MuteButton

[Drone Draper]

Me too. Wondering if there'll be waiting lists.

Fuuuuuu Not only would you need to wait for the thing to be released, but then you have to be on a waiting list, too?

I think maybe the price will curtail demand to the point where it won't be an issue... but then, if it's as effective as the trials, it should be offered to absolutely everyone who has this wretched disease, regardless of financial standing.

 

[Agrajag364]

You're confusing the trials. The first link you posted was neither TENT-A1 (326 patients) or TENT-A2 (192 patients). That was a small pilot study done just before the original MuteButton was launched.

There were 3 arms in TENT-A1 (326 patients) that was divided 80% being trialled in Ireland and 20% in Germany. This study has been completed and is in the process of being peer reviewed. We have yet to see the papers.

The TENT-A2 study (192 patients) is still ongoing and should finish the 12 month follow up soon. This study has 4 arms divided by 80:80:16:16.

Here is a link to the recruitment of the study
https://clinicaltrials.gov/ct2/show/NCT03530306

What I found curious is that part of the inclusion criteria for the TENT-A2 is 'tonal' tinnitus, yet Dr. Ross O'Neill stated the tonality/intonality doesn't matter. But atonal tinnitus is not part of the exclusion criteria. However the PI can exclude patients on any other grounds they seem appropriate. This concerns me when studies are made by the developers of the device; how do we know they want to get in as many people with tonal tinnitus and not specifically exclude atonal; just to sell more devices?

Also @Agrajag364, I don't know what these 4 arms consist of or why; but I presume they are confirming the results of the TENT-A1 study and the smaller arms (16) confirming they are the least effective maybe.

Thank you @Paulmanlike. Yes one of the links I posted was just a small early pilot site. The other states it is a proctocol (obviously a protocol for a trial is a description of the study methods and not the actual results) for "TENT-A". Looking at it, and at what you say, it would appear to be a protocol for TENT-A1 specifically.

You linked to the clinical trials page for TENT-A2, thank you. I see it describes all four arms as "active comparator" - I think this means all are expected to have a potential therapeutic effect, in theory. So there's no sham placebo control in TENT A1 or A2 then, in contrast to what was stated in the 2016 paper, which said "These studies will be followed by a Randomised Control Trial to compare this intervention to a sham treatment".

A sham treatment would mean a placebo, some sort of stimulation that is not expected to have any therapeutic effect. I don't know enough about this field to know how significant it is that they have not used a sham arm... so I could be wrong, but it seems like they should have used one and that would make any positive results more meaningful.

Yes I noted that about the PI being able to exclude candidates not "suitable for the study for other reasons not listed above" as well. Again, I'm not sure how normal that is in this field, I thought you were meant to be specific. It seems potentially unscientific because the PI could just exclude people who say they've failed a lot of treatments or something. But maybe it's just intended for exclusion of people with e.g. relevant medical history not covered by the notes.

I'm still really excited about this device but cynical too.

 

[Bob den Hartog]

Fuuuuuu Not only would you need to wait for the thing to be released, but then you have to be on a waiting list, too?

I think maybe the price will curtail demand to the point where it won't be an issue... but then, if it's as effective as the trials, it should be offered to absolutely everyone who has this wretched disease, regardless of financial standing.

Imagine the trials being a representative sample of the tinnitus suffering population, and it benefiting 80%...

 

[Drone Draper]

That. Would. Be. Awesome.

I think I'm a bit too cynical to believe that will take place, but I don't think it will be as low as Desyncra turned out to be.

 

[Jack Straw]

Imagine the trials being a representative sample of the tinnitus suffering population, and it benefiting 80%...

Why wouldn't it be? They had 500+ people in it. That is a huge trial and sample size. I would assume that it would be as close to representative as possible.

 

[Paulmanlike]

Thanks @TimmyC.

Yes that's how I understand it also - the different arms are to determine the best efficacy or reconfirm what was found in the TENT-A1. A limitation on the TENT-A2 study is that they are crossing over after 6 weeks to the next arm, so they won't be entirely sure if the benefits are 'carried over' so to speak.

