Lenire — Bimodal Stimulation Treatment by Neuromod

[COYS]

What does THI stand for? If I have tinnitus that I can hear in a room that is 40-50 dB, does that mean there's a chance of a 20 dB drop?

Or is THI about the perception of tinnitus?

 

[Wimais]

If someone buys Lenire and it's not working for them, they could sell it after trialing it for a couple of months to someone else on this forum who wants to test it. At a lower price of course. Half price.

So at least you don't lose €4000 if it does not work for you... The first buyer receives a part of his money back and the new buyer does not have to buy it at €4000...

 

[Mentos]

4000 euro is absurd. And I'll tell you why.

I've looked at the data for TENT-A2, arm 1. These are the most impressive results so far. For the people who were able to look at Humbert Lim's presentation: right graph, slide 26.

I digitized the data points and looked at the effect of the device as a function of the baseline THI. In other words, I wanted to know how much improvement in THI can one expect for a given baseline THI.

The result (see graph below) is that the effect in terms of THI points is about constant. Irrespective of the THI score at the start of the trial, people on average reported a decrease in THI of nearly 20 points. That's not nothing! But it's especially good news for those with mild tinnitus. For example, someone with a score of 30 can expect a 60% drop in his/her score yielding a score of 10, which is probably clinically significant. On the other end of the scale, someone with a score of 90 ends up with a score of 70 (a 20% drop). In fact, two people with a THI of about 90 ended up with a score of 80 in the trial (10% drop). That's still very invasive tinnitus.

The bottom line is that the relative effect of Lenire seems to be more significant for milder tinnitus. Or differently: the people craving this the most will derive relatively the least relief. The more desperate you are for the device, the less relative effect it will have for you - that's what *their* data tells me.

On top of that: notice the huge spread in the data. I've added a histogram of the effect sizes. Yes, there are people with a 50 point decrease in THI. But there are more people with 0-10 points decrease. In their data, 40% of people had a decrease in THI less than 15 points.

To me, these results seem not a good base to go and charge people 4000 euro. Especially if those people are the most desperate among us. I don't want to discourage people, but I think it best to look at the data and try to be objective and evaluate the expected results before forking over 4000 euro.

And I think this cautioning message should come from Neuromod and not someone on a forum.

P.S. I'll be happy to look more at the data if people think this is helpful.

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Super analysis.

My THI score today is 46 points (moderate impact), assuming 20 points reduction it would bring me down to 26 points which is mild impact.

My MML is around 15dB. I'm not an enthusiast of measuring THI since the fact that I can function on a daily basis (work, household), and THI does not reflect the emotional impact tinnitus has on me.

Still I would be willing to pay even €4000 EUR for a reduction of 20 points and go to mild impact, especially if this would go hand in hand with MML reduction of say 8dB-10dB, which would bring my tinnitus down to 5-8dB.

Trick with THI is that either with score of 46 or 26 I would most probably do exactly the same things in life, just my emotional impact would be lower which is not really that much reflected in THI.

That's why I would be more interested in MML reduction but somehow Neuromod does not focus that much on it, even though they should consider it as least with the same importance as THI.

Also the pitch matters, I have 2 tinnitus sounds, one is slight hum in left ear which does not bother me at all, the other is a cricket sound in the head which gives me all the pain.

Both sounds are more or less on the same MML level, one does not bother me at all the other distracts and yields anxiety. If Lenire eliminates the cricket and leaves me with this hum I would be more than happy in life.

 

[Ruse]

What does THI stand for? If I have tinnitus that I can hear in a room that is 40-50 dB, does that mean thhere's a chance of a 20 dB drop?

Or is THI about the perception of tinnitus?

Tinnitus Handicap Inventory - check out the questionnaire I linked a few posts back this is what they will have completed.

It does not measure tinnitus loudness, only the emotional effect of tinnitus on a patient.

I believe they did also capture Tinnitus Loudness Matching (TLM) levels, however this data has not yet been released.

 

[Agatha]

If someone buys Lenire and it's not working for them, they could sell it after trialing it for a couple of months to someone else on this forum who wants to test it. At a lower price of course. Half price.

So at least you don't lose €4000 if it does not work for you... The first buyer receives a part of his money back and the new buyer does not have to buy it at €4000...

What makes you think they will allow it to be re-programmed for another person?

I think the device will only work for the original buyer and it can't be resold and reprogrammed to a third party.

WE DON'T KNOW! REMAINS TO BE SEEN!

 

[COYS]

I see, thanks for the info.

I just did the THI test and it came out at 44. I guess if I got a 20 point reduction then Lenire would be worth it and make it more manageable.

