Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[Sam Bridge]

Who said it is only effective for 2/3rds? Must have missed that bit.

 

[Kelvin]

Thanks so much for doing this Q&A. A very professional job.

Some promising testimonials from Irish trial patients here...

Would love to have a try and try and tone it down.

https://vimeo.com/neuromoddevices

 

[hans799]

Will watch this later today. But I read the comments to know what to expect. I'm so delighted to see that first impressions are good and this thing appears to be legit. We might be on the cusp of a historic moment here, akin to the release of the first antibiotic or the first antidepressant.

 

[Don Tinny]

Thanks for the work. Is the price of the device unknown? I assume they do not intend to sell it in Latin America.

I'm fried if they sell it at 3,000 USD. The ticket for the concert that damaged me cost about 25/30 USD.

 

[Bam]

Yep it is exciting - What I am delighted about is that the negativity has evaporated from the board now - He came across so well - so genuine, knowledgeable and well meaning that I don't think anyone could doubt the authenticity of the venture after watching the whole interview.

All I will say is watch the throat clearing and squirming in his chair when @Steve asked about percentage improvements in patients. We are still a long way from silence I fear.

 

[Philip83]

Great work! Will definitely go to Ireland and get one when it becomes available.

One thing I thought was a bit weird though was the treatment session duration. He kept saying 30 to 60 minutes. Well, 60 min is 100% more than 30, that's a lot. That's double the amount of hours over the 12 week period if you go with 60 rather than 30.

That seems like an odd, arbitrary factor in a trial like this, doesn't it?

How does one know what is ideal for oneself?

 

[Jcb]

Unknown at this point, Jcb. Neuromod have been so involved with the clinical program they haven't yet decided many of the business aspects. -TC

Thanks TC, from the way he explained it sounded like it may be rented. I'll wait for more info, am just overly curious about this and trying to keep a level head haha.

 

[david c]

Clearly a lot of hard work has gone into producing this Q & A - well done!

Now all that needs to happen is a new thread be set up when the device launches so that those members of Tinnitus Talk who have purchased the device can give feedback on how helpful (or not) they have found it.

 

[Krolo]

Who said it is only effective for 2/3rds? Must have missed that bit.

As I recall it was effective for most tinnitus + hyperacusis patients and 2/3 of the only tinnitus patients. My memory could serve me wrong here.

 

[Marko Nakovski]

I'm just confused about the part where it helps so much those who have tinnitus + hyperacusis.

How can a patient with tinnitus + hyperacusis have even better results on their tinnitus than someone who has only tinnitus, yet, it can't help the hyperacusis itself?

 

[RCP1]

All I will say is watch the throat clearing and squirming in his chair when @Steve asked about percentage improvements in patients. We are still a long way from silence I fear.

I thought his body language was consistent all the way through tbh.

 

[Autumnly]

I hope this thing will be soon available in Germany, otherwise I need to travel to Ireland.

I'm assuming as they worked together with Berthold Langguth and had trials in Regensburg that Germany will be one of the first countries to offer this device after Ireland (but I'm only speculating here).

Who said it is only effective for 2/3rds? Must have missed that bit.

As I recall it was effective for most tinnitus + hyperacusis patients and 2/3 of the only tinnitus patients. My memory could serve me wrong here.

He said the device helped over 80% and showed a clinically significant improvement in two thirds of patients.

 

[RCP1]

As I recall it was effective for most tinnitus + hyperacusis patients and 2/3 of the only tinnitus patients. My memory could serve me wrong here.

80% got a reduction.
67% got a clinically significant reduction.

 

[zoid]

It's been a while since I last logged in on Tinnitus Talk. When I got my tinnitus 4 years ago I thought my life ended but I'm glad I can say that I can manage my tinnitus and hyperacusis and live a happy live again despite the tinnitus some days screaming on top of all the sounds.

However, I'm very very exited about this development and I really hope it benefits a lot of people. Also hope it becomes available in the Netherlands soon, a little bit more silence is welcome.

Thanks to @Markku and @Steve and all the best to all the people on this forum!

 

[hans799]

80% got a reduction.
67% got a clinically significant reduction.

