It is win-win for you, only win-lose for the funders.

In view of this, there are things that you say that are likely to sound alarm bells for folks who have had tinnitus for a while and seen how the cottage industry that preys on them works. You suggest several times that your device might cure tinnitus. Not just help to treat it but take it away completely! But you present no evidence to back this up. I realise you hope the trial will provide evidence, but it simply is not credible to make such extravagant claims without some basis other than a PhD. theory.

I hope you have a good weekend and are not feeling too frustrated by the attitude of folks like me. It is nothing personal, just words of caution for fellow sufferers.

 

[Zimichael]

Kirsten... Please excuse me if I am just being plain dumb here, but could you please make one simple thing clear to me.

Have you, or have you not, tried this device, algorithm, idea, treatment, whatever...on any human being with tinnitus - yet, ever, right now, whenever?

Thank you. Zimichael

 

[Steve]

To summarise:

• You have a hypothesis, which has not been tested
• You have a theory on tinnitus which is not validated or peer reviewed
• You have produced an app through this theory and hypothesis
• The app is a sound generator
• You have registered the app as a medical device; although
  • You don't yet know if there is a medical application due to the lack of data or tests

I still can't see the barrier to testing your hypothesis outside of the app - which is all you have registered as a medical device. You can test a persons reaction to sounds, in a controlled environment where exposure is limited so no noise induced damage could take place.

Testing the individuals reaction to the sounds you are making should have been the cornerstone to your hypothesis, testing it so that it can be refined, all I can see at this time is an idea.

You could test this with participants from this board, get people to listen to a sound sequence and report back if they feel it has a positive or negative effect on their tinnitus - completely outside of your medical app. Heck, you could even upload a few samples to YouTube to get feedback (instructing they are for tinnitus in the range of xxHz).

It is a tall order to ask for money at this time, conjecture with no experimentation, you are at the very early stages of the scientific process.

So how about putting your money where your mouth is and testing the hypothesis right here?

Steve

 

[Zimichael]

To summarise:

• You have a hypothesis, which has not been tested
• You have a theory on tinnitus which is not validated or peer reviewed
• You have produced an app through this theory and hypothesis
• The app is a sound generator
• You have registered the app as a medical device; although
  • You don't yet know if there is a medical application due to the lack of data or tests

I still can't see the barrier to testing your hypothesis outside of the app - which is all you have registered as a medical device. You can test a persons reaction to sounds, in a controlled environment where exposure is limited so no noise induced damage could take place.

Testing the individuals reaction to the sounds you are making should have been the cornerstone to your hypothesis, testing it so that it can be refined, all I can see at this time is an idea.

You could test this with participants from this board, get people to listen to a sound sequence and report back if they feel it has a positive or negative effect on their tinnitus - completely outside of your medical app. Heck, you could even upload a few samples to YouTube to get feedback (instructing they are for tinnitus in the range of xxHz).

It is a tall order to ask for money at this time, conjecture with no experimentation, you are at the very early stages of the scientific process.

So how about putting your money where your mouth is and testing the hypothesis right here?

Steve

Right on Steve!!!

I have an additional idea...

If this stuff is not given any "human testing" at all...and given all that has been offered, suggested and said here in this thread, I can personally say:
1. It is all a major scam, or...
2. The people involved are hoping to financially free-load off a category of suffering we know only too well and don't particularly appreciate being used as a pissing pole.

Thus my idea is...that if Steve's so apt last phrase is ignored, we unleash ATEOS on them with his inestimable powers of financial/truth evisceration. And of course many of us could do some rather un-pretty advertising ourselves.

Yeah this hedge around the bush stuff is beginning to piss me off.

Zimichael

 

[dboy]

I think it is worthwhile to critique the approach these folks are taking, but lets not slide into hating them. They are, after all, looking for an answer to tinnitus. And however suspicious some of the sales patter might seem, it is at least possible that the main man is onto something with his theory.

Besides, getting pissed off is bad for your tinnitus.

 

[RichL]

I agree totally with @Steve and @Zimichael , I have been holding back posting on this thread because I thought I was just not getting something but @Steve is right, how on earth can you ask for financial backing on an unproven hypothesis?

Honestly, in business you get an idea and ask for financial backing to get it up and running! this is not a business idea, it is an unproven hypothesis for a medical condition that you haven't even done any scientific experiments to see if it works!

There is allot of guinea pigs here that will be very accommodating!

Excuse us if we are skeptical!

Rich

 

[Zimichael]

I think it is worthwhile to critique the approach these folks are taking, but lets not slide into hating them. They are, after all, looking for an answer to tinnitus. And however suspicious some of the sales patter might seem, it is at least possible that the main man is onto something with his theory.

