Lenire — Bimodal Stimulation Treatment by Neuromod

[threefirefour]

Hey I'm all ears (pun intended) for accessible treatments. Like I said in the previous post the main thing holding me back is the financial investment required for the consistent travel. Has there been any news about Lenire making it to America?

As for Lenire 2.0 not being out until 2027, at least it's something to look forward to!

Well it is supposed to get FDA approval this year, but I don't know. Susan Shore should get FDA approval for her device this year or the next year and she's American so it's local.

 

[KyleM]

Well it is supposed to get FDA approval this year, but I don't know. Susan Shore should get FDA approval for her device this year or the next year and she's American so it's local.

Yep hopefully the Michigan device can come sooner rather than later.

 

[UHPTS]

and it was mentioned in the Tinnitus Talk interview.

Sorry, can you be more specific which interview it was? The one about Neuromod?

 

[Ruse]

Sorry, can you be more specific which interview it was? The one about Neuromod?

Dr. O'Neill mentions in the latest podcast that Neuromod will now be forming a partnership with the University of Minnesota (or something to that effect).

 

[UHPTS]

Dr. O'Neill mentions in the latest podcast that Neuromod will now be forming a partnership with the University of Minnesota (or something to that effect).

Yeah, but that doesn't mean that in 2027 there will be Neuromod 2.0 with Minnesota timing (whatever that would be). I would still like to know where @threefirefour is getting this info from. It's not in the podcast to which he pointed.

It's a pretty big claim he makes and that deserves providing the source of info.

 

[Markku]

Yeah, but that doesn't mean that in 2027 there will be Neuromod 2.0 with Minnesota timing (whatever that would be). I would still like to know where @threefirefour is getting this info from. It's not in the podcast to which he pointed.

It's a pretty big claim he makes and that deserves providing the source of info.

I would seriously question the legitimacy of such a claim. I'd be very surprised if Neuromod's relatively small team was already looking at a "Lenire 2.0" for 2027 when they are still only in the initial stages of expanding Lenire's availability.

To be frank, such claims are worthless chatter unless evidenced by something more concrete than "an inside source told me" and shouldn't be given much weight

 

[UHPTS]

Also I can not imagine Lenire saying "Hey, our current product is what it is. But wait in 2027 we will get you something much much better with much better timming. ".

Even if this was true they would have to be completely insane to come out with such info. It would mean the end to their business not talking about their so far only official business partner (Hannover) being stubbed in their back.

 

[GlennS]

With the talk in here of a Lenire 2.0 I am glad I decided to pull the plug and wait.

Did I miss a link or something? I thought the only talk about 2.0 has been figurative rather than anything Neuromod says they're planning to do.

 

[threefirefour]

Yeah, but that doesn't mean that in 2027 there will be Neuromod 2.0 with Minnesota timing (whatever that would be). I would still like to know where @threefirefour is getting this info from. It's not in the podcast to which he pointed.

It's a pretty big claim he makes and that deserves providing the source of info.

Yeah, but that doesn't mean that in 2027 there will be Neuromod 2.0 with Minnesota timing (whatever that would be). I would still like to know where @threefirefour is getting this info from. It's not in the podcast to which he pointed.

It's a pretty big claim he makes and that deserves providing the source of info.

Well I'm making logical conclusions. Here is where I'm getting my info:

1. The head of Sonic Labs (guys behind uMinn device) is working with Lenire.

2. I talked to @kelpiemsp and he said he worked with the researchers who assume that selling it to them / letting them use it is the plan. It makes sense. Sonic Labs is a research team, they're more likely to sell the timing to an established company instead of starting their own business.

3. According to the clinical trials site, their final trials will be done and dusted by 2026/7 and they aim to commercialize soon after. I assume it will be easier for them to get through the FDA because by then their will be neuromodulation devices already on market.

If all this is true; then that can only mean Lenire is planning on releasing improved uMinn timings around the year 2027.

