Potential Scam, Snake Oil: TinAway

[Zimichael]

Kirsten.....

So I read your reply as a simple "NO" correct?! Thus...This has not been tried on any human yet.

Man I don't know how I could quite imagine doing that if I was an inventor working on something like this, and not be just sneaking it on to some volunteer, or relative, or whatever, to at least get a feel for it! But, I guess I'm not a "theoretical" kind of guy. All kinds of wonderful theories have plummeted and burned in the real world...All the whiz kids at Long Term Capital Management come to mind, with their "algorithms of inevitable success". (Ahhh, they just about triggered a 2008/2009 style Financial Crash...a bit earlier on in time. You can Google it, but no need really as my point is clear).

I guess I will just have to wait and see how your "Suppression" is any different from Residual Inhibition, or Masking...as without a John or Jane Doe saying: "Yeah this worked for me and fixed my T", it remains a theory.

Any idea about your timeline? As if you are going to go through years of Phase trials you are well behind Autifony and they may just blow the rest of the competition away completely...especially if our suspicions of re-setting the Tinnitus brain pathways for a while then being able to dump the med, are correct.

*No attachment I can see by the way.

Thanks for the reply, even though not quite that one word I was looking for, Zimichael

 

[lapidus]

Any idea about your timeline? As if you are going to go through years of Phase trials you are well behind Autifony and they may just blow the rest of the competition away completely...especially if our suspicions of re-setting the Tinnitus brain pathways for a while then being able to dump the med, are correct.

Since this isnt a drug like AUT00063 or a medical procedure like VNS, I don't think there are any real phases with this type of product.

 

[Zimichael]

Since this isnt a drug like AUT00063 or a medical procedure like VNS, I don't think there are any real phases with this type of product.

@lapidus ...Guess I'm not following the need for it then

Best, Z.

 

[kirsten puls]

Dear everyone,

Ian spent a while working on this document, which goes into detail about the rationale, and the references illustrate what has been done and what hasn't experimentally - probably the part on complete temporary suppression is what you most want to know. tinAway itself has not been tried yet as a therapy, although I've heard the sounds it can make myself and seen the interface.

You're right that development for an OTC device is different to a prescription drug. After this trial, it goes straight to registration, which Ian estimated as four months (I'm not an expert in this though).

Let me know if you can't see the file,

Kind regards,
Kirsten.

 

[dboy]

'Here comes the science...'

I wish I had the knowledge to offer some intelligent comment on that, but I don't so I thought I'd make a lame joke instead. Thanks for posting it, and hopefully some clever people will be along soon with more worthwhile thoughts.

 

[Visitor1538]

Ah, I want to back this but as many said, it sounds fishy even with all the details. But there has to be a link to why your tinnitus suddenly goes totally silent for some seconds when you hear a specific sound. I don't believe it goes permanently away by listening to some sounds(only temporarily) But if there was a way for the nerve to "think" that frequency were still heard and active without actually hearing the sound.

I really hope some of these trails hits spot on one day, and it just feels so close. Like the last jigsaw puzzle piece that's under the table.

And one other thing, I generally trust doctors who got tinnitus themselves more : P As they are much more invested hehe.

But I really hope these people are genuinely trying to make a breakthrough, not just cash in.

 

[kirsten puls]

Dear Aleks,

I understand your skepticism given the amazing array of things that don't work very well in the field. I guess you have to go with your gut feeling as to whether this is a genuine attempt to find an answer. I can only say that I think they're genuine because I've met them and seen how Ian's years of work have made him emotionally invested in the new model.

The idea behind this is that repeated temporary complete suppression with progressively calm the system (EP pathway) until the feedback loop is no longer active. Whether this will work or not, we can't say. But testing it will give some answers, whether the results are positive or negative. So even if this device is not the solution, the hope is the test will at least advance the science.

All the best,
Kirsten.

 

[Visitor1538]

I'll take your word. It doesn't help to doubt the ones who try new things even though it opens the possibility for scams. I've become more cynical these last years, but I rather waste my money on something that could potentially help others. I'll back some, and if it later on show something of a hope from trails or relief I'll invest more.

