Lenire — Bimodal Stimulation Treatment by Neuromod

[GlennS]

I don't want to 'spoil' the Neuromod interview such that nobody feels compelled to join Patreon, but I will say this:

The most relevant segment in relation to this thread (the question not quite as pointed as I was hoping) starts at 1:14:30. I don't know if it's a function of when the interview was done or Ross is punting but we get a non-answer. Based on what he says after that it really does look like they are treating the first batch of patients in particular as a de-facto "TENT-A3" experiment. And where they draw the line on early adopters is unclear. Presumably, when they start signing people up for 2020 they wouldn't be part of this group? Who knows? But for the foreseeable future, the only field data we're going to get is outside of Neuromod.

So those complaining that this kind of data-gathering isn't rigorous enough, you'll have to wait indefinitely for Neuromod to let the public know how people are actually getting on in the real-world.

Also, no hint of when it might arrive in the US.

Beyond that, I have noticed how Ross seems to slow down and stutter a little when confronted with sensitive questions. It happened in the first interview when he was asked about MuteButton and it happens again here in relation to measuring efficacy.

You'll all have to come to your own conclusions.

I don't deny they are trying to make something that works. How much it really works in its current iteration is a riddle wrapped in an enigma.

 

[UKBloke]

The most relevant segment in relation to this thread (the question not quite as pointed as I was hoping) starts at 1:14:30.

I concur. The question around 1:14:30 is the one I'd also been hoping and waiting for.

 

[UKBloke]

Beyond that, again -- we had to expect that in the best case there would be a lot of Lenire failures based on their own data

This is a really key point for me. From what I understand from the two interviews Ross O'Neill gave Tinnitus Talk, shortcomings on Neuromod's (let's call it) Protocol 1 trial phase, drove them to design Protocol 2.

In Protocol 1 patients were treated for just 6 weeks. I think the stats for this went something like 2 out of 3 patients reporting "clinically significant" improvements. Seeking better results, Neuromod instigated Protocol 2, which was essentially adding another 6 weeks of treatment and making some timing changes to the device.

Crucially after completing Protocol 2, 80% of patients now reported clinically significant improvements. 80% is quite a high number so surely we should see some kind of reflection of this on the user experience threads here at Tinnitus Talk?

 

[ruud1boy]

To ruud1boy:

What concerns me is your comment that "any future visits would be chargeable."

In that case, if you elected to have these future visits, what could be the cumulative total cost?
I recall that after I finished with Desyncra I was told that future visits for recalibration would also
be in addition to the $5,269.00 original charge.

Inwardly, I exploded - "What?" I said to myself - You already charged me this amount when it had no effect and you have the gall to have it cost more?"
"What do you expect me to end up doing? Sell my house and live in a Single Room Occupancy Flophouse, so I can pay for all of this?"

To be honest, it didn't concern me at all. They made it plain that the initial 'package' fee comprised 4 visits - assessment, fit, review #1 & review #2. The merits of the 'fit' appointment are debatable, but that's what you get when you stump up your cash initially. It isn't realistic to expect a commercial outfit to offer open ended support without additional fees - otherwise you'd end up with people camping out on their doorstep.

I got the impression that Neuromod were keen to see clients returning often and frequently - not from a perspective of earning repeat fees (for want of a better phrase), but more to gather the data and refine the treatment if necessary. There were no numbers mentioned about how much a further consultation might cost, but I'd be willing to bet it'll be €100-200.

 

[ruud1boy]

I make it two better — RedKnight and drcross, both with fairly new tinnitus.

Three unsure — Big Nick, TinMan, jacob21

No improval, or no improval as yet — ruud1boy, Cojackb, Liz Windsor

One worse, probably due to Lenire — Allan1967.

I agree with those who say a sample size of 9 is rarely wildly unreflective of a bigger sample of 500 (though it's not impossible), i.e. if 2/3 of the 500 in the trial truly got better, it's odd only 2 of 9 have reported that here.

I was more uncertain a few weeks back when a few people thought they might have improvals they are now unsure about. But not everyone has completed their sessions.

So it's still uncertain but it's not looking good.

Peter Pan's more rigorous analysis of a larger number of Tinnitus Talk users should be much more telling though. I bet we get to hear about that before Neuromod's TENT-A1 trial comes out.