 

[Bndsmheowqhe]

Well I'm making logical conclusions. Here is where I'm getting my info:

1. The head of Sonic Labs (guys behind uMinn device) is working with Lenire.

2. I talked to @kelpiemsp and he said he worked with the researchers who assume that selling it to them / letting them use it is the plan. It makes sense. Sonic Labs is a research team, they're more likely to sell the timing to an established company instead of starting their own business.

3. According to the clinical trials site, their final trials will be done and dusted by 2026/7 and they aim to commercialize soon after. I assume it will be easier for them to get through the FDA because by then their will be neuromodulation devices already on market.

If all this is true; then that can only mean Lenire is planning on releasing improved uMinn timings around the year 2027.

Everything you've said is logical and common sense. As such, be prepared for the onslaught of Flat-Earthers attacking you with their pitchforks.

The current version of Lenire appears to be intended as a placeholder in order to implement the necessary infrastructure for the eventual rebranding of the University of Minnesota device. It is eerily reminiscent of the infamous Star Wars empty box action-figure sets.

 

[Rigsbin]

Just arrived back from my 6 week appointment today at 7 weeks in.

Couple of bits of information to add, firstly the firmware on the device was updated (may help solve any sound glitches). Secondly, I asked about the difference between the programs and the change at 6 weeks. Apparently, the first program applied has no delay between sound and stimulation. The change at 6 weeks has a delay built in (around 13 milliseconds if I recall correctly) not enough to actually notice in use though. Unfortunately though, the tune stays the same! Was hoping for a bit of variety

 

[UHPTS]

Well I'm making logical conclusions. Here is where I'm getting my info:

1. The head of Sonic Labs (guys behind uMinn device) is working with Lenire.

2. I talked to @kelpiemsp and he said he worked with the researchers who assume that selling it to them / letting them use it is the plan. It makes sense. Sonic Labs is a research team, they're more likely to sell the timing to an established company instead of starting their own business.

3. According to the clinical trials site, their final trials will be done and dusted by 2026/7 and they aim to commercialize soon after. I assume it will be easier for them to get through the FDA because by then their will be neuromodulation devices already on market.

If all this is true; then that can only mean Lenire is planning on releasing improved uMinn timings around the year 2027.

Thank you bro for your explanation! It made things clear for me.

 

[hans799]

Going through a rough patch with Lenire lately.

To recap: my first 6 weeks were great (significant reduction subjectively, 10 => 6 MML objectively), then we switched timings and during the second 6 weeks the second timing caused one of my noises to spike.

I've been back on the first timing for 3-4 weeks now. Most of my tinnitus is back on roughly the same quiet level as after the first 6 weeks, which is great. But the noise which spiked during the second 6 weeks is acting like a real bitch. It's basically imperceptible during the day (I have to be in complete quiet or block my ears to hear it) but at night it becomes shrill and piercing and really disturbs my sleep.

This phenomenon has occurred when this noise was new. Neuromod says that I should keep going because if this phenomenon has faded once, it'll probably fade again. And of course I love how quiet the other noises are.

I asked if I could hasten progress by switching to 3 sessions a day, they say that could cause overstimulation and probably backfire. Also, they said that I could take a temporary break of 5-7 days and the spike should go down.

Right now I'm persevering, I'll push to 6 weeks (so 2.5 weeks to go). If the spike still persists, however, I'll take a break for 1-2 weeks.

I hope that in the future Neuromod will be better able to predict which timings work for which people, the first timing worked like a charm, it was the second one that screwed things up. My gut feeling is that if I just continued with the first timing I would have kept improving in an almost linear fashion. Now instead I get to fight this God damned spike that throws me all the way back to 2017 when I struggled with the exact same crap. Hope it ceases soon and I get back to the right track I was already on previously.

 

[UHPTS]

I hope that in the future Neuromod will be better able to predict which timings work for which people, the first timing worked like a charm, it was the second one that screwed things up. My gut feeling is that if I just continued with the first timing I would have kept improving in an almost linear fashion.