Besides, getting pissed off is bad for your tinnitus.

@dboy ...Ha ha, yeah, OK maybe my "polite" Brit background is getting a bit frayed by near total sleep deprivation for past 8 days (Benzo taper). However, IF this is a scam, or even a semi-scam trying to make money on what is sounding like a "theory" at best right now...does anyone like someone else taking advantage of their suffering to make money out of it under false pretenses??? I doubt it.
And yes, the onus here is clearly on TinAway for more disclosure and say why the good, free, willing, coherent, ideal, non FDA (or whoever), non regulated, non restricted, volunteer members of this Forum can't try their 'completely untested'??? app...Hell we are not even talking about a bleedin' med with potential awful side-effects like Retigabine. This thing will have a "volume switch" possible = 100% more user/guinea pig friendly!!!

So, I stand behind the intent of my prior post completely, though will indeed try and be a little more civil. Just a little though! *(And getting pissed off actually makes me forget my tinnitus more easily, so maybe I should really go for it! It may even give me some better 'residual inhibition' than this app....Ooops, I said I was going to be more polite. Sigh!)

Thanks... Best, Zimichael

 

[attheedgeofscience]

They are, after all, looking for an answer to tinnitus.

I think that's a fair point. And also something I echoed earlier on.

I am neither here to endorse the funding campaign, nor to excessively criticize it. After having reviewed all the material available on both websites, I would like to mention the following:

1) There is a reasonable amount of transparency (cost break-down and project timeline).
2) The project seemingly has the endorsement of the Lord Mayor; perhaps he could endorse it "fully" by making a symbolic donation of eg. $1000 or $5000...?
3) The timeline is aggressive (with a clinical trial already set to start later this year - "nice" and something tangible instead of "we will be working on this for the next 5 years before we are ready...").
4) I can only assume(?) that, a project run by people with Ph.Ds, must have some substance to it - otherwise they would not (or rather - should not) consider the funding campaign.
5) Few, if any, side-effects from treatment (unlike eg. drugs).
6) A remedy easily distributed(?) to the masses via download (if it works!).

However, as I was the first to point out, the whole project hinges on the theory actually working (needless to say) ie. find a "victim" and test it first (just once, at least!). And it is still unclear to me whether - "written inbetween the lines" - the project members actually have some kind of "proof" which they are not explicitly mentioning at this point. From the demonstration video, there seems to be some kind of prototype already in place - but of course, that could simply be purely illustrative...

As it happens, I actually have a fair bit of knowledge of start-ups. My Father represents an organization which since 2010 has raised €56 million in capital for start-ups that had no capital whatsoever to begin with. The capital raised essentially represents their intangible asset value ie. capital raised purely because investors are willing to invest in the start-ups because of the business potential behind the ideas. The trick is to select those good ideas and get them visible in front of big sponsors. The raised capital of €56 million proves the concept works, but also that there really are some good ideas out there...

So I am a bit on the fence on this one. I'd like to see more evidence, but I recognize the difficulty of getting funding for start-ups, and I appreciate the effort the small team has so far put together in terms of the all the material available on their websites. But... at the same time, sound suppression is not a new topic in terms of tinnitus treatments. But of course their approach is.

Financially speaking, the problem with crowdfunding is that it is funding by donation (and not by investment). Had it been by investment, the investors would be running a risk, but also get the chance of harvesting the fruits if the business idea survives. I'd like to see the possibility of getting eg. a guaranteed spot on the clinical trial for those who pay the $10,000,- item (as an example - and provided it is legal to do so). This would add a bit of payback to the donation.

As with any tinnitus treatment, I of course hope that it will be successful. This one included.

 

[nogood]

hmmmm....
you guys want 100k to test an mobile phone app which is based on on unproven technology, the app or the underlining technology can be patented. From the choice of the flatform i am guessing that that app will not be opensourced, in cause if it succeeds and app/algorithm is patented you guys will be making money.. so what does the public /suffers get, possibly a just paid app???

why dont you skip the iphone or ipad automatically 1k plus cut per person who will be in trail, so 30 to 35 k cut in cost. i can volunteer to do these for free- validation testing, software quality audit, trial design [off course during weekends only ] or i can find people who would do it for free.

my mind saying...

