Potential Scam, Snake Oil: TinAway

[tomytl]

just found this
http://www.heraldsun.com.au/leader/...030901145?nk=1ccf4471508ba7e5a9da178bdafa24a2

serious or one of the next noise generators?

 

[t-man]

Another gimmick.

 

[James White]

seems like residual inhibition...

 

[Ray Seddon]

Hmmmm... agree T-Man. I'll stick with my little ole mp3 player methinks - seems like a fancy masker to me... but let's hope we're wrong...

 

[lapidus]

"cure"

Okay, good luck with that

 

[kirsten puls]

Dear Tomytl,

I just saw your post, sorry to not reply sooner. tinAway IS real - I'm working with the inventors, who are a team of biomedical and software engineers. During his PhD on tinnitus, Dr. Dixon (one of the inventors) arrived at a new model for how tinnitus arises. The potential cure is based on this - it's an iPad app which generates sounds designed for suppression. According to the model, repeated suppression should eventually dampen the overactive extralemniscal pathway and break the feedback loop responsible for tinnitus.

The simplest is if you visit the website to learn more. At the moment a prototype is ready for a clinical trial. The problem is the inventors don't have the funds to run it. We're reaching out to the public at the moment in an attempt to get tinAway tested so we can see if we really do have the answer. (My sister has tinnitus and so I hope for her sake and the sake of many others that we can fund the trial.)

Oh - the site won't let me include the link - I'll include it in the following post.

Sincerely,

Dr. Kirsten Puls.

P.S., Are you in Switzerland? I worked in Basel for 13 years!

 

[kirsten puls]

We have a very detailed site with general tinnitus info and which gives the in depth information on the new model, as well as reviewing present treatments (turnofftinnitus). (The site still won't let me put links in)

If you would like to find out more about the clinical trial and campaign:

look for tinAway on Indiegogo

I hope this provides some answers.

 

[Robb]

Don't wast anymore time on this garbage

Why?

- Many companies try to be innovative with a sound therapy read try to cash in so does Tinaway
- Continous exposure to noise is not beneficial to ear
- Kirsten represent a company that claims to fully make T disappear, by the help of their technology.
This is complete wishful thinking

Being harsh is necessary sometimes to punish those who wish to exploit the weak

I encourage sound therapy businesses to strongly back up their claims of effectiveness, In case they can I will buy

 

[Grace]

What about people with hissing and static type T or 3 or 6 different sounds and not all tonal. This is bs and its NOT gonna cure it just sayin...

 

[tomytl]

Dear Tomytl,

I just saw your post, sorry to not reply sooner. tinAway IS real - I'm working with the inventors, who are a team of biomedical and software engineers. During his PhD on tinnitus, Dr. Dixon (one of the inventors) arrived at a new model for how tinnitus arises. The potential cure is based on this - it's an iPad app which generates sounds designed for suppression. According to the model, repeated suppression should eventually dampen the overactive extralemniscal pathway and break the feedback loop responsible for tinnitus.

The simplest is if you visit the website to learn more. At the moment a prototype is ready for a clinical trial. The problem is the inventors don't have the funds to run it. We're reaching out to the public at the moment in an attempt to get tinAway tested so we can see if we really do have the answer. (My sister has tinnitus and so I hope for her sake and the sake of many others that we can fund the trial.)

Oh - the site won't let me include the link - I'll include it in the following post.

Sincerely,

Dr. Kirsten Puls.

P.S., Are you in Switzerland? I worked in Basel for 13 years!

Hi Kirsten,
thanks for explaining. So we hope they can get enough money to run the trial.
Was there a "pre-trial" with a smaller groups?
Why is there a need for FDA approval?

Greets
Tom

 

[t-man]

Confirmed gimmick.

 

[kirsten puls]

Hi Tom,
No problem. This trial we are trial to fund will be the first one. However trials in suppression have been done before back in the 90s with small groups of patients. These researchers found that they could generate sounds that could produce suppression, but the problem was it wasn't permanent. I'll get to that point below.

To Robb:
I don't claim tinAway will work, but the science makes sense (I have a PhD in med. biol.). I understand your skepticism. It's true there are heaps of sort of glorified masking devices out there. But this is different because the aim hear is not masking. It's suppression.