Let's also not forget that this happened when people used it only for the 12 weeks of the trial. The device exercises its effect through neuroplasticity - "teaching" the brain. So there's an excellent chance that if the "teaching period" is longer, the changes are even larger. Maybe a share of the 20% who didn't respond in 12 weeks will respond to longer periods. Maybe a share of the 13% who got a reduction but not a significant one will get a significant reduction with a longer period. This is something that literally only time will tell - but the initial signs are very promising.

Longer usage periods will also help provide the researchers with more data on who is not responding, and why. Once we have thousands of people using this for months, patterns should become much clearer. I can even imagine software updates, additional settings etc being released by Neuromod as they learn from usage data.

The fact that this is a device and not a chemical works greatly in our favor - it can be brought to market quicker, it can be updated, and there's much less risk of tolerance/dependence.

 

[dayma]

Looks like I am headed to Ireland next year for a vacation.

Really appreciate the folks that put this together for us.

 

[Steve]

Not a problem man - I think for all who have watched the Q&A from start to finish that Ross O'Neill and Neuromod are more than legitimate/well meaning/professional & scientific.

67% chance of meaningful reduction - They're good odds people.

Will be getting one in the new year - although January wasn't mentioned @Steve.

Is January the month it's coming out?

Yes, they said they are aiming for January.

Maybe @Steve knows. Plus you'll have to bring it thru customs- but depending on the cost you may or may not have to declare it. Remember, you don't want to mess with customs agents, they can make your life extremely unpleasant!

Yes, the customs thing would be an issue. It is a medical device and as it doesn't yet have FDA approval then you technically couldn't bring it in (technically ). I imagine a convertor would work fine for charging it.

Do we know what their definition of 'clinically meaningful reduction' is?

It's one of their primary end points and I suspect there might be a standard definition used across tinnitus research (e.g. a certain percentage reduction on THI). Would just be useful to clarify.

It's in the video. Also your other comment, that was the first thing we discussed.

 

[david c]

Yep it is exciting - What I am delighted about is that the negativity has evaporated from the board now - He came across so well - so genuine, knowledgeable and well meaning that I don't think anyone could doubt the authenticity of the venture after watching the whole interview.

What's really good about Tinnitus Talk is that it provides tinnitus sufferers with a forum where they can openly exchange experiences - good and bad - without the marketing cr**. So if this device is as good as they say - and given the high level of interest in it - within around six months or so of launching there'll be plenty of members posting on here about how great it is. And if it isn't, well the opposite really...

 

[Steve]

Thanks for the work. Is the price of the device unknown? I assume they do not intend to sell it in Latin America.

I'm fried if they sell it at 3,000 USD. The ticket for the concert that damaged me cost about 25/30 USD.

No pricing yet but come the Ireland launch you probably work from there on an anticipated price.

I'm just confused about the part where it helps so much those who have tinnitus + hyperacusis.

How can a patient with tinnitus + hyperacusis have even better results on their tinnitus than someone who has only tinnitus, yet, it can't help the hyperacusis itself?

That's a finding that surprised the researchers. We need to understand what it was, what the mechanism behind it could have been. That understanding could potentially open up some new knowledge on the processes underlying tinnitus and hyperacusis.

Let's also not forget that this happened when people used it only for the 12 weeks of the trial. The device exercises its effect through neuroplasticity - "teaching" the brain. So there's an excellent chance that if the "teaching period" is longer, the changes are even larger. Maybe a share of the 20% who didn't respond in 12 weeks will respond to longer periods. Maybe a share of the 13% who got a reduction but not a significant one will get a significant reduction with a longer period. This is something that literally only time will tell - but the initial signs are very promising.

Longer usage periods will also help provide the researchers with more data on who is not responding, and why. Once we have thousands of people using this for months, patterns should become much clearer. I can even imagine software updates, additional settings etc being released by Neuromod as they learn from usage data.

The fact that this is a device and not a chemical works greatly in our favor - it can be brought to market quicker, it can be updated, and there's much less risk of tolerance/dependence.

Absolutely agree. Neuromod can only say what their clinical trials have shown them, the data is from a specific dosing regime over a specific time period with a specific follow up period. There could be scope outside of this to increase efficacy and experiment further.

 

[TuxedoCat]

I am a bit confused. It is mentioned that the most recent study contained three arms, with differential stimuli frequency and synchronicity comprising the difference between arms.