People sometimes don't realise how bad a proportion of the medical literature is. Even really commonly used products like antidepressants - the evidence supporting their use in mild or moderate depression, evidence for their effectiveness above placebo, is quite poor. This was in contrast to early papers on the subject. I still had a small amount of hope for this product though during the discussions early this year. They did a really big trial.

I'd still like to see the TENT-A1 results published.

In the interests of balance, there is also a BTA member who's also experienced a severe 'disimprovement' after using the device. His tinnitus has got worse and his hyperacusis has gone through the roof apparently.

 

[ChrisBoyMonkey]

In the interests of balance, there is also a BTA member who's also experienced a severe 'disimprovement' after using the device. His tinnitus has got worse and his hyperacusis has gone through the roof apparently.

I like how you're quoting Dr. Ross' euphemism. Still, let's not beat around the bush and call them worsenings.

Was it just an initial one or he stuck out though the treatment and it still stayed worse?

 

[RCP1]

I am absolutely convinced those initial patient testimonials were actors. May be worth trying to track them down.

 

[Harley]

I am absolutely convinced those initial patient testimonials were actors. May be worth trying to track them down.

I think companies use actors on regular basis and this practice is widely accepted in commercials.

For example I'm pretty sure that the people in the herpes commercial never actually had herpes, etc...

Their professional like composure and scripted, vague wording were a dead giveaway that they were indeed paid actors.

There is no doubt in my mind about that one.

 

[Ruse]

I am absolutely convinced those initial patient testimonials were actors. May be worth trying to track them down.

Ken has already been tracked down and is a confirmed tinnitus sufferer who was on the trials.

Sorry to burst the bubble on this one.

Edit: some of the anti-Neuromod group will also be disappointed to know that he had a 30% reduction in VOLUME.

 

[Carltonr]

Thanks to @Hazel and everyone involved in producing the podcast. I thought you did a great job of covering the main issues.

I was especially interested in the part about the Bluetooth and his theory on why the treatment can make the tinnitus temporarily worse. (I did have to Google "Benelux" at the end though, couldn't work out what country he was talking about!!)

Dear Emma33,

Somehow I did not catch in the podcast the portion: "...about the Bluetooth and his theory on why the treatment can make the tinnitus temporarily worse...".

Can you tell me at what time-step this portion was discussed? Thanks.

 

[JayBowson]

Edit: some of the anti-Neuromod group will also be disappointed to know that he had a 30% reduction in VOLUME.

And a removal of his spikes to boot. Which isn't the first time we've heard this kind of feedback from a Lenire user. But sure, no need to let a little thing like facts get in the way of some good ol fashioned scaremongering.

 

[Alex Matyjasek]

I am absolutely convinced those initial patient testimonials were actors. May be worth trying to track them down.

And what about the other videos that were found on YouTube that nobody knew about? They were very disappointing and I´m not surprised that Neuromod doesn´t have them on their website. Compared to the first ones, did they really need to get actors? Doesn´t make sense. They simply got the best patients they could find and who knows how many there were...

 

[Bndsmheowqhe]

And a removal of his spikes to boot. Which isn't the first time we've heard this kind of feedback from a Lenire user. But sure, no need to let a little thing like facts get in the way of some good ol fashioned scaremongering.

The second there's a vague positive response all of the protestations involving statistics and sample sizes suddenly go right out the window.

 

[Emma33]

Dear Emma33,

Somehow I did not catch in the podcast the portion: "...about the Bluetooth and his theory on why the treatment can make the tinnitus temporarily worse...".

Can you tell me at what time-step this portion was discussed? Thanks.

They were two separate sections - he talked about the Bluetooth and he also, in a different section, talked about why the treatment can make tinnitus worse (temporarily).

Sorry, that wasn't clear in the way I wrote it.

 

[linearb]

Edit: some of the anti-Neuromod group will also be disappointed to know that he had a 30% reduction in VOLUME.

Oh, this is patently ridiculous. The most skeptical people in this thread are not actively wishing the device to be a failure. There's a big difference between being uncertain if a product works as advertised, and actively hoping that it doesn't for sake of... spite and self-harm? I mean, seriously, there is no person in the world bothered enough by tinnitus to be on this forum, who actively wants ongoing treatment efforts to fail. Give me a break.

So those complaining that this kind of data-gathering isn't rigorous enough, you'll have to wait indefinitely for Neuromod to let the public know how people are actually getting on in the real-world.