A cure would be great(highly unlikely), but relief will be good enough for me. I just want to enjoy reading again. Best of luck.

 

[kirsten puls]

Thanks Aleks. Let's hope this works or provides some answers. And I hope that if it doesn't, you can still end up finding something that will help. Best of luck to you to,
Kirsten.

 

[jss]

Kirsten what is your role with Dr Ian Dixon?

Since it does not look like you will get the financing you need unless you pull off a miracle in 24 days. What is your next step? Why not just release it as a regular app and not a medical device? Why not let some of us try it?

 

[kirsten puls]

Hi Jss,

I'm a medical/science writer and I helped them with the written materials. What will happen if they don't raise enough? There are a few options - of course it will depend on how much is raised in the end. A decision will be made at that point and I will inform everyone. What is clear is that a (legal) test remains the aim, even if it has to be reduced in scope.

Regarding releasing tinAway as a non-medical app, the thing is that the critical part of the app itself is an algorithm for guiding people to find sounds which will suppress their tinnitus (which is therapeutic, hence regulated - please read what Dr. Dixon wrote about the regulation of medical devices). Even without the guidance part, the sound generating system would be regulated if the aim of it was therapeutic, and something like that is clearly not recreational. I hope that's some help,

Kind regards,
Kirsten.

 

[Raindance74]

Your first move should be to change that crappy name "TinAway". Fire the person who thought of that. It reminds me of Quietus, Tinnitus Miracle, etc. You'll never be taken seriously. Although I don't believe it works, look at Neuromonics. That's a name that sounds scientific enough to fool people out of their money, which ultimately is what you and that quack Dr Dixon are aiming to do. All investors should receive a refund if this thing ever reaches development.

 

[kirsten puls]

Hi Raindance,
Well, there's nothing I can do about the name, but at the end of the day, it's whether it works or not that's important. I'm not sure why you think I stand to make money out of this. I wrote the materials, for which I've already been paid. The only stake I have in the project's success is emotional.

Kirsten.

 

[jazz]

Looks like tinAway did not reach their goal--not even close. They raised a little over $5K out of a $100K goal.
Still, $5K is a nice piece of change and those who invested those funds will not get their money back.

https://www.indiegogo.com/projects/tinaway-a-potential-cure-for-chronic-tinnitus​

 

[tokyotony]

I "invested" and am a disappointed no refund.

 

[attheedgeofscience]

I not here to defend the TinAway folks, but for reasons of objectivity, I would like to point out that the funding campaign was a so-called "Flexible Funding" initiative - meaning that all funds raised will be collected even if the final goal of $100k was not reached. This was known from the beginning.

There was never a promise made to refund anyone and indeed they may still try to run the project with a smaller budget.

The following update was taken from the fundraising website:

Dear Supporters,
We've come to the end of the campaign to raise money for a clinical trial of tinAway. The total we raised fell well short of what's required to run the trial Dr. Dixon had in mind, or even to run a small pilot. In order to move forward, Ian and Tony will need to explore other avenues to raise funds and I will keep you updated on how this progresses.
I also hope to get the tinnitus trackers to you within a month when Ian and Tony have finalised them.
Finally, I would like to thank you again - this campaign has shown me that people like yourselves who take action to support something they believe is worthwhile are rare. Your help is all the more admirable and valuable, and we'll keep working to make sure the goal all of us have contributed towards is reached in the end.
Until the next update, you might like to look at http://turnofftinnitus.com/ , our general tinnitus website.
Yours sincerely,
Kirsten.

I have evaluated many financial start-ups in my finance career, and in my opinion, the TinAway team has shown more transparency with regards to their initiative than many other tinnitus researchers have and/or would have done.

 

[tokyotony]

Well, just because it was set up that way, it doesn't mean they HAVE to keep the money. What will they use it for? Not very clear and it does make it seem like they are a scam.

 

[jazz]

I have evaluated many financial start-ups in my finance career, and in my opinion, the TinAway team has shown more transparency with regards to their initiative than many other tinnitus researchers have and/or would have done.

Well, that is laudable!