That means that the trial results will be pretty clear - either it works, or it doesn't, no half way house. If it doesn't work, Ian will go back to the drawing board. If the trial does work, the device will be registered with the FDA.

(Of course if we can't raise enough for a trial there won't be one and that'll be the end of it. We won't ever know if it would have worked).

Maybe I'd better explain a bit more:

About 10 years ago, scientists discovered they were able to suppress tinnitus temporarily - but they didn't understand why and they didn't have the technology to make a device which people could use to make these sounds themselves. Dr.Dixon was involved in this research and found it terribly frustrating that the suppression was only temporary (he was frustrated as a scientist, you know, wanting to know why, or in this case, why not. After that he worked at Monash University (Australia) on the problem. Took him years!

What happens in tinnitus is that the brain mistakes irrelevant firing of auditory nerves as if they were generated by a real sound. According to the new model (the Auditory Scene Analysis model of chronic tinnitus), the brain attempts to match the neural firing pattern with an 'auditory object' from it's memory bank. There is no match of course, so it presents to perception the best match - which could be any sort of sound in theory. But the brain recognises there's a mistake, and part of the fight-or-flight response (the extralemniscal pathway) is activated which perpetuates the tinnitus.

What suppression does is to find a sound that matches the random firing well enough for the brain to decide the mistake has been corrected. It's not permanent, we think because the extralemniscal path is still elevated. It's by repeated mismatch correction we hope to calm the system.

Grace, regarding sounds:

tinAway is nothing to do with matching the frequency of your tinnitus. Instead, 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. It doesn't matter what sound you 'hear', you modify the sound parameters until you reach the sound that works for your particular sound.

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

Regarding loudness:

As for loudness, they found in the previous research I mentioned that suppression can occur when the suppression signal is very quiet – maybe near threshold; so suppression sounds are not expected to be bothersome.

 

[Grace]

I totally respect this company for trying, afterall T needs to be treated somehow but i guess im just not quite understanding. Some say when they listen to a sound similar to there T that it makes there T go away for a few seconds --- which is residual inhibiton? But for those that cant quite match there T-- it seems this wouldnt work for them. Again maybe im not understanding it--- is this a T matching tone device to suppress T and eventually doing it so much your saying will cure T? Sounds like mute button if so...

 

[kirsten puls]

Hi Tom,
Sorry, I forgot to answer the bit about the FDA. When you have a device whose purpose is medical, you must register it, there's no choice, and you have to play by the FDA rules (which are the law of course). And you can't just try it on people outside of a clinical trial setting. My sister wanted to volunteer, for instance. But the trial, if it happens, will be run by independent clinicians in a specialised lab who recruit patients from audiologists. She would/will have to go through that route.

I could also ask Ian to join the thread to answer questions if you like, since I'm new to the field (I started out as a molecular immunologist) - he can give more in depth answers about how the trial would be run and why, and also about the mechanisms of tinnitus.

Kind regards,
Kirsten.

 

[kirsten puls]

Hi Grace,
It is very confusing. It took me ages to get my head around what was supposed to going on. Can I get Ian (Dr Dixon to answer your question? He's the expert.

 

[Andersss]

Kirsten,

I just watched your video on Indiegogo. I think it looks very promising, and the guys actually seems like legit science people.
Thanks for taking the time to explain about the concept here.
I will def. support you.
Please get Dixon on the forum, we would like as much detailed info as possible.
Thank you!

 

[kirsten puls]

Thank you so much, Andersss!

Ian is in the car on the way to the hospital, but when he's back he'll jump online.

Grace, tinAway is not about trying to match the tinnitus sound, but it makes a sound which produces a pattern which closely enough matches the neural code of the irrelevant firing. It's much easier to explain with diagrams, so if you have a look at the site we made to explain it that might help you.
turnofftinnitus is the site name (still can't send links).

Residual inhibition is a residual reduction of tinnitus perceived loudness after masking. But tinAway doesn't mask tinnitus - should stop it. A first, temporarily, and then hopefully this will become permanent. We can do this now because we finally have a model for how it happens.

It is possible to get complete remission from tinnitus - it happens in kids! When kids mature, their EP pathway is dampened naturally as part of the process and kids with tinnitus recover. We're trying to mimic this.

We don't know if it will work, but we think we should try. But even in the worst case, we'll at least answer the question, so the science can move forward.