But, all three protocols appear to have been expected to provide some tinnitus benefit, and there seems to have been no purely placebo arm (i.e. a stimulus and frequency combination that is not expected to have any effect).

Hi Manny,

Indeed there were 3 arms and there were improvements in all 3. However, compared to the other groups, the group that used high frequency synchronized stimulation had better sustained effects after they stopped using the device.

This was an exploratory study, so really the purpose was to choose the best frequency and timing of the stimuli to program into the device and carry that forward in additional studies.

Coming up with a true placebo for a device study can be extremely difficult. Ideally, all the subjects entering a study should have the same level of expectation for efficacy of the treatment they receive. If there were to be a group that simply put the headphones on and put the tongue tip in but never heard any sound or felt no pulses on their tongue it's doubtful they would have any expectation for efficacy at all and so they would be unblinded.

Also, in situations like tinnitus where the condition and treatment is unique to an individual, analyzing change from baseline as the statistic can be appropriate. In that situation the patient is serving as his or her own control. Better still in this type of situation is having a objective measure, which tinnitus doesn't have.

IMHO, addressing the topic of negative control and proper statistical analysis is something Neuromod probably struggled with while setting up their clinical program. This is one of the reasons peer review is important. No doubt Neuromod bashed things out among themselves including with some well known tinnitus researchers and key opinion leaders and made some decisions. Next they may have to go back and forth during peer review to defend and educate about their choices. Further complicating matters is the fact that clinical research for tinnitus treatments is pretty much in its infancy, so Neuromod are doing some real trail blazing here.

So in addition to proving their device, one has to appreciate the value of the Neuromod clinical program and looking at the subtypes that respond and those that don't respond to treatment. If you watched David Stockdale and Steve talk about the year in research you would have heard David talk about how studies of psychological treatments inform the study of tinnitus subtypes. The same thing is going on here.

TC

 

[jmasterj]

Yes, the customs thing would be an issue. It is a medical device and as it doesn't yet have FDA approval then you technically couldn't bring it in (technically ).

I just wonder if after visiting Ireland and consulting with an audiologist there they could just ship it to the US or another country for use. You could avoid customs that way I would think.

 

[Jack Straw]

I just wonder if after visiting Ireland and consulting with an audiologist there they could just ship it to the US or another country for use. You could avoid customs that way I would think.

They want to have the patients under the care of a physician or audiologist during all parts of the trial.

 

[grate_biff]

Enjoyed the Q & A video @Markku and @Steve. Well done!
Time will tell. I pray it will work for all of us.

 

[RCP1]

Wonder when the release date is going to be announced... Guess not until after Xmas.

 

[spedgas]

Here is my optimistic take from this video.

I believe this product will help a lot of people. It will definitely get better with time. The first release of the "MuteButton" was clearly not ready for prime time. This new device is essentially a first generation product. Neuromod has heaps of data they haven't even finished going through yet.

As they go through this data and other scientists get involved with their own similar devices these products will get more effective.

I envision a time where they can really dial these things into specific patients tinnitus profiles and achieve better treatment.

 

[Eric N]

They want to have the patients under the care of a physician or audiologist during all parts of the trial.

Does that mean my family doctor has to send them a request? Under the care is very vague term, what are they expecting the physician or audiologist to do. is it just for reporting the side effects?

Bottom line I need to try this ASAP. I'm not doing well at all. I don't think I can wait another year or so. I wonder if living in Canada will complicate matters more or not.

 

[Jack Straw]

The next question I would have for them is, after the first treatment what is the next step? Does the treatment repeat after a year? Would it have a compounding effect over time?

 

[Bam]

I thought his body language was consistent all the way through tbh.

28 mins in. He looked very uncomfortable. Throat clearing. Shuffling in chair. Lots of umming and repeating himself. I cannot be the only one who sees this? Watch it yourself........It's a clear lack of confidence in the results and if you don't believe me ask a body language expert.

 

[hitachi]

I'm feeling skeptical when @Steve asked Ross if he has any brain imaging data to measure the improvement (Question 28). His answer didn't convince me at all.

 

[Red]

I cannot watch the video without subtitles because of my hyperacusis. I apologize.

Does this work on hyperacusis?
Does it work on reactive tinnitus?
Can a Trigeminal Neuralgia patient use this device?