And, please know, I don't believe the inventor, Dr. Ian Dixon, is a scammer. I respect his professional and educational accomplishments. And I do believe in his sincerity, even if his promise to cure tinnitus appears naive. But it's my opinion that Dr. Dixon was not ready to clinical trial this product. Perhaps, this is why he chose crowdfunding as opposed to traditional funding routes--such as public or private grants, investor groups, venture capitalists, etc.

Most disconcerting about tinAway was its marketing as a potential tinnitus cure. I saw nothing from the crowdfunding campaign or on the company's website that offers scientific evidence the device could cure anything. It was all theoretical, based on "auditory scene analysis" (ASA). But ASA is an unproven construct, and its usage appears designed to facilitate habituation. This does not sound like the cure the inventor had promised. Nor had the inventor attempted to publish anything about the device in any scientific journal. This absence denied critical information to scientists and potential investors. But these communities need to understand how the design and utilization of his device would cure the tinnitus precept. That the tinAway people attempted to explain this lack of scientific transparency from a need to protect proprietary information is not acceptable. This is why we have patents. (And, yes, I searched but could not find any patents for tinAway.)

As any (chronic) tinnitus sufferer knows, "cure" is a troublesome word for many reasons. For example, does "cure" mean habituation where you no longer hear your tinnitus; or does it mean eradication of the abnormal neural activity associated with the tinnitus precept, evidenced in imaging studies like fMRI's and MEG's? Or, perhaps, does "cure" mean something else? How "cure" is defined matters; indeed, it is essential. And yet, the inventor marketed the device as a cure. Cure is a very high bar for any proposed modality--whether it be a medical device, pharmaceutical, or biologic.

While part of me admired the tinAway team's willingness to conduct a clinical trial, the other part wondered why they would chose Indiegogo as a route? And the amount of money expected from their crowdfund appeared onerous. Even sites designed for medical and scientific crowdfunding, such as experiment.com, offer far less ambitious funding projects. Still a nascent field, crowdfunding for science and medicine is utilized as a supplement to traditional funding sources--such as public and private grants.

Still, if the tinAway folks do get their project funded and it actually cured tinnitus, their device will be utilized worldwide by the audiological community and potentially recommended by physicians and tinnitus organizations.

If tinAway truly cures--or even reliably effectuates habituation--Dr. Dixon and his associates will find a way to fund. From great demand will flow even greater profits.


For information on PubMed that discusses auditory scene analysis, please see the following:

http://www.ncbi.nlm.nih.gov/pubmed/17956809

http://www.ncbi.nlm.nih.gov/pubmed/22707935​

 

[attheedgeofscience]

Well, that is laudable!

And, please know, I don't believe the inventor, Dr. Ian Dixon, is a scammer. I respect his professional and educational accomplishments. And I do believe in his sincerity, even if his promise to cure tinnitus appears naive. But it's my opinion that Dr. Dixon was not ready to clinical trial this product. Perhaps, this is why he chose crowdfunding as opposed to traditional funding routes--such as public or private grants, investor groups, venture capitalists, etc.

Most disconcerting about tinAway was its marketing as a potential tinnitus cure. I saw nothing from the crowdfunding campaign or on the company's website that offers scientific evidence the device could cure anything. It was all theoretical, based on "auditory scene analysis" (ASA). But ASA is an unproven construct, and its usage appears designed to facilitate habituation. This does not sound like the cure the inventor had promised. Nor had the inventor attempted to publish anything about the device in any scientific journal. This absence denied critical information to scientists and potential investors. But these communities need to understand how the design and utilization of his device would cure the tinnitus precept. That the tinAway people attempted to explain this lack of scientific transparency from a need to protect proprietary information is not acceptable. This is why we have patents. (And, yes, I searched but could not find any patents for tinAway.)

As any (chronic) tinnitus sufferer knows, "cure" is a troublesome word for many reasons. For example, does "cure" mean habituation where you no longer hear your tinnitus; or does it mean eradication of the abnormal neural activity associated with the tinnitus precept, evidenced in imaging studies like fMRI's and MEG's? Or, perhaps, does "cure" mean something else? How "cure" is defined matters; indeed, it is essential. And yet, the inventor marketed the device as a cure. Cure is a very high bar for any proposed modality--whether it be a medical device, pharmaceutical, or biologic.

