Potential Scam, Snake Oil: TinAway

[Steve]

I have some questions too,

What you have here is a theory, correct? You have not tested it at all?

You are funding to conduct the very first trial without any data to confirm if it will work or not?

I appreciate that you have developed and are marketing as a medical device, but you can still test the principles behind the device to see if it indeed has a permanent effect on tinnitus, to me this would be a pre-requisite to funding. I don't understand how you are aiming to get crowd funding for an idea that may not work? This sounds more to me like a candidate for the funding streams available for proof of concept / proof of model / taking a concept to market - at your stage of development, if I could prove my concept, I would qualify for funding from a variety of sources with the product.

I cannot see anything that differentiates this from Residual Inhibition, you seem to be instead varying the sound delivered to confuse the brain, not let it get used to a sound. Explain to me please if I am wrong, and don't worry about getting too technical if needed.

As it is a sound therapy, delivered by a fairly simple method (iDevice), I see no barrier to conduct a trial with volunteers at all (and as I'm typing ATEOS has already summed that above.).

 

[James White]

Well that "quote" dinagamabob did not work very well! My Gremlins are back, dirty scumbags...

Her again Kirsten re your "website unlinkability" thus our inability to see it:

Ummmmmmmmmm... just copy and paste the site address you can obviously find and see in a new post and don't bother to make it a "link". We have the capacity to paste it into the browser address bar and hit "enter".

Thanks much, Zimichael

Users with less than 1 posts (plus need to be registered for 1 day) can't put links to prevent spam

 

[Zimichael]

Totally agree with @attheedgeofscience ...and @Steve ...above!

Oh, and in reference to children. Do I count??? I got T from noise exposure at age 6 and it never went away (that was 58 years ago). Is that "childhood"? If so so I am personally not that impressed with the connection and likewise don't see the relevance.

@James White ...Oh OK re "link posting", but I was referring to not trying to make link...just type the quoted address and let me cut and paste it to the address bar. Even leave out the www. or whatever, as we can figure that part out. Does not seem like the 'Posting Software Uberlord' would kick that out would it??? If so I stand humbly enlightened.

So Kirsten, please try some imaginative posting techniques or just do it in a Conversation to one of the moderators as I'm sure they will then swing it our way.

Thanks all... Zimichael

 

[lapidus]

Same here @Zimichael I got T when I was 11 and it never went away. Never heard of this kids-theory either and serioulsy doubt it.

And also agree with the above statements. Why don't you just test it?

 

[attheedgeofscience]

I believe this is the link for the trial (which could not be posted in an earlier post by another member). By posting this link, I am not necessarily endorsing this "trial" - I am simply posting the link (no more, no less):

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

 

[RaZaH]

Man...maybe its my mood today but I am kind of annoyed by this .
If there is some sort of noise that could help with T why not just make it available , registering at your site and filling out a form or something?
Surely , that would provide you with enough test subjects and if it works, word of mouth would surely help you raise the capital to make that Ipad app.

 

[kirsten puls]

Dear Zimichael,

http://turnofftinnitus.com/

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

All the best,
Kirsten

 

[kirsten puls]

Dear HaZaZar and attheedgeofscience,

I know what you suggest would of course be great - it's the natural thing to think of. But Ian looked into this and it's unlawful.

The rules for running a clinical trial with an investigational medical device are pretty much the same in the USA as in Australia (we'll be applying for reg. in the US first if the trial is ever fund and succesful.

See device regulation guidance on the FDA site.

An institutional review board must approve the study.

In Australia, for instance it is illegal to run human research without either TGA or HREC approval.

Even a pilot is a human research.

It's a similar regime in the USA.

The notion of sending tinaway out to 100 people and seeing what happens is against the regulatory framework.

Ian had expert advice on this from an experienced regulatory person.

Mobile phone apps like tinaway are regulated as medical devices, even though it will be over the counter.