Right, and this obviously underscores the problem with throwing VC dollars behind cutting edge medical treatments. On the other hand, it worked out well for United Therapeutics...

Also, no hint of when it might arrive in the US.

These two things (the data, and a US date) will likely arrive together, if at all -- because my understanding is that while the original Irish clearance given to MuteButton has been allowed to apply to Lenire (which seems dubious to begin with to me, if the technology has actually advanced significantly) -- but the data which got MuteButton cleared in Ireland was insufficient for FDA. To clear FDA, they're going to have to cough up substantially more safety & efficiency data from actual clinical sources than they have to date -- because they did all their own studies behind closed doors and have mostly just published their own meta analysis. With no placebo control.

Contrast all this to what UMich is doing: completely normal Phase I -> II process, crossover placebo design, all actual results published as conventional research in peer reviewed journals. This doesn't mean that Lenire will fail, or that UMich will succeed -- Lenire may even be the better technology. We'll know eventually.

 

[erik]

Crucially after completing Protocol 2, 80% of patients now reported clinically significant improvements. 80% is quite a high number so surely we should see some kind of reflection of this on the user experience threads here at Tinnitus Talk?

80% has been the reported "magic number" of success for several tinnitus devices going back a decade or more. It was even kind of a joke here on Tinnitus Talk a number of years ago. And of course, none of those "80%" devices ever had any meaningful results for real world tinnitus sufferers.

Regardless, I really hoped that this device would be successful. People need some type of real relief.

Though my roaring loud tinnitus doesn't bother me 95% of the time, if there was a treatment to even reduce it 25%, I would still pay for it for the 5% of the time when it annoys me.

 

[ChrisBoyMonkey]

 

[GlennS]

Dear Emma33,
Somehow I did not catch in the podcast the portion: "...about the Bluetooth and his theory on why the treatment can make the tinnitus temporarily worse...". Can you tell me at what time-step this portion was discussed? Thanks.

It's in there but there's not much to hear. They just claim they understand the latency and are somehow compensating for it. Of course, they may not be successful in compensating, but they're claiming they are.

 

[AfroSnowman]

So having listened to the new Tinnitus Talk Podcast interview with Dr. Ross O'Neill, I still have a question.

Is this basically the same or different than Susan Shore's approach (and can we have a thread obsessing about the University of Michigan study please?)? From what I understand from the interview the idea behind Neuromod is that it disrupts by stimulation what's going on between the damaged aural nerve complex and the brain in the hopes that neuroplasticity will reset the connection in a less maladaptive pathway.

I think when I listened to Susan Shore she was speaking more about her technology calming the overactive nerves.

I'm no brain scientist nor do I intend on becoming one, I've got enough specialties already, so I am only speaking in generalities. Is this correct or did I miss the boat on this?

If so it is consistent and interesting that Shore's device seemed to offer more immediate relief that faded quickly when use stopped while Neuromod (take out your knives and hack each other up over all the unknowns) claims to have had a measurable long term effect.

 

[Ruse]

Oh, this is patently ridiculous. The most skeptical people in this thread are not actively wishing the device to be a failure.

Obviously the sarcasm has been completely lost on you there.

Don't get your knickers in a twist. It was a satirical comment in response to the accusations that Neuromod are now using paid actors in their testimonials.

 

[linearb]

Obviously the sarcasm has been completely lost on you there.

Don't get your knickers in a twist. It was a satirical comment in response to the accusations that Neuromod are now using paid actors in their testimonials.

Fair, my sarcasm meter is indeed broken after the last 20 or 30 pages here.

Even if that were true (paid actors) they would just be doing what every other drug and device manufacturer does. At least in the US.

 

[UKBloke]

if there was a treatment to even reduce it 25%, I would still pay for it for the 5% of the time when it annoys me.

I feel the same way. If I could dial it down just one subjective notch during the roaring periods, coping would be much more straightforward. I guess time will tell whether or not Lenire is going to give us that breakthrough.

 

[UKBloke]

(and can we have a thread obsessing about the University of Michigan study please?)

This would be great!

 

[COYS]

I had a while off the forum and just checking in.

Good to see this thread is as argumentative as always.

What's the general view on Neuromod so far?

 

[JohnAdams]

For example I'm pretty sure that the people in the herpes commercial never actually had herpes, etc...