While part of me admired the tinAway team's willingness to conduct a clinical trial, the other part wondered why they would chose Indiegogo as a route? And the amount of money expected from their crowdfund appeared onerous. Even sites designed for medical and scientific crowdfunding, such as experiment.com, offer far less ambitious funding projects. Still a nascent field, crowdfunding for science and medicine is utilized as a supplement to traditional funding sources--such as public and private grants.

Still, if the tinAway folks do get their project funded and it actually cured tinnitus, their device will be utilized worldwide by the audiological community and potentially recommended by physicians and tinnitus organizations.

If tinAway truly cures--or even reliably effectuates habituation--Dr. Dixon and his associates will find a way to fund. From great demand will flow even greater profits.


For information on PubMed that discusses auditory scene analysis, please see the following:

http://www.ncbi.nlm.nih.gov/pubmed/17956809

http://www.ncbi.nlm.nih.gov/pubmed/22707935

I agree more or less with all of what you wrote. My position is more of a comparative one: I'd rather support the TinAway folks than people who sell patches that are placed behind a person's ear.

The idea/model behind TinAway seemed sufficiently different from other sound suppressive therapies that it caught my attention (ie. the concept that tinnitus disappears in the teenage years in some children). I had not heard that before.

After my trip to Switzerland, I have also had to readjust my own worldmap view of future treatments. There may be instances of tinnitus that - even with the benefit of future medical advancements - simply cannot be cured pharmacologically. It may be that cures will, in some cases (need to) take on a different approach. An approach which has not been developed yet. Sound suppression mechanisms would not be my first choice in that regard - agreed. But it could be one potential option. And if we don't explore, we will never find the answer.

Another topic which is always in the back of my mind is that of side-effects: suppose sound suppression was to end up as a potential treatment, the side-effects would likely be negligible and the treatment non-invasive. Quite different from Trobalt and brain surgery.

 

[Zimichael]

Perhaps it is time for TinAway folks to consider our offer of "free trialees" for their "device". If the big Kahuna, official trial route bombed, why not go the potential "wildfire" approach of a successful treatment being spread word of mouth by people like us?! If they have the device, and it works, the tsunami of orders would make all this other folderol totally irrelevant.
And I don't buy it that a "sound device" has to be FDA approved before it can be sold, or tested, or wrapped in a blanket... Just look on the internet for five seconds and see how that premise does not apply!

Best, Zimichael

 

[kirsten puls]

Hello all,

As you all know, the Indiegogo campaign didn't succeed. However, it is still a starting point and Ian still hopes to move forward and do a pilot trial and is working towards that end. Discussions are taking place and when I know the result of them, I will let you know.

All the best, Kirsten.

 

[Raindance74]

I knew this was a joke. People are so desperate they'll throw their cash at anything. A fool and his money are soon parted.

 

[kirsten puls]

Dear Tony,
Since the trial we planned cannot be funded, and we are trying instead for a small pilot, if you feel you would like a refund, so to speak, we could arrange it I think. You can keep the radio clip of course. Just email and let me know.
All the best,
Kirsten.

 

[NeverLoseHope]

Don't get me wrong I am sure all off these people want to find us "the cure" but sadly some for the wrong reasons. R&D takes a lot of time and CASH, But the rewards for finding it is going to be vast as we all know. I have always had the hope that there is a drug out there that was developed for something else that is just waiting to be linked, that losing T was a side effect to taking it. In the same way Viagra was ,and look how big that has become (no pun) hence over the years I have tried so many things.

11 years ago I when I first went to the Dr I was told turn your radio up a bit more. now go away. Thankfully there is more advice about now with groups like this and my own and many others I read.

I get lots of referrals, and get very cross that some people have not even been offered Serc tablets for Meniere's or a test for thyroid problems. Two things we know can cure T. It is far to easy to say go away there is no cure. And leave people with no hope. There are countless companies working on this and I am sure in the next 5 years, something will finally work. Hence I keep the faith and will not give up hope.