From a practical standpoint. tinAway isn't like other products you might be thinking of - you need to have a training session to learn how to locate your suppressor sound by fine tuning different sound parameters (i.e. carrier frequency, envelope frequency, latency and other sound parameters).

I hope that helps.
Kirsten

 

[Steve]

you need to have a training session to learn how to locate your suppressor sound by fine tuning different sound parameters (i.e. carrier frequency, envelope frequency, latency and other sound parameters).

I think @RaZaH may not need the training, he could probably show you a thing or two about sound.

The trial app doesn't need to be medical at all, you just need to prove your concept; conduct a trial to prove your theory is sound and could potentially have a medical application.

It's a sound generator at the end of the day. You may have licensed the commercial product as a medical app but that does not stop you using your sound generator to see if it has an effect on people. You are testing a sound-related theory, not a drug. Lady gaga doesn't have to ask permission to play her albums to people (though maybe she should).

Why have you registered as a medical device when you have no proof that it will function any different to an iPod?

 

[kirsten puls]

Dear atheedgeofscience,

tinAway does not work like any of the products you mention and it does not aim to reduce symptoms. It aims to get rid of them - i.e., turn the tinnitus off, completely, permanently. It is not aiming to do the same thing as either Oasis or ACRN - it works according to a new model the Dr Dixon discovered (2013) and the sounds it produces are different also, in the following ways:

How is tinAway different to sound therapy or masking?

Sound therapy using masking aims to provide temporary relief from tinnitus but replaces one noise for another. tinAway is different in three ways:

1. tinAway is based upon the ASA model of tinnitus; a model of why tinnitus happens and why remission is rare in adults. So tinAway is aiming at treating and curing tinnitus.

2. The tinAway sound aims to suppress the tinnitus during each session. Suppression is when the user no longer hears the tinnitus. Suppression can occur when the suppression signal is very quiet – maybe near threshold.

Temporary suppression, where you hear NO tinnitus can be caused by certain sort of sounds (work done about 10 years ago by Franz's group, and Ian was involved in this). But no one could explain how this happened or figure out how to make it permanent. That's what the last 10 years of research have been about. Now we think we do how suppression might happen and how it might be made permanent. We just need to test it to see if it works.

How does tinAway generate the tinnitus suppressor sound paradigms?

The tinAway device does not rely upon a single fixed sound signal.

tinAway therapy will not seek to match the frequency of your tinnitus. Instead, with tinAway we'll be seeking a complex multi-dimensional (i.e. carrier frequency, envelope frequency, latency and other sound parameters) sound signal that best suppresses your tinnitus at that time.

tinAway employs an advanced algorithm and user interface that will allow the user to progress towards the suppression signal relatively quickly and easily. tinAway will also allow the user to recall information from previous sessions – so that it should become easier over time to find the sound which the user finds temporarily supresses their tinnitus.

With tinAway, the pitch of the sound may not be as important as other parameters - for instance, pulsatility or the nature of the 'sound envelope'.

Would you like to know the theory behind how suppression can occur? It's quite involved but I can put it in a separate post if you like. The thing is the research is very new (2013) and most had dropped the idea of suppression for the reasons I mentioned, but Ian keep at it because 'it frustrated the daylights out of him' as he put it. He hasn't published the results because he wanted data - the sort we're now trying to generate and the sort investors such as yourself also ask for. Also for IP reasons. The patent people also want data. This is a catch22. The only way out of it Ian could see was crowdfunding. Once we can test it, and provided it does actually stop (NOT just reduce) tinnitus, then things will be much more straightforward.

I hope that helps,
Kirsten.

 

[attheedgeofscience]

But Ian looked into this and it's unlawful.

Dr. Puls, as a biologist, you are no doubt aware of one of the pioneers in the field of vaccines: Jonas Salk. As you may or may not know (it is not common knowledge), Mr. Salk tested the first polio vaccine on his own family (no clinical trial beforehand back then!).