I guess with my opinions of ACRN - it comes from years of following tinnitus research and treatments. When ACRN came about, it came from Universities and from credible resources, then the trials, then the figures that came out from the company that commercialized the device (Desyncra) with absurd claims 7/10 people benefitted.

Then the testimonials, and the fancy science videos how it worked... you feeling a pattern here? It all amounted to where we are today. To this day it's still offered in the U.K. for £4,500 from a private clinic, and it's nothing more than a handheld machine that's calibrated with headphones and no guarantee it works!

Will Neuromod go this way too? In my opinion, if the results are carried over to patients, I believe it should be evident (that ACRN to me has not been).

As for the evidence being higher this time around, I guess it comes from a lot of speculation (from us) and the results what we know are what they've published so far (extremely small). Even when the results are published, the results will still be extremely small for a medical community to widely accept it as a game changer. I believe it will be a 'time will tell' thing, and it is the reason why I am holding back buying the device on launch.

I just wonder though, say in 6-9 months time, this forum is made up of positive stories regarding Neuromod, that I hope, until that day comes though from this treatment or any other treatment, I will not part with any cash.

 

[kelpiemsp]

What I find interesting is that the outcome measures listed are both of psychological nature (THI & TFI). For some reason I had the impression that they collected actual volume as outcome measure, and that it showed a decrease in volume. Perhaps I'm confused with other trials.

In my trial I was constantly volume matching to dBV FWIW.

Ok @kelpiemsp I hope MuteButton will be efficient on central tinnitus and other causes.

In France we don't have many treatments for eustachian tube diseases... I will make some tests soon to find what my problem is. But I think my eustachian tube stays open most of the time... my ears get blocked, especially in some specific situations... During sports... etc.. I also have TMJ issues...

I have pain to high frequency sounds and sometimes when I speak my right ear is painful.

I think this eustachian tube disorder contributed to the acoustic shock...

@kelpiemsp, now you do not have eustachian tube problems anymore?

@AliceW They are significantly better now that I have my TMJ under control. My TMJ was so swollen it actually plugged my Eustachian Tubes and fluid collected behind both of my ears.

 

[Paulmanlike]

Why wouldn't it be? They had 500+ people in it. That is a huge trial and sample size. I would assume that it would be as close to representative as possible.

Jack makes a good point, Neuromod have performed a huge trial, I think if it was a smaller study then I wouldn't be wasting my time on Neuromod. It's certainly a strength. One criticism I think of though is I am usually suspicious of trials conducted by the developers of a device that are in a business of selling a product. Then again, these guys have submitted it to peer review. There are many reasons to be optimistic about Neuromod and there are many reasons to be pessimistic, so far though, we are looking good.

 

[gorzakus]

Fuuuuuu Not only would you need to wait for the thing to be released, but then you have to be on a waiting list, too?

I think maybe the price will curtail demand to the point where it won't be an issue... but then, if it's as effective as the trials, it should be offered to absolutely everyone who has this wretched disease, regardless of financial standing.

I'm pretty sure there won't be waiting lists for this device, at least not in the first months. I only know about Neuromod because of this forum. My audiologist over here in Belgium has no idea what Neuromod is and the people I know who have tinnitus also have no clue. When you look at Twitter they have 552 followers. Also there is the probably fairly high price for this device, a lot won't even be able to afford it.

 

[Agrajag364]

Why wouldn't it be? They had 500+ people in it. That is a huge trial and sample size. I would assume that it would be as close to representative as possible.

Well for one reason they excluded everyone who'd had tinnitus for more than 5 years, everyone who had tinnitus over 80 dB.

 

[Jack Straw]

Well for one reason they excluded everyone who'd had tinnitus for more than 5 years, everyone who had tinnitus over 80 dB.

They didn't exclude people based on dB noise level like 80 dB, they did the emotional test. I forget what it's called.

I am not sure why they did exclude more than 5 years. It may have to do with the fact that the longer you have tinnitus the less of an effect it may have on your neuroplasticity? But I'm not sure about this.

@kelpiemsp has had tinnitus his whole life and it didn't affect his ability to do these trials so I am hoping how long you have tinnitus doesn't affect the product's efficacy.

 

[GlennS]

Well for one reason they excluded everyone who'd had tinnitus for more than 5 years, everyone who had tinnitus over 80 dB.