Wait for Lenire 2.0 with Minnesota timing! That will be the final cure!

...just kidding.

Looks like timing may be individual. No such thing as one timing fits all. Wish they published some science behind what they do regarding electrical/sound time shifts. I watched Dr. Shore's 1 hour talk on YouTube back from 2013. It was pretty sophisticated stuff she was talking about. Lot of science behind it. However only done on guinea pigs at that time.

I'm waiting for Hannover appointment willing to try this stuff. Lenire is collecting data from patients and have some big data specialists to extract something meaningful from it. The bigger the sample size the better. We see what AI can do to diagnose diseases these days. But first it has to learn from thousands of diagnoses/images... Lenire also needs lot of data and time to make some improvement or to learn to tailor the treatment to individual cases.

 

[Tybs]

it was the second one that screwed things up

I have the impression that the second set messes up a lot of participants... do they use the same order of sets for everyone?

 

[Agrajag364]

Neuromod has been guilty of opaqueness and doublespeak for some time now. They have created the perception among the public that the probability of statistically significant for anyone accepted for treatment is very high. But when asked, they have categorically refused to release any details other than things about hyperacusis sufferers being super-responders. * The closest to hard data we got was in a Vimeo video from a conference Hubert Lim did which was summarily smacked down by Neuromod. Then they gave all sorts of excuses for the lack of data:

a) peer review will take a long time... because muh data volume
b) data about those now using the device can't be released... because muh privacy

Despite that, they will gladly throw out exuberant numbers one-on-one when you're in the clinic to make sure you write the check.

If the public had nothing go by beyond their word that's one thing. But the user experience reports, limited in number as they may be, act as the verify part of trust but verify.

And how is that going?

Well, if nothing changes, then the conclusion in April will be that the trust can't be verified. There is a disconnect that needs to be explained.

Where should we go when that happens?

At the very least, Tinnitus Talk's data (and based on the preview, it's going to be really well done) should be brought over to them and they should be asked to answer for it in classic 60 minutes fashion. If they slam the door or give increasingly farcical answers then it will be pretty hard to hold onto that initial benefit-of-the-doubt trust.

* At least one (from memory) in the user experience thread reported he/she has hyperacusis but is not a super-responder.

Agree. Where is the peer reviewed publication of the results from TENT-A1? Here is a tweet from OCTOBER 2018 saying they were about to submit for peer review. SIXTEEN MONTHS on, nothing, and for a lot of that time they've been making money selling the device. Data crunching being time consuming does not sound like a feasible excuse.

 

[Lurius]

Just wanted to let you guys know that I'm going to Dublin tomorrow to pick up my device. I have extremely low expectations at this point, but still feel like I have to try.

 

[El BUZZ]

Going through a rough patch with Lenire lately.

To recap: my first 6 weeks were great (significant reduction subjectively, 10 => 6 MML objectively), then we switched timings and during the second 6 weeks the second timing caused one of my noises to spike.

I've been back on the first timing for 3-4 weeks now. Most of my tinnitus is back on roughly the same quiet level as after the first 6 weeks, which is great. But the noise which spiked during the second 6 weeks is acting like a real bitch. It's basically imperceptible during the day (I have to be in complete quiet or block my ears to hear it) but at night it becomes shrill and piercing and really disturbs my sleep.

This phenomenon has occurred when this noise was new. Neuromod says that I should keep going because if this phenomenon has faded once, it'll probably fade again. And of course I love how quiet the other noises are.

I asked if I could hasten progress by switching to 3 sessions a day, they say that could cause overstimulation and probably backfire. Also, they said that I could take a temporary break of 5-7 days and the spike should go down.

Right now I'm persevering, I'll push to 6 weeks (so 2.5 weeks to go). If the spike still persists, however, I'll take a break for 1-2 weeks.