And likewise, I'd like to ask (without expecting an answer): if you drive a car, do you always stick to the speed limit? Have you never ever driven just 5 kph above the speed limit somewhere? Anywhere? Basically, who cares if it is unlawful. Just break the law then...

My assumption is that you probably have tested the device (I would have!) but you are not willing to publicly state that because it would be unlawful. That's my guess. But it would be nice to know. Especially for potential investors...

 

[jazz]

He hasn't published the results because he wanted data - the sort we're now trying to generate and the sort investors such as yourself also ask for. Also for IP reasons. The patent people also want data. This is a catch22. The only way out of it Ian could see was crowdfunding. Once we can test it, and provided it does actually stop (NOT just reduce) tinnitus, then things will be much more straightforward.

I'm not trying to be rude here, but every purveyor of snake oil can make the same claims.

Just saying....

Even big pharma would not be so audacious....

My goodness!

 

[cullenbohannon]

I would like to hear the theory .

Dear atheedgeofscience,

tinAway does not work like any of the products you mention and it does not aim to reduce symptoms. It aims to get rid of them - i.e., turn the tinnitus off, completely, permanently. It is not aiming to do the same thing as either Oasis or ACRN - it works according to a new model the Dr Dixon discovered (2013) and the sounds it produces are different also, in the following ways:

How is tinAway different to sound therapy or masking?

Sound therapy using masking aims to provide temporary relief from tinnitus but replaces one noise for another. tinAway is different in three ways:

1. tinAway is based upon the ASA model of tinnitus; a model of why tinnitus happens and why remission is rare in adults. So tinAway is aiming at treating and curing tinnitus.

2. The tinAway sound aims to suppress the tinnitus during each session. Suppression is when the user no longer hears the tinnitus. Suppression can occur when the suppression signal is very quiet – maybe near threshold.

Temporary suppression, where you hear NO tinnitus can be caused by certain sort of sounds (work done about 10 years ago by Franz's group, and Ian was involved in this). But no one could explain how this happened or figure out how to make it permanent. That's what the last 10 years of research have been about. Now we think we do how suppression might happen and how it might be made permanent. We just need to test it to see if it works.

How does tinAway generate the tinnitus suppressor sound paradigms?

The tinAway device does not rely upon a single fixed sound signal.

tinAway therapy will not seek to match the frequency of your tinnitus. Instead, with tinAway we'll be seeking a complex multi-dimensional (i.e. carrier frequency, envelope frequency, latency and other sound parameters) sound signal that best suppresses your tinnitus at that time.

tinAway employs an advanced algorithm and user interface that will allow the user to progress towards the suppression signal relatively quickly and easily. tinAway will also allow the user to recall information from previous sessions – so that it should become easier over time to find the sound which the user finds temporarily supresses their tinnitus.

With tinAway, the pitch of the sound may not be as important as other parameters - for instance, pulsatility or the nature of the 'sound envelope'.

Would you like to know the theory behind how suppression can occur? It's quite involved but I can put it in a separate post if you like. The thing is the research is very new (2013) and most had dropped the idea of suppression for the reasons I mentioned, but Ian keep at it because 'it frustrated the daylights out of him' as he put it. He hasn't published the results because he wanted data - the sort we're now trying to generate and the sort investors such as yourself also ask for. Also for IP reasons. The patent people also want data. This is a catch22. The only way out of it Ian could see was crowdfunding. Once we can test it, and provided it does actually stop (NOT just reduce) tinnitus, then things will be much more straightforward.

I hope that helps,
Kirsten.

 

[jazz]

I would like to hear the theory .

And I'd like to see the data behind it.

 

[attheedgeofscience]

tinAway employs an advanced algorithm and user interface that will allow the user to progress towards the suppression signal relatively quickly and easily. tinAway will also allow the user to recall information from previous sessions – so that it should become easier over time to find the sound which the user finds temporarily supresses their tinnitus.

Dr. Puls - how do you know all this if you have not tested the device at all...?