Thanks for reading

 

[Goofpod]

I am blown away by some of the negative responses I've read in this thread. A few of you in particular have been so sarcastic, I can only think you've been disappointed so many times that you've become terribly cynical. That's a shame. It seems you're no longer open-minded toward promising research.

Having attended tinnitus workshops in San Francisco directly connected with UCSF Medical School, and hosted by a highly respected senior doctor who has tinnitus herself, I'm convinced Dr.Dixon's research is not only valid, but very promising. Do the homework, look at the studies he references, gather the facts. There's no attempt at fraud here, only a genuine long-term effort at finding a cure for tinnitus. Yes, a cure- based on solid science and research.

The fact that they are forced to fund their additional research and development through crowdfunding is unfortunate. That speaks to the lack of mainstream concern in the medical community, and society in general, toward tinnitus. Basically, if you don't have it, it's just not that important.

Crowdfunding is a very difficult way to raise funds based simply on an idea, or speculation. An established product that is glitzy, and cool, is far easier to succeed with them trying to cure an unimportant ailment. I ran a KickStarter campaign for a very cool product and expected to raise a fortune, but due to several circumstances we fell flat and failed. Go to KickStarter and search for Glo-Blades Skating on Light! Even with such a flashy product as a reward the crowdfunding campaign was extremely difficult. I can't imagine how I would be able to raise funds with only an idea to cure tinnitus. And, as a backer I would never expect a refund after committing to the venture. It simply doesn't work that way.

Dr. Dixon and Company, if you're still paying attention to this thread: please continue with what you're doing and if there's any way I can help I'd be happy to participate. I'm still struggling to raise funds for Glo-Blades (my own venture) but this tinnitus has been with me for a couple of years now and I'm willing to try anything. I sincerely appreciate the devotion, time and effort you've put into this project. Please don't give up over the cynicism of a few. Keep the faith!

And, Kirsten: thank you so much for your unbiased help and objectivity in furthering this cause. Happy new year!

- Ralph

PS: as to readily disseminating the TinAway prototype in the field without government approval, that would potentially be a suicidal business decision. Additionally, after devoting nearly a decade of professional research and personal funding toward any product, it absolute makes sense to keep it close for IP protection. Hopefully, someday Dr. Dixon will recover some of the resources he's put into this.

 

[jazz]

Having attended tinnitus workshops in San Francisco directly connected with UCSF Medical School, and hosted by a highly respected senior doctor who has tinnitus herself, I'm convinced Dr.Dixon's research is not only valid, but very promising. Do the homework, look at the studies he references, gather the facts. There's no attempt at fraud here, only a genuine long-term effort at finding a cure for tinnitus. Yes, a cure- based on solid science and research.

Well, I do hope you're right! We are all seeking relief, after all.

I've not found any evidence that their specific treatment will work. If you have any citations, please post.

Thank you!

 

[Yan]

I am new at this forum, but I have read this whole thread.
I think there are 2 possibilities. I truly want to believe in the second one.
a) Kirsten and other two doctors are extremely smart people. Came up with an idea: develop an app to cure T. And prepared a very interesting presentation, backed it up with smart sounding scientific thesis. Why? To make 100K in 3 months. Very evil. But hey, maybe placebo effect will kick in and it will help some. Even if it helps only one - 100K would be worth it, right?

b) Kirsten and doctors are good willing people. They really invented something new. They have tested it, but won't tell you. Why? Because if/when they succeed there will be big corporations suing them, to try to take them away of the market. And posting something like "we know it's illegal, but we tested on our friends and family" on public forums will be a perfect evidence against them in court. Simply put they are afraid of witchhunting. But they are trying. Trying to do it the lawful way.

I really hope b is the case.
I am programmer myself, know some sound synthesizing theory and, to me personally, research seems very legitimate.
Kirsten, if you still visit this forum. Please ask Doctors to share the algorythm/code somewhere on github or any other open-source communities. You might afraid that someone will take this away from you and make their own intellectual property, but if you are really good willing people, even if it helps to cure at least someone your work will be appreciated. Otherwise it will just end up in dead end.