 

[kirsten puls]

Dear t-man,

If people are skeptical - and they should be! - the only way to find out if they are right that it's all a sham is to test it. It will be pretty obvious if tinAway doesn't work because we're not aiming to reduce tinnitus or soothe symptoms - but get rid of it - so you hear zero tinnitus sound.

tinAway might not work - but then again, it might! And that would be great, so let's all see.

 

[Grace]

Thank you so much, Andersss!

Ian is in the car on the way to the hospital, but when he's back he'll jump online.

Grace, tinAway is not about trying to match the tinnitus sound, but it makes a sound which produces a pattern which closely enough matches the neural code of the irrelevant firing. It's much easier to explain with diagrams, so if you have a look at the site we made to explain it that might help you.
turnofftinnitus is the site name (still can't send links).

Residual inhibition is a residual reduction of tinnitus perceived loudness after masking. But tinAway doesn't mask tinnitus - should stop it. A first, temporarily, and then hopefully this will become permanent. We can do this now because we finally have a model for how it happens.

It is possible to get complete remission from tinnitus - it happens in kids! When kids mature, their EP pathway is dampened naturally as part of the process and kids with tinnitus recover. We're trying to mimic this.

We don't know if it will work, but we think we should try. But even in the worst case, we'll at least answer the question, so the science can move forward.

Okay im understanding it better now, thanks for the explanation! but i wish you guys the best of luck... If this would work this would probably be an actual cure unlike drug therapy where most likely having to take a drug everyday to supress the T. either way i think us with T arent too picky when it comes to treating it, so what ever works best the better but ofcorse i hope this works too ill take a look on the site to understand it better, thanks!

 

[kirsten puls]

My pleasure. Absolutely - whatever works!

 

[Raindance74]

I wouldn't get too excited about this Tinaway product. Every six months a sound device comes on the market with pretty much the same claim, that they can suppress the tinnitus signal by disrupting the overly excited neurons within the auitory cortex region of the brain (which is where tinnitus is produced). If anything the objective is to target desperate people with money to burn and if it works its most likley a placebo as tinnitus is such a subjetive condition. If it doesn't work they can always say "Well, everyones different... nothing works for everyone." or some bullshit like that. Chances are this company will be long gone and replaced by someone else doing the same thing next year. Until they find a way to actually regenerate lost cells within the cochlea your best bet is to buy an mp3 player with masking sounds and have a nice glass of rosé.

 

[Ian Dixon]

Hello everyone on this forum at Tinnitus Talk, and thanks for the invitation to join.
Sorry I am late on today, my father is in hospital and I was visiting him.
Kirsten has given some introduction to us, and I have joined in (thankyou for the invite) to answer your questions and concerns.
We are 100% open to discussion and dialog, and eventually the clinical trial will show if my Phd thesis was useful or not.
Our present mission is to scientifically (and independently) show if regular and frequent suppression cures tinnitus in a good percentage of the people who use it. The ASA model of chronic tinnitus predicts this, but even I want solid data to show us the answer.
Open to questions. Thanks
Ian

 

[Miss lavender]

Hi Ian, I am from Melbourne also.
Is there any chance that there will be a clinical trial of some sort in Melbourne?

 

[Ian Dixon]

Hello again.
Maybe I can take a bit of time (while most of you are sleeping) to address some of the concerns from the thread; at least it will generate some discussion-points.

Firstly, after around 11 years of research in this field, I would also be very skeptical about a new treatment (and especially cure) for tinnitus - unless the underlying science made sense to me. My literature review was exhaustive - and I found no evidence of a treatment that actually turned off the tinnitus. So, after many decades the field is replete with unsubstantiated and anecdotal tablets etc that have no basis in science. That said, there are some good models and associated treatments (TRT is a prominent example that has been subject to extensive scientific review) to help people cope with their tinnitus. But my interest was how to eliminate the noise itself.

The other thing is that usually the development of a good and proper treatment follows having an understanding of what is causing the problem. It is possible to get treatments by a hit-and-miss approach, but unlikely. In drug development we call this understanding "mechanism of action" and "disease mechanism". In my view, understanding "why" chronic tinnitus arises and is maintained is the key to treatment. The "why" has to be very specific - not enough to say excess auditory neural activity.