Dear dboy,
Here's a link to some of the FDA regulations of medical devices (it's they who decide if your device is medical or not and how you may test it).
http://www.fda.gov/medicaldevices/d...investigationaldeviceexemptionide/default.htm

The trial costs are:
If we can manage to raise enough money, we'll run a trial in 30 to 35 patients, for about 9 months, in three stages.
Study costs include investigator fees, insurance, site payment, documentation, data handling, statistician, prototype validation testing, software quality audit, trial design, project management, travel costs, ipads and good quality headphones for the subjects to use during the trial.

As for salary, there are the 2 engineer-inventors (Ian and Tony) who both have other full time jobs and me, a freelance writer who also has other work in addition to doing this. There's no one else involved.

Kind regards,
Kirsten.

 

[kirsten puls]

Dear Everyone,
I'll put your questions to Ian - he's been writing an FAQ for you. But you have some interesting suggestions. I can't speak for Ian, so as I said when I've spoken to him about them I'll get back to you.
All the best,
Kirsten.

 

[nogood]

since they are only talking about an mobile phone app.. if they go opensource ... it should not be a problem. There are so many variants of opensource licenses can pick one of the which actually will help them.. also no restriction that opensource software can not be patented. Its one way i can think off in which they can give back to people.

Financially speaking, the problem with crowdfunding is that it is funding by donation (and not by investment). Had it been by investment, the investors would be running a risk, but also get the chance of harvesting the fruits if the business idea survives. I'd like to see the possibility of getting eg. a guaranteed spot on the clinical trial for those who pay the $10,000,- item (as an example - and provided it is legal to do so). This would add a bit of payback to the donation.

 

[attheedgeofscience]

since they are only talking about an mobile phone app.. if they go opensource ... it should not be a problem. There are so many variants of opensource licenses can pick one of the which actually will help them.. also no restriction that opensource software can not be patented. Its one way i can think off in which they can give back to people.

The legality I mention has to do with the clinical trial itself. This would probably be required to be equal opportunity - in which case you cannot "reserve" a spot (even if you pay for eg. the $10,000,- item from the pick list...). And there are only so many "seats" available...

 

[nogood]

From my understanding a drug get approved by fda it goes like
Development -> clinical trail -> public
I guess this generally ok for a drug..

Wht these guys doing are trying to get fda approval before it reaches the public , for an app that produces an audiometry signal. The essence of the app they are talking abt is the algorithm not the app itself. If am not wrong they will patent the algorithm and get approval for app from fda.
If you have the algorithm anyone can build an app. Like one written by one of the members for acrn on
http://www.generalfuzz.net/acrn/
So i order to protect their self interest and profit tinaway wants to patent it and get fda approval at the same time.
And they choose to follow regulations for fda. Cause patenting application does not really require same rules as fda application.
But i dont really understand why they approach for crowd funding when their motive is really making money.

Answer to ur question.:
Making the app or algorithm opensource would would actually allow people outside the clinical trial use the app. Lots of licensing formats available to restrict other companies from copying and using it for profit. To me i see it boiling down to software and algorithm nothing more and for it 100k crowd funding doesn't really make sense.

The legality I mention has to do with the clinical trial itself. This would probably be required to be equal opportunity - in which case you cannot "reserve" a spot (even if you pay for eg. the $10,000,- item from the pick list...). And there are only so many "seats" available...

 

[kirsten puls]

Dear all,
Ian and Tony don't have a choice about registering w FDA. It's the FDA which decides what is a medical device, what requires which sort of approval process. People have been pinged for this in the past
http://www.ihealthbeat.org/articles...irst-inquiry-of-unregulated-mobile-health-app. Do you have any regulatory people in your forum?

As for your suggestions about how things might be done differently, I'll hopefully talk to Ian tomorrow and find out what he thinks.

In the meantime, please find attached part I of the FAQ which we hope will cover some of the things you've been asking. More to come!
Kind regards,
Kirsten

 

[attheedgeofscience]

Dear all,
Ian and Tony don't have a choice about registering w FDA. It's the FDA which decides what is a medical device, what requires which sort of approval process. People have been pinged for this in the past
http://www.ihealthbeat.org/articles...irst-inquiry-of-unregulated-mobile-health-app. Do you have any regulatory people in your forum?

As for your suggestions about how things might be done differently, I'll hopefully talk to Ian tomorrow and find out what he thinks.

In the meantime, please find attached part I of the FAQ which we hope will cover some of the things you've been asking. More to come!
Kind regards,
Kirsten

Dr. Puls, I read your FAQ attachment. For the part regarding "we can't just let people try it outside a clinical trial", there is a comment at the end saying "We would welcome any positive comments on this". My comment - although I am probably going around in circles at this point and begining to annoy you - would be to investigate a release of responsibility form. When I was scheduled to have the AM101 injections performed outside of the clinical trial with consequent guarantee of getting the real drug, the doctor here in Germany informed me I would probably need to sign such a form. However, in the end we never got that far because Auris Medical would no release the drug for off-clinical trial purposes. But that shows you can do "things" outside of a clinical trial (although admittedly there is not a perfect comparison between your situation and the one I was in ie. Esketamine is already in use for other medical purposes).