Quite impressive (sarcasm intended!)...

However, I fully understand the delicacy of what you can - and what you cannot - state in a public forum in a case such as yours. Not easy.

Would you like to know the theory behind how suppression can occur?

Well yes - but I am not sure I would understand it! And also, I would be surprised if you would be willing to publish unique knowledge on curing a condition which has plagued mankind since... well, since, a very long time. I believe tinnitus comes from the latin word "tiniere" - so indeed, it must have been around for some time...!

Dr. Puls - thank you for your time (no sarcasm intended). When you are ready to talk "business" (= hard facts), let me know!

 

[RaZaH]

Send me the app and instructions for use . If it works I will invest $10.000 .
There is no better way to get all of us to invest , hell I would invest more if it worked.
I am being serious.

Yes, we are a tough crowd and I do not mean to be rude , rest assured , if you can convince any of us to invest you got your "sales pitch" locked down

 

[kirsten puls]

Dear all,

What the invention is based on is a set of observations, experiments and theory of previous groups. Putting all the different pieces together to build a theory for how tinnitus might happen is what Ian did.
That certain sounds can produce tinnitus suppression has been shown (eg Franz & Offut 2003) and Ian was involved in that as an engineer. tinAway is designed with the aim of producing sounds capable of suppression.

The ASA model of hearing (there is lit. on this - I'll ask Ian which he would recommend or look in Pubmed) is about how the brain creates auditory objects. Tinnitus occurs, Ian thinks, when irrelevant firing of auditory neurons is read as if it's a sound and

 

[Markku]

That certain sounds can produce tinnitus suppression has been shown (eg Franz & Offut 2003)

Nothing new here.

I attached the study in question. I believe some people will experience RI with products such as HushTinnitus etc, but it's indeed temporary and some don't get any benefit at all...

Based on what you have told us so far, I think there's not enough evidence to claim that tinAway is anything more but a glorified masking tool.

You can claim whatever you wish, but without showing us any evidence, why would people believe what you say when lots of companies have been around the block so many times before offering audio therapies without any appreciable success?

Hope I'm wrong. I think some of us tinnitus sufferers are just tired of hearing about "one more audio therapy", especially when the claims made are so extravagant (i.e. "It aims to get rid of them - i.e., turn the tinnitus off, completely, permanently.")

 

[kirsten puls]

Sorry, pushed reply accidentally. I have a child lying on my lap! Anyway this irrelevant neural code is mismatched to an auditory object - a pure tone, for instance.

Suppression, Ian thinks, occurs when the external sound from a device is tuned so that it generates neural code which is a better match for the auditory object than the tinnitus neural code. The mismatch is corrected and the tinnitus goes. But it comes back, as other groups found. Ian wondered if repeating the mismatch correction would lead to calming the EP path over time and render suppression permanent. This is the idea he wants to test. Repeated suppression to me sounds like something to try, even if you didn't have a theory for it, but everyone is free to have their own opinion. I think the device is worth testing - the potential benefits if it did happen to work are enormous. Also we'd know if that sort of approach is effective or not.

To the reg. questions, it's the FDA who decides if a device is medical or not. If we hand the app out like radios, but without knowing how to use it to generate suppressor sounds it'd be no help to anyone. The minute you try to give instruction, you risk the law. I imagine it's theoretically possible people might even make their tinnitus worse playing around.

I have to get going now - maybe I'll reserve some time say this evening my time, morning your to answer some more.

All the best
Kirsten

 

[kirsten puls]

Ok before I go,

Markku, I'm not an expert on masking but I understood it to be different to suppression - in masking, the tinnitus is drowned out, in suppression, the tinnitus sound isn't 'heard' anymore ' Of this number, 22 (64.7%) experienced suppression'. That's what we want to do and make permanent.