A further issue is where does tinnitus "come from" ? Many years ago there was a notion of peripheral tinnitus and central tinnitus; and that maybe peripheral tinnitus became centralized over time. There are a number of reasons to believe that chronic tinnitus is actually of central origin (i.e. in the brain and not the cochlea). Briefly, these are (i) some people hear their tinnitus as complex sounds (e.g. notes of a song) (ii) cutting the nerve between the cochlea and the brain doesn't solve the problem and (iii) many people with profound damage of the inner ear (e.g. inner and outer hair cells as determined at post mortum) do not have tinnitus, and some people with tinnitus have almost normal hearing (but often hyperacusis).

In an interview I was asked - was there a eureka-moment in my research. Yes, was the answer. After many years of dead-ends, I went back to the literature (again) and found some publications (some from Germany) in good journals about children with tinnitus and how common it was - and how remission (i.e the tinnitus goes from being with them mostly to ceases) is common i.e. the norm. In adults, remission from chronic tinnitus is very rare. That threw me into looking at what was happening with the children and why did they have chronic tinnitus that ceased. tinaway aims to replicate what happens with the children and why their chronic tinnitus ceases.

I believe that good science eventually answers questions. As an example, Dr Barry Marshall was awarded a Nobel Prize for showing that an odd bacteria (h-pylori) and not excess acid caused stomach ulcers and that a triple antibiotic was the "proper" treatment for stomach ulcers (not the traditional antacids). Barry actually proved his point by swallowing h-pylori, infecting his stomach, suffering stomach ulcers and then treating himself with antibiotics and curing his stomach ulcer without antacids.

Hopefully I can answer any other questions you might have.

Regards
Ian

 

[Ian Dixon]

Hello. Thanks for your question.
Regarding location of the clinical trial. At this stage the clinical trial is likely to be in Melbourne (maybe at Monash Alfred) or in the USA. Because we are a company we must pay the insurance for the trial and also all trial costs and also the costs of the Human Research Ethics Committee to approve and monitor the trial.
Regards
Ian

 

[Grace]

I wouldn't get too excited about this Tinaway product. Every six months a sound device comes on the market with pretty much the same claim, that they can suppress the tinnitus signal by disrupting the overly excited neurons within the auitory cortex region of the brain (which is where tinnitus is produced). If anything the objective is to target desperate people with money to burn and if it works its most likley a placebo as tinnitus is such a subjetive condition. If it doesn't work they can always say "Well, everyones different... nothing works for everyone." or some bullshit like that. Chances are this company will be long gone and replaced by someone else doing the same thing next year. Until they find a way to actually regenerate lost cells within the cochlea your best bet is to buy an mp3 player with masking sounds and have a nice glass of rosé.

I dont think were gonna have to wait to "regenerate hair cells", to cure or treat T itself. To restore hearing, yes but Tinnitus is mostly a symptom of hearing loss and were lacking something in our brain to normalize the neurons and keep them from misfiring-- which is what autifony is aiming to do and other drug companies will start up the competition like am102 in preclinical-- all for chronic T. They dont even know if we could grow haircells back if that would even cure T.. Sounds right but you would think the neurons would still be stuck(not permanent) therefore we need a drug to interact-- pottasium channel kv3 directly targetting the channels related to tinnitus to intervene the stuck position to relaxed calm state= less T or no T. (a more or less summary of what @benryu stated) I respect what Tinaways trying to do, basically the same as autifony but instead of drug form its through sound suppresion and yeah theres alot of devices out there that fail but who knows, one of these times one might work or maybe a combination of drug/and suppression in the future its too hard to tell yet, but like i said noone with T is picky, if it works it works!!!

 

[kirsten puls]

Dear Raindance74,

It's true that there's a huge placebo effect in tinnitus trials. But that's a reduction in tinnitus symptoms which is not what tinAway is designed to do - the aim here is to STOP it COMPLETELY and you just can't fake that, or get it by placebo effect (at least to my knowledge). This is called suppression and has been shown to be possible in the part. The problem was it was temporary. We want to make it permanent.

The therapies that you mention don't work in the same way - what we are trying to do is different. We are not trying to dampen overexcitation by influencing those pathways directly. We are trying to undo the underlying mistake being continuously made by the brain. No other group is trying this, because this model is new. We've tried to explain the science in detail on a website: turnofftinnitus.

I know it sounds to good to be true, but there is good science behind it. Lots of cures seemed to good to be true at some point.