I suppose at this point, it has become pointless to discuss the matter as you guys have already initiated your funding campaign. But that would have been my thoughts. I appreciate that you guys want to do this the proper way as Dr. Dixon states (ie. "ethical approach"). I would also like to mention that you guys don't owe me/us any explanation as such. This is your project, and you have every right to pursue the funding that you choose (just like anyone else would). At the end of the day, nobody is forcing anyone to donate anything to your project. However, from an investor point-of-view, I would not even touch your project with a pair of iron tongs (I wrote the same thing for the IPO of Auris Medical about two months ago). By that, I don't mean to say that I believe your idea/project is terrible, I just mean to say that there is not enough substance in what you have presented to allow me, personally, to engage in TinAway. As an investor, why would I invest $10,000,- in a project with little predictability of a successful outcome, when I can invest $10,000,- in another project with an almost guaranteed outcome of 7, 8, 9, or even 10% ROI? Not to mention the funding for TinAway is not an investment, but a donation - which financially speaking is equivalent to a negative ROI.

I believe if you had been able to provide some evidence of the ASA model working in practice beforehand, it could certainly also benefit yourselves in your funding campaign (needless to say). It would make the case more robust, and could be an important "selling point" when addressing the public and hence potentially increase funding.

As the moment, the funding campaign has raised $2,655,- in 8 days of funding. That's an average of $332 / day. With 53 days remaining, the total funding using that average would come to 53 * 332 + 2655 = $20,244. And that's far short of the goal of $100,000,- (but of course funding can vary widely - either way). Getting a few (extra) tweets and facebook likes might help spread the awareness.

I wish you good luck. I hope you will be sucessful.

 

[attheedgeofscience]

Do you have any regulatory people in your forum?

Not to my knowledge, but you could ask member ResonanceCEO (M.D.) for his opinion on how to approach this ie. how to conduct initial investigations for medical products. I don't think he joins the forum that often anymore (if at all). But he did in the past...

 

[erik]

Whether this product is legit or not, it has a terrible name that sounds scammy.

 

[lapidus]

Whether this product is legit or not, it has a terrible name that sounds scammy.

That was my first thought too. Sounds just like "Soundcure", "UltraQuiet Therapy" or "Mutebutton". Catchy names, but totally unprofessional.

 

[kirsten puls]

Dear All,

I spoke to Ian today who said he really has explored all the options. That there are no waivers to allow access (in cases like these) and you can't accept money for access to an unregistered drug, i.e., you can't buy spots on a trial. Ian said the guy who advised him is ex-FDA and ex-TGA and now an expert consultant in the regulation of med. devices.

Thanks very much for the best wishes, attheedgeofscience. Let's see how it goes.

Kind regards,
Kirsten.

 

[dan]

TinAway ??? Really ?

 

[Steve]

TinAway ??? Really ?

It is a terrible name, which does not provoke a positive reaction from tinnitus sufferers. Maybe they should see this as vital market research to change it to something less gimmicky.

 

[Zimichael]

Kirsten...

Thank you for the extensive list of FAQ type answers...though please excuse me if I am still being a dumb Ozark hick here, but can you just make this one question I had, clear to me with as simple "Yes/No" answer? Id' appreciate it:

Have you, or have you not, tried this device, algorithm, idea, treatment, whatever...on any human being with tinnitus - yet, ever, right now, whenever?

Also, I have to fully agree with the comments @attheedgeofscience made about the "investing" aspects. I also look at 'left field medical type start-ups' (in a much less educated fashion than him!) but I know some basics, and I too would consider your funding outreach situation a "donation".

Anyway, hoping you will answer the question in bold above, just so I'm clear...even if everyone else is already.

Best, Zimichael

 

[kirsten puls]

Dear Zimichael,

Yes - there is experimental work and observations to back up the different facets that it's based on. We spoke already about the group doing full suppression (but only temporary) with the sorts of sounds tinAway is capable of producing, but no one's been experimented on with tinAway specifically for the reasons mentioned last time. Additionally, there's work on the ASA model of hearing, matching, EP levels etc. which are the basis for the rationale.

I'm attaching the reference list (not the whole one from the thesis, unless you really want it?)

All the best,
Kirsten.