I am more than willing to participate in a study and, if needed, help to program any type of software/application. I am very much open-minded and I want to believe.

 

[Yan]

Any programmers here? Just figured to throw in here.
I was brainstorming about this new approach yesterday the whole day.
In computer programming there is a notion of recursive function, and it can run forever until the set condition is met. I think it might be totally possible that the loop those doctors are trying to break is the same analogy, where the condition stopping the loop would be identifying the object in the neural library based on the audio frequency it is receiving.

Speaking in programming language, according to the theory that is what tinnitus process looks like in the brain:

function identifyObject(inputFrequency) {
    for each (item in neuralLibrary) {
        if (item.frequency == inputFrequency) {
            break;
            return item;
        }
    }
}

that "for each" line runs continuously in our brain.
I think that is what doctors are trying to achieve. To insert a new object model with the frequency into the brain library, so the condition will be finally met for tinnitus function.
But... won't it be helpful for the brain if you support that object by an extra property/explanation?
That is what happens when people hear unidentified sound and they ask "What was that?" or "What's that sound??". They need further explanation to make sense of the observation: "Oh, it's just Bill testing his new drill" or something like that. Now observed object is identified by human, makes sense. The function identifyObject is done and doesn't need to run for this observed object.

My theory is that in order to teach the brain the sound frequency you have also "explain" it what that is. At least give it a visual feedback. Make sense of it.

I played with sound waves last night. I chose sine wave - why - because it is "smooth" shaped and figured it wouldn't bother my head that much. I was just randomly changing frequency on low (relatively) volume. I have LF hearing loss in my right ear, but there was something interesting happening: on around frequency 93Hz I started to feel weird sensation inside my skull, right under my ill ear. Inner ear was that? I don't know. Maybe I had that sensation when I was doing my audiograph test and just never noticed. But the sensation was sure interesting. I fired up Spectrum analysis tool for the visual feedback and "taught" my brain a little bit, explaining something "Feel that? - That's what sine wave at 93Hz looks like". Than I fired up LFO (low frequency oscillator). Pretty much trying what the folks were talking about here. After an hour my head was just tired of this extratellestial noise and I stopped.

Maybe there is something in this study. If only they could share more of insights on their algorithms.

 

[Steve]

@Yan I am genuinely interested in any audio approach, it's my thing you would say.

There were 2 main issues with this product / trial for me.

1. The name is absolutely terrible and sounds like a scam (I don't think it was a scam, they were far too open)

2. There was zero test data to base a trial on

You can argue about whether it was ethical or not but there were no hurdles to making an observation about how a sound had an effect on a patient in order to get some preliminary data. After all, you don't have a medical device if it doesn't do anything and sound isn't something that is regulated. A simple internet based study could have worked and there are others that have done something similar so there are precedents.

I'd be interested in looking at what you were doing, do you have it to share / what program are you using? (I use Cubase and Reason, may be buying Logic soon)

If we were to play with this and demonstrate a working theory I would be happy.

 

[Yan]

@Steve I agree with scam theory. In the post above I express my opinion on the company.

1. TinAway is absolutely terrible name and I hope that 3 nerds just don't know how to market the product.
2. I think they might have test data, just overprotective in public. It would be illogical/irrational to get that far with the theory they are describing. Folks do seem to be smart.

They have tested it, but won't tell you. Why? Because if/when they succeed there will be big corporations suing them, to try to take them away of the market. And posting something like "we know it's illegal, but we tested on our friends and family" on public forums will be a perfect evidence against them in court. Simply put they are afraid of witchhunting.

I used Ableton, I believe they have unlimited trial that just doesn't allow you to save made project, but it doesn't really matter what software to use as test was pretty basic. What really matters is good quality sound monitors. Why don't you give it a try? According to ASA you don't have to match your T sound. You have find a unique "tinnitus code" that will work for. But even then, does it have to be repetitive? What envelope to apply? That is what I wonder most.

Just play around with pure tones and try to "explain" your brain what you are hearing.