Imagine not actually having herpes, but being an actor for a herpes cream commercial, and then being out at a bar on a date and the commercial pops up on the TV and then trying to explain to your date that you don't have herpes.

 

[GlennS]

It was a satirical comment in response to the accusations that Neuromod are now using paid actors in their testimonials.

Some people have a cartoonish notion of how this works. It's not so much about conspiracies most of the time as much as it's marketing spin. Their euphemisms (disimprovement) for instance.

Also, if you listen to the interview you'll notice how Dr. Ross O'Neill tends to want to dazzle and demonstrate competence by giving long drawn out responses. It's very similar to the kind of thing you get from politicians.

The more sensitive the question, the more roundabout the answer so that by the time he was done you kind of forgot what the original question even was. If he had just answered the questions succinctly the entire interview would probably have been a half-hour or less.

 

[Watasha]

My next hope consists in looking forward to seeing if Dr. Shore's device is technically superior.
My ENT Doctor already mentioned that it showed real potential.

What did your ENT doctor have to say about Dr. Shore's device? Anything else?

 

[Harley]

Imagine not actually having herpes, but being an actor for a herpes cream commercial, and then being out at a bar on a date and the commercial pops up on the TV and then trying to explain to your date that your don't have herpes.

I'm pretty sure it happens to them quite often.

But on the bright side, it seems that the drug manufacturers seem to be at least moving away from making any references of "anal leakage", as being one of the side effects in their drug commercials.

 

[UKBloke]

Some people have a cartoonish notion of how this works. It's not so much about conspiracies most of the time as much as it's marketing spin. Their euphemisms (disimprovement) for instance.

Also, if you listen to the interview you'll notice how Dr. Ross O'Neill tends to want to dazzle and demonstrate competence by giving long drawn out responses. It's very similar to the kind of thing you get from politicians.

The more sensitive the question, the more roundabout the answer so that by the time he was done you kind of forgot what the original question even was. If he had just answered the questions succinctly the entire interview would probably have been a half-hour or less.

To be honest though, if it were say, an interview for TV, the broadcaster would typically shoot a ratio of circa 10:1. In other words, if it's a 3 min piece for the nightly news they'd shoot 30 minutes of video during which the interviewee would get to talk. Unless they're a politician who seem to love the sound of they're own voice, such talking can devolve into what may seem like rambling until of course it's all been heavily edited.

I'm actually glad the team at Tinnitus Talk gave us what feels like a reasonably clean edit in that respect. Also, as far as Ross O'Neill is concerned, with venture capital involved, there's obviously the commercial imperative to consider too so I'm sure he's quite conscious before he commits to making certain answers. In that respect, I think we're probably quite lucky that he gave Tinnitus Talk an interview at all. I'm sure he didn't need to.

That said, I still haven't quite made up my mind about Lenire. Dunno... I feel like it might be a case of having to wait at least 12 months to then get a bird's eye view of just what has exactly transpired during Neuromod's first market offering. And who knows what will transpire in between...

 

[Chinmoku]

Oh, this is patently ridiculous. The most skeptical people in this thread are not actively wishing the device to be a failure. There's a big difference between being uncertain if a product works as advertised, and actively hoping that it doesn't for sake of... spite and self-harm? I mean, seriously, there is no person in the world bothered enough by tinnitus to be on this forum, who actively wants ongoing treatment efforts to fail. Give me a break.


Right, and this obviously underscores the problem with throwing VC dollars behind cutting edge medical treatments. On the other hand, it worked out well for United Therapeutics...

These two things (the data, and a US date) will likely arrive together, if at all -- because my understanding is that while the original Irish clearance given to MuteButton has been allowed to apply to Lenire (which seems dubious to begin with to me, if the technology has actually advanced significantly) -- but the data which got MuteButton cleared in Ireland was insufficient for FDA. To clear FDA, they're going to have to cough up substantially more safety & efficiency data from actual clinical sources than they have to date -- because they did all their own studies behind closed doors and have mostly just published their own meta analysis. With no placebo control.

Contrast all this to what UMich is doing: completely normal Phase I -> II process, crossover placebo design, all actual results published as conventional research in peer reviewed journals. This doesn't mean that Lenire will fail, or that UMich will succeed -- Lenire may even be the better technology. We'll know eventually.

But if the FDA is that rigorous how come they approved Levo and Desyncra that are largely ineffective?