I hope that in the future Neuromod will be better able to predict which timings work for which people, the first timing worked like a charm, it was the second one that screwed things up. My gut feeling is that if I just continued with the first timing I would have kept improving in an almost linear fashion. Now instead I get to fight this God damned spike that throws me all the way back to 2017 when I struggled with the exact same crap. Hope it ceases soon and I get back to the right track I was already on previously.

What about the rest of your sounds prior to your using of the device? Could you hear them all the time? Would you qualify them as severe before using Lenire?

 

[threefirefour]

Agree. Where is the peer reviewed publication of the results from TENT-A1? Here is a tweet from OCTOBER 2018 saying they were about to submit for peer review. SIXTEEN MONTHS on, nothing, and for a lot of that time they've been making money selling the device. Data crunching being time consuming does not sound like a feasible excuse.

They did but good peer review takes a while. This one actually isn't on them :/

For the other peer reviewers like Dr. Shore I assume it's because they're also very busy.

 

[RaZaH]

Picked up the device, first session today.

No spike after the first try at least, but the music is horribly monotonous and boring

 

[hans799]

What about the rest of your sounds prior to your using of the device? Could you hear them all the time? Would you qualify them as severe before using Lenire?

I was a moderate case before Lenire. Could hear the tinnitus over the car in a highway, for example. And I heard the noise over normal ambient sounds e.g. an office, too. But it wasn't super loud, either. I'd rate it as 4/10 on a bad day or 3/10 on a good day.

After the first 6 weeks I rated myself as 2/10, all sounds were still there but weakened, the burden of tinnitus as a whole was just a lot lighter.

 

[hans799]

I have the impression that the second set messes up a lot of participants... do they use the same order of sets for everyone?

I think the first timing (PS1) is the same for everyone and I faintly remember the audiologist saying that the second timing was "standard", too.

 

[Rigsbin]

Picked up the device, first session today.

No spike after the first try at least, but the music is horribly monotonous and boring

Tell me about it - had real problems staying awake during the first couple of weeks

 

[pinklights98]

Is anyone on Lenire trying anything to boost their neuroplasticity? I've been considering using CBD oil... thoughts?

 

[threefirefour]

Is anyone on Lenire trying anything to boost their neuroplasticity? I've been considering using CBD oil... thoughts?

Theoretically it could help tbh.

 

[Tybs]

I think the first timing (PS1) is the same for everyone and I faintly remember the audiologist saying that the second timing was "standard", too.

The last post in the reviews topic mentioned problems with the second set as well. One does wonder...

 

[mrbrightside614]

Is anyone on Lenire trying anything to boost their neuroplasticity? I've been considering using CBD oil... thoughts?

Don't waste your money. I think every supplement that boasts benefits to neuroplasticity are overblown.

Before tinnitus, ALCAR's subtle effect on cognition was apparent. I use Piracetam on a daily basis for the same reason. But everything that boosts BDNF, etc. is IMO worthless to a tinnitus-sufferer. Maybe ALCAR and cognition enhancers can stave off the neurological decay that occurs with chronic tinnitus-associated depression, but idk. I wouldn't go chasing waterfalls there.

 

[Sironketchup]

I think the best neuroplasticity enhancer is sleep.
Easier said than done with tinnitus lol.

So glad I have decided to stay on PS1 for 12 weeks

 

[threefirefour]

@KotaDomowa how much would you say your tinnitus has reduced in volume?

 

[Paulmanlike]

Still no sign of peer review anywhere.

Still no media attention from anywhere (without any links to Neuromod).

Is anybody else not convinced about Lenire? Even the positive stories are unreliable, I have good and bad times with my tinnitus, it would be coincidental that if I strapped myself up to a machine that I payed €2500 for it would help me combined with a placebo effect.

Isn't @PeterPan doing a survey so we can see Tinnitus Talk results?

I still hope this is the start of a real treatment, even if they are only working out now what works best.