I'd be interested in knowing if those filters are also on the current trial. I don't think they should release this to the public until they've done a more universal trial. I mean, if they had reason to believe criteria like this might render the device ineffective, why release it to any and all paying customers? In other words, I need to see positive results from people like me.

 

[DaveFromChicago]

Paulmanlike: My sentiments exactly.

Curiously, Desyncra's first website included clinical trial documentation from allegedly extensive studies conducted in Hungary, Germany, and the UK with such 70% or so success rates. Their revamped website has deleted these three clinical trial PDFs with no further new clinical trial documentation (which presents concerns regarding their original efficacy).

Also, regarding variously newly touted treatments, I am suspicious when I read such vague, noncommittal language such as "my tinnitus was no longer bothersome" or "it was not a major factor in my life anymore." Are patients looking so far over the edge for any degree of relief that their placebo susceptibility replaces any actual sound diminution?

 

[Paulmanlike]

Neuromod are unheard of yet generally... it'll either remain that way or they'll explode. Time will tell, like every other new medical device.

Have you ever heard of BrainsWay, FDA approved to treat OCD? Neither have many medical professionals. That's because they've got very little data of effectiveness.

 

[TimmyC]

Neuromod are unheard of yet generally... it'll either remain that way or they'll explode. Time will tell, like every other new medical device.

Have you ever heard of BrainsWay, FDA approved to treat OCD? Neither have many medical professionals. That's because they've got very little data of effectiveness.

Do you know if Desyncra got a $22m backing like Neuromod? That backing raised some eyebrows when it came out, so I'm curious if people in the medical finance community saw the numbers and went "oh we have to get behind this". Sorry for the ACRN discussion, I guess I'm just hoping this time around there is more of a chance this kind of device will work for us.

 

[Drone Draper]

By the way, I have seen some success stories with ACRN (Desyncra). I think if they didn't charge such an outrageous amount for it, it would've been used more often and maybe had more success stories.

 

[Agrajag364]

They didn't exclude people based on dB noise level like 80 dB, they did the emotional test. I forget what it's called.

I am not sure why they did exclude more than 5 years. It may have to do with the fact that the longer you have tinnitus the less of an effect it may have on your neuroplasticity? But I'm not sure about this.

@kelpiemsp has had tinnitus his whole life and it didn't affect his ability to do these trials so I am hoping how long you have tinnitus doesn't affect the product's efficacy.

I got that from the protocol for the TENT-A study published in the BMJ.

https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

"Eligible patients will be aged 18–70 years at screening; self-report having experienced tinnitus for >3 months and <5 years; score between 28 and 76 points on the Tinnitus Handicap Inventory (THI), have a Minimum Masking Level (MML) measurement between 20 and 80 deci-bels hearing level (dB HL)"

Is @kelpiemsp in the European trial or a different one in the USA based on the same technology? However, I agree that if it worked for him that's a good sign Neuromod might work for people with T that's older than 5 years

 

[TimmyC]

I got that from the protocol for the TENT-A study published in the BMJ.

https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf
https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf
"Eligible patients will be aged 18–70 years at screening; self-report having experienced tinnitus for >3 months and <5 years; score between 28 and 76 points on the Tinnitus Handicap Inventory (THI), have a Minimum Masking Level (MML) measurement between 20 and 80 deci-bels hearing level (dB HL)"

Is @kelpiemsp in the European trial or a different one in the USA based on the same technology? However, I agree that if it worked for him that's a good sign Neuromod might work for people with T that's older than 5 years

@kelpiemsp was in the Minnesota trial (USA). Hubert Lim's study.

 

[Paulmanlike]

TENT-A1 was that you had to have tinnitus > 3months / < 5 years

TENT-A2 is that you had to have tinnitus > 3 months / < 10 years

Just to clarify.

 

[Jack Straw]

I wonder why they included anyone who had tinnitus less than a year. There is a good chance that tinnitus decreases or disappears with anyone who has had it less than a year. I wonder if they took this into account.

 

[Paulmanlike]

Do you know if Desyncra got a $22m backing like Neuromod? That backing raised some eyebrows when it came out, so I'm curious if people in the medical finance community saw the numbers and went "oh we have to get behind this". Sorry for the ACRN discussion, I guess I'm just hoping this time around there is more of a chance this kind of device will work for us.

