Lenire — Bimodal Stimulation Treatment by Neuromod

I had white noise and I was on PS1 the full time I used Lenire.

 

May I ask if you are using it once or twice per day? If yes, do you use it at the same time(s) everyday?

 

Twice a day in a row.

 

I'm thinking of restarting Lenire but I'm going through a pretty awful spike that's due to a split-second noise exposure am I have difficulty getting in touch with Neuromod so I thought I'd ask you guys your opinion and your experiences. Should I wait for this spike to hopefully subside on its own or should I restart Lenire.

Kind of desperate for some relief because this spike is pretty killer.

 

Mine has rainfall which has a white noise character to it.

 

Honestly it is hard to say as everyone seems to react differently to Lenire. All I can say is when I've had moderate spikes over the last 6 months, using Lenire seemed to reset my tinnitus to its normal level. But I doubt I would have tried it if the spike had been intense.

 

Are you able to get custom-molded earplugs?

I have a pair with filters specifically made to let though human speech and muffle and lower most of everything else, and it helps a lot.

 

Where could I find out more about this?

 

The most bothersome thing about my experience with Neuromod is how little they seemed to know, or at least how little they let on. Almost every question I asked was answered with a vague response that bordered on "we don't know."

After a year, I would have hoped they could have gathered more data, or at least have more fruitful answers. I reached out asking about Dr. Hubert Lim and if they have gathered any significant findings during this period. If I get a meaningful response, I will update here.

 

@PeterPan, @Hazel, @Markku, @Autumnly and study participants,

I'm a little late to the party but I wanted to thank you all for your study and report. The infographic, the video, and the report set a wonderful example for what a patient group can do on its own. The results were presented clearly for people who may be either inside or outside of the research community. You addressed the impact of those who did not complete the study directly and clearly.

A few comments and no need to respond. Forgive me if these were addressed.

1. The hyperacusis component was interesting. I remember that the results from your 2016 survey showed that those with hyperacusis did not respond as well to sound-based tinnitus therapies (on average). This seems to show the opposite result which makes me more curious about what why this might be more helpful for reducing tinnitus in people with hyperacusis (or if perhaps a change in survey structure had some effect).
2. I would recommend using "participants" or "respondents" instead of "patients" for reports in future projects. It may avoid confusion about whether or not there is a patient-provider hierarchy.
3. When presenting the before and after values of an outcome variable (TFI in this case), I sometimes find it to be enlightening to use the change in outcome (TFI) for the Y-axis instead of the final TFI. This can emphasize the impact or lack of impact of initial TFI. For example, such a graph can clearly show whether or not people with a higher TFI are more likely to have a larger change in TFI after 12 weeks.

Great job and thanks for all of the time you put into this. It is very impressive!

 

Hi guys,

I want to share here as well that I corresponded with Dr. Hubert Lim yesterday just out of curiosity asking about the prospects and current state of the Minnesota device. His reply has some reference to Lenire as well, so I decided to put the link here, too.

"Hi Daniel,

Thank you for your interest in my lab's research on tinnitus. Based on past animal research from my lab, we discovered that sound combined with electrical stimulation of the ear or of the tongue drives strong plasticity/changes in the auditory brain relevant for tinnitus treatment. As a result, we pursued a human study in my lab with electrical stimulation of the ear combined with sound stimulation. My part-time PhD student who oversaw that study is still analyzing those data and will prepare a manuscript for journal submission. In the meantime. I also began working with Neuromod Devices in Dublin, Ireland to help them develop their approach with electrical stimulation of the tongue combined with sound stimulation, mainly because of the positive results we found in my lab's previous animal research. Although the original intention was to build a multi-modal device through my lab, Neuromod Devices already had made considerable progress towards a medical device ready for human use. So, I felt that the quickest and most effective route to getting a treatment option to the tinnitus community would be to work together with Neuromod Devices rather than build a completely new medical-grade device in my lab, which as you can imagine takes many years to get to clinical use. Therefore, I started to work with them to ensure we can share and combine our ideas towards creating the best treatment option possible between our teams.

Hope that answers your question.

Wishing you continued health during these unique covid times,

Hubert"

I plan to go on asking about the possible integration of the research done at UoM into Lenire and the timeline of that.

 

I think they are sincere and they don't know themselves, so they stay vague. To their credit, it's refreshing to see they openly admit they don't know. I saw ENTs and audiologists so sure of themselves in making patently inaccurate claims that Neuromod's attitude is truly refreshing. They are gathering data for sure but before this is analyzed it will take a while.

I think the scientific paper with the trial results and discussion should be out soon. Even discounting a long peer review, it's time now, I hope it will be out in one or two months.

Lim should have kept working on the Minnesota device, as we were saying above. He has probably been attracted by the comp and the impact aspect of working with industry, that is more and more important for academia, so he dropped the very promising work he was doing in Minnesota to