 

[kirsten puls]

Dear RaZaH,
I would have to get Ian to reply to what you suggest. I'm pretty sure he wants to go by the book though. I can understand how frustrating it is - he's frustrated too. He might be on later today so I'll ask him to might reply.
All the best
Kirsten

 

[Martin69]

Bla bla bla.
Markku explained it all.

 

[attheedgeofscience]

Dear RaZaH,
I would have to get Ian to reply to what you suggest. I'm pretty sure he wants to go by the book though. I can understand how frustrating it is - he's frustrated too. He might be on later today so I'll ask him to might reply.
All the best
Kirsten

So far, I have travelled a good 40,000 km for all of my experimental tinnitus treatments - that's an entire trip around the Earth. And I nearly ended up in a coffin for my 2nd stem cell treatment in China. Later on this year, experimental non-invasive brain surgery is on the menu. Not to mention several other initiatives I have been involved in... So believe me, if you need a human guinea pig for something as harmless as playing music into my ears, then you have yourself a candidate. And if it works, I am pretty sure I know "some people" who would be interested in funding your initiative. But the question is just that: does it work...?

Dr. Puls, have a good day...

 

[kirsten puls]

Dear RaZaH,
I would have to get Ian to reply to what you suggest. I'm pretty sure he wants to go by the book though. I can understand how frustrating it is - he's frustrated too. He might be on later today so I'll ask him to might reply.
All the best
Kirsten

 

[kirsten puls]

Dear Everyone,
Ian suggests giving you an FAQ which we can send as a file or put in a post. We hope it will be some help. If there's anything else I'll try to keep replying to new questions but please keep in mind there's only 1 of me (and atm. I have 4 sick kids on my hands).
Dear attheedgeofscience, I was horrified to read what you've been through. It certainly helps me understand better the incredible frustration (among other emotions) you and many others must feel. I got into science myself b/c I wanted to cure my grandma's RH which crippled her and I was angry and frustrated there was nothing to cure it (I didn't cure it, of course).
Anyway, I can't tell you if tinAway will work - but when and if they can ever test it, we'll certainly let you know the results, good or bad.
Sincerely,
Kirsten.

 

[Raindance74]

Dear RaZaH,
I would have to get Ian to reply to what you suggest. I'm pretty sure he wants to go by the book though. I can understand how frustrating it is - he's frustrated too. He might be on later today so I'll ask him to might reply.
All the best
Kirsten

Kirsten, I think the best person you should talk to is Dr. Thomas Coleman. He is a leading expert on tinnitus research and has written extensive books on the issue. Just Google his name and I'm sure he can help you find lots of people with cash to invest in Tinaway.

 

[kirsten puls]

Dear Raindance74,
That's very helpful, thank you very much! I'll look him up now!
Thanks again,
Kirsten.

 

[kirsten puls]

Ah. Joke I didn't get. Didn't know the name, feel silly.

 

[RaZaH]

Kirsten, I think the best person you should talk to is Dr. Thomas Coleman. He is a leading expert on tinnitus research and has written extensive books on the issue. Just Google his name and I'm sure he can help you find lots of people with cash to invest in Tinaway.

That cracked me up !! hahahah !

 

[Zimichael]

Ha, ha... This thread is not one I am taking too seriously, as stuff like this sort of...well make up your own mind:

"Anyway, I can't tell you if tinAway will work - but when and if they can ever test it, we'll certainly let you know the results, good or bad."

I mean here we have this huge mega-thread on Retigabine and so forth and these people can't even invite a bunch of folks from here to try their "killer app." and give feedback in a thread???????????????????
- Voluntarily.
- Given to us a s "Gift" (to avoid the IRS ...Ha ha).
- To get free guinea pigs.
- To ummmmmmmmmmmm..."Like, you know, try it out".

Maybe I'm feeling sarky from lack of sleep over past week (Benzo taper) but "Good Grief!"

As usual people here do a great job of slicing and dicing 'reality'...with ATEOS bringing in his usual "deep data $ and all" insight comments.

Zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz.... Oh..... Zzzzzimichael.