I know that one company behind it, I think ANM, went bankrupt, and Desyncra took over. They claim on their website that over 4,000 people have been treated and some have reported complete relief of their symptoms (disappearance). However, 4,000 people as I stated before, that in the medical world is very small with a common condition like tinnitus, so it remains an alternative treatment.

I think it worked in some cases but the reason you don't see results is made up of factors such as lack of compliance (you have to wear headphones for 4 hours a day everyday for 16 weeks), the ridiculous cost, and the ease of how it can be copied, having to have a tight criteria for it have chance of success (tonal / <10 kHz tinnitus frequeny)

Companies looking to commercialise treatment realise patients want a the quickest fix possible and Neuromod are the closest to that as it seems at this moment in time.

What I would say about the alleged €23 million is that a lot of investment companies buy a load of 'biotechs' and a lot of them fail, with the hope that the one that is successful outweighs the losses from the other failures.

 

[Watasha]

What I would say about the alleged €23 million is that a lot of investment companies buy a load of 'biotechs' and a lot of them fail, with the hope that the one that is successful outweighs the losses from the other failures.

@Paulmanlike I am sure that investment companies definitely diversify, but I'd also add some color that these people don't make blind investments either. I am confident that some due diligence was done before offering up capital and it was based on more than just hope.

 

[Paulmanlike]

Podium description from Neuromod's next presentation. Accidentally "published" and postdated to March 3.

View attachment 26941

Just curious where you found this? And post-dated to March 3rd, does that mean we will see more info then?

 

[Agrajag364]

I wonder why they included anyone who had tinnitus less than a year. There is a good chance that tinnitus decreases or disappears with anyone who has had it less than a year. I wonder if they took this into account.

Well that's only going to improve their results seeing as they don't have a placebo group.

 

[annV]

Well that's only going to improve their results seeing as they don't have a placebo group.

And that's probably why they allowed those with tinnitus for less than a year into the trial. To make the results look better. And they don't have placebo group... this smells!

 

[Agrajag364]

And that's probably why they allowed those with tinnitus for less than a year into the trial. To make the results look better. And they don't have placebo group... this smells!

Yeah that was my reluctant suspicion yesterday. Why did they say they were going to include a sham control group but then not actually include a sham control group? In both current ongoing large trials all the arms are active comparators i.e. no placebos.

Doesn't mean the thing won't work for some people but the results would've been more valuable had they included a sham placebo arm, based on my limited understanding of this field.

 

[Paulmanlike]

In the past all good results have come from trials from the developers of a product. I also found tonal tinnitus was part of the inclusion criteria for the TENT-A2, perhaps that was more responsive, again, has that been done to improve the results of the TENT A-2? It was mentioned tonality/intonality didn't matter, so why have tonal tinnitus as part of the inclusion criteria in TENT-A2?

 

[GlennS]

And that's probably why they allowed those with tinnitus for less than a year into the trial. To make the results look better. And they don't have placebo group... this smells!

IMHO, there should be a 2nd Tinnitus Talk Q&A session with Neuromod where these sorts of questions can be put to them.

BTW, I don't know how you actually do a placebo with something like this. A sugar pill is one thing but if the thing isn't stimulating your tongue then you're going to know it. And if you adjust the synchronization of the stimulation intentionally to a setting that "doesn't work" it could potentially have unwanted side-effects of its own rather than doing nothing.

 

[Agrajag364]

IMHO, there should be a 2nd Tinnitus Talk Q&A session with Neuromod where these sorts of questions can be put to them.

BTW, I don't know how you actually do a placebo with something like this. A sugar pill is one thing but if the thing isn't stimulating your tongue then you're going to know it. And if you adjust the synchronization of the stimulation intentionally to a setting that "doesn't work" it could potentially have unwanted side-effects of its own rather than doing nothing.

The fact they said in the 2016 paper they would do a sham control for the next trial indicates they thought it was possible.

Last Q&A must have been a lot of work for the few Tinnitus Talk volunteers!

 

[Drone Draper]

Fuuuudge. When will this thing launch already?