 

[BowJohnson]

What makes you think they will allow it to be re-programmed for another person?

I think the device will only work for the original buyer and it can't be resold and reprogrammed to a third party.

We already know it can be reprogrammed though. They're doing it right now for the second leg of 6 weeks for patients in the TENT-A2 trials.

And since you'll be purchasing this treatment through a trained audiologist and not directly from Neuromod themselves it seems more likely that the decision to reprogram a second hand device will be at the discretion of your professional of choice.

Just my take on it.

 

[Ken219]

30 years and read it all.

 

[hopeful4future]

Super analysis.

My THI score today is 46 points (moderate impact), assuming 20 points reduction it would bring me down to 26 points which is mild impact.

My MML is around 15dB. I'm not an enthusiast of measuring THI since the fact that I can function on a daily basis (work, household), and THI does not reflect the emotional impact tinnitus has on me.

Still I would be willing to pay even €4000 EUR for a reduction of 20 points and go to mild impact, especially if this would go hand in hand with MML reduction of say 8dB-10dB, which would bring my tinnitus down to 5-8dB.

Trick with THI is that either with score of 46 or 26 I would most probably do exactly the same things in life, just my emotional impact would be lower which is not really that much reflected in THI.

That's why I would be more interested in MML reduction but somehow Neuromod does not focus that much on it, even though they should consider it as least with the same importance as THI.

Also the pitch matters, I have 2 tinnitus sounds, one is slight hum in left ear which does not bother me at all, the other is a cricket sound in the head which gives me all the pain.

Both sounds are more or less on the same MML level, one does not bother me at all the other distracts and yields anxiety. If Lenire eliminates the cricket and leaves me with this hum I would be more than happy in life.

How do you figure out your MML? Mine takes about 70 dB to mask, depending on the external sound. So would my MML be 70 dB?

 

[COYS]

Is Lenire genuinely promising or is it a pipe dream? I'm only 5 months into this so I don't know the background of past treatments etc.

 

[Ken219]

Is Lenire genuinely promising or is it a pipe dream? I'm only 5 months into this so I don't know the background of past treatments etc.

My experience is what is new is old. I recommend you don't follow history because you will be disappointed. Hope for the future!

 

[COYS]

It does seem very convincing that this genuinely works...

How long lasting is it though? I mean it's a 12 week program so it must be relatively long lasting?

 

[jmasterj]

I still think THI is a poor measure since it is so subject to the individual and one's perception. I took the test again today and I was a 34, so if Lenire worked I would be down to a 14, which is basically nothing. When I first got this new spike I easily would have been in the 80-90 range for THI.

I am curious to see what the MML numbers are. I am around 70 dB to mask mine.

 

[Jack Straw]

For a product that supposedly comes out in a month there is still a lot of questions we have. I wonder if Neuromod will be answering them or if the audiologists will be, who obviously won't know any of the answers.

I hope Neuromod will do another interview with us so we can get some round 2 questions in before purchasing the device.

 

[Watasha]

For a product that supposedly comes out in a month there is still a lot of questions we have. I wonder if Neuromod will be answering then or if the audiologists will be, who obviously won't know any of the answers.

I hope Neuromod will do another interview with us so we can get some round 2 questions in before purchasing the device.

This is a great idea. I wonder if they would be willing to do a roll-out Q&A etc that is released the same week as the product launch. Something that mainly covers what consumers can expect, etc etc. I think this would be of benefit to them as well. There is always the possibility they have a lot of uncertainties around the launch and may not have all of the answers yet.

 

[Markku]

I hope Neuromod will do another interview with us so we can get some round 2 questions in before purchasing the device.

This is a great idea. I wonder if they would be willing to do a roll-out Q&A etc that is released the same week as the product launch. Something that mainly covers what consumers can expect, etc etc. I think this would be of benefit to them as well. There is always the possibility they have a lot of uncertainties around the launch and may not have all of the answers yet.

I'll be sure to suggest this to Neuromod!

Will post an update when I have one.

 

[Jack Straw]

Something a lot of people don't realize or seem to be talking about is the possibility of repeating the treatment.

Though Neuromod has no information on this data, I wonder if repeated treatments will continue to have positive effects. Remember this treatment is for only 3 months. They mentioned in the interview that if someone had a repeat trauma they could potentially repeat the treatment for the same results.

I wonder if this means that the treatment could be repeated every year until the tinnitus is completely gone. Food for thought.

 

[Mentos]

How do you figure out your MML? Mine takes about 70 dB to mask, depending on the external sound. So would my MML be 70 dB?