We are trying to test a new treatment (and scientific model) and see if it really can work.

Kind regards,
Dr. Kirsten Puls

 

[jazz]

@Ian Dixon @kirsten puls

Hello!

I hope you will answer this very important question:

Where has the research on your proposed intervention been published? I just did a PubMed search on Dr. Dixon and could not find anything with his name and tinnitus. Nor could I find any publications listing his name and hearing. Being published in the scientific literature is a necessary prerequisite to any type of proposed medical intervention. Research for medical interventions may certainly begin--but surely cannot end--with a dissertation.

I did find Dr. Dixon's thesis; but the thesis does not prove his theory will reduce--let alone cure--tinnitus.

And are their other interested parties willing to fund your project? Only crowdfunding? No grants from anyone else? No interest from the business or venture capital community?

For anyone interested in Dr. Dixons thesis, here's a link to it:

http://arrow.monash.edu.au/vital/access/manager/Repository/monash:120356

BTW, I do hope I am wrong and there is published literature in peer-reviewed journals. If so, please enlighten us.

Below is a screenshot of my search. Again, I hope I've missed something.

 

[Zimichael]

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

 

[attheedgeofscience]

The potential cure is based on this - it's an iPad app which generates sounds designed for suppression

Dr. Puls, if indeed this is an iPad application, why is there a need to have funding to test if it works? You could just arrange a local gathering of tinnitus volunteers and find out if it works (on a small scale)? Have you already done this? [I realize you have sort of answered this in another post; see next quote].

My sister wanted to volunteer, for instance.

There is nothing to prevent her from doing so. Nobody will ever know if she took part in a (harmless) medical experiment. If the "treatment" consists purely of sound, then "you" - the medical provider - is doing nothing more than providing the "patient" with sound therapy (which is freely available all over the Internet). This would be equivalent to you lending your sister a CD with classical music. I don't believe anyone ever got arrested for doing so (at least not from a medical perspective).

and you have to play by the FDA rules

I did not know that the FDA governed the rules of local clinical trials in eg. Australia or the UK. Or Denmark for that matter...

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Dr. Puls, the topic of treating tinnitus using sound therapy (eg. Neuromonics' flagship model Oasis and the more advanced(?)CRN-modulation) has already been around for a while (as other posters have mentioned). The results are "so-so" (at best). I appreciate you taking the time to join the forum, but I find it hard to believe that the results from your device should somehow be(come) revolutionary ie. what makes your research "so special" that others would have missed it? Currently, the combined capital raised by all pharmaceutical companies involved in the field of otology therapies would easily reach the ½-billion dollar mark (see finanial overview in the attachment which I have compiled). If there was a simple and cost effective therapy - not to mention "side-effectsless" - why would anyone bother to spend millions on pharma? So, yes, I am (also) skeptical, but I would also hate to see good potential wasted. As it happens, I am fairly well connected in the start-ups field. My Father is based in Geneva and is investor and mentor in a business that secures funding for start-ups. The approach is two fold: any successful applicant will automatically be provided start-up capital and free office space for 3 months. Applicants will also be given the chance to present their business ideas in front of big sponsors in order to secure further funding. They focus on pretty much anything which is IT related (ie. Internet commerce, mobile phone technology, software, GPS, iPhone apps, etc.). They do not specifically focus on medical technologies (far from), but they have had previous applicants who had developed iPhone apps for such things as displaying heart rate and possibly other patient stats. I am not going to go into too much detail on a public forum. But... I am sort of curious as to how you believe this application of yours is a) going to work, and b) why it is not already been tested informally on volunteers (ie. outside of a clinical trial)? Without knowledge of such basic questions, why would anyone want to invest anything in a company? As a financial investor myself, I don't care about interesting research; I care about results! And preferably the tangible kind which can be read on a profit/loss statement.

I appreciate your colleague(?) Dr. Dixon taking the time also to respond to a couple of posts. I agree that tinnitus is underestimated in children. Most ENTs would describe tinnitus in children as "very rare". Tinnitus in children is neither "very rare" nor "rare", but probably best described as "uncommon". However, I am not sure that tinnitus is necessarily something that goes away when passing into adulthood (but I am not saying it does not in some cases). But even if it does go away, then I am not sure I see the connection between your device and the disappearance of tinnitus in children (but of course this is your "business secret", I guess).