I play a rain sound from my PC in silent room on the minimum level which masks it and I measured on my smartphone what is the sound level. It gave me 15 dB result, I know this might not be the most accurate but it is the best estimation I can do.

At the audiologist my result was 23 dB but this was 2-3 years ago and I think my tinnitus improved a bit since then.

 

[Don Tinny]

I play a rain sound from my PC in silent room on the minimum level which masks it .

When I read testimonies like these, I think my tinnitus is the worst in the world.

I should probably be happy if Lenire leaves my tinnitus at the same level as yours.

 

[TheDanishGirl]

I play a rain sound from my PC in silent room on the minimum level which masks it and I measured on my smartphone what is the sound level. It gave me 15 dB result, I know this might not be the most accurate but it is the best estimation I can do.

At the audiologist my result was 23 dB but this was 2-3 years ago and I think my tinnitus improved a bit since then.

I'm confused. Isn't 15 dB inaudible to most every human? I read that a bedroom is even 30 dB.

 

[Candy]

Neuromod are going to be at the BTA Expo - are the BTA backing the treatment?

The Expo will be in September...

I just saw it on the BTA's Instagram page...

Maybe they could bring people along who have started to use the machine or were part of the trial, that way we can ask them the questions we'd like to have answers to.

 

[cjbhab]

Took that THI and my handicap is 80 - catastrophic - not sure if that's an accurate assessment. To me catastrophic would be I can't get out of bed or do anything.

For me, I still go to work (quiet desk job) and play golf on the weekends and try to go out to some places with earplugs - but my lifestyle is completely different now and I'm depressed and miss all the things I used to do. So much pressure in my left ear that I wish would go away.

 

[jmasterj]

15 dB background noise is going to be different that 15 dB directly on your eardrum (yes, tinnitus comes from the brain). That is the best way I can explain tinnitus dB readings compared to ambient noise. I am sure someone can do better at explaining.

 

[Bob den Hartog]

I'm confused. Isn't 15 dB inaudible to most every human? I read that a bedroom is even 30 dB.

According to my audiologist, with these measures they're talking about '...above hearing threshold'.

 

[Mentos]

I'm confused. Isn't 15 dB inaudible to most every human? I read that a bedroom is even 30 dB.

I calibrated my dB meter so that in a silent bedroom it shows 0 dB. I think silence should mean 0 dB. Mine is definitely audible, I can hear it over TV most of times.

When I measured my MML at an audiologist it showed 23 dB but it was already 2 years ago and my tinnitus has probably improved since then.

 

[Watasha]

Took that THI and my handicap is 80 - catastrophic - not sure if that's an accurate assessment. To me catastrophic would be I can't get out of bed or do anything.

For me, I still go to work (quiet desk job) and play golf on the weekends and try to go out to some places with earplugs - but my lifestyle is completely different now and I'm depressed and miss all the things I used to do. So much pressure in my left ear that I wish would go away.

Do you wear any protection during golf for fairway metals/drivers? I still play golf as well.

 

[Mathew Gould]

I would assume that the THI baseline is the score on day 0 of the treatment as opposed to having any reference to the patient's tinnitus baseline.

For anyone who is interested please see a link to the THI questionnaire below.

https://www.ata.org/sites/default/files/Tinnitus_Handicap_Inventory.pdf

As has already been discussed THI score attempts to measure how tinnitus affects someone emotionally rather than to measure any perceptions of loudness / intrusiveness.

Is this the same test the people at Neuromod made their participants take that @SignalExec just posted? I would score about a 40 with mostly "sometime" answers.

 

[Mentos]

When I read testimonies like these, I think my tinnitus is the worst in the world.

I should probably be happy if Lenire leaves my tinnitus at the same level as yours.

Severe sufferers would like it moderate, moderate sufferers would prefer mild and mild sufferers want it totally gone, that's how we human beings are. Mine was severe for the first 6 months after a concert, then it subsided to the current moderate/mild level.

I know your pain and feel for you.

 

[Ruse]

Is this the same test the people at Neuromod made their participants take that @SignalExec just posted? I would score about a 40 with mostly "sometime" answers.

Correct - it is a standardised test!

 

[Jack Straw]

Severe sufferers would like it moderate, moderate sufferers would prefer mild and mild sufferers want it totally gone, that's how we human beings are. Mine was severe for the first 6 months after a concert, then it subsided to the current moderate/mild level.

I know your pain and feel for you.

If I could make my current tinnitus go back to mild, I would consider myself cured. Having mild tinnitus would have zero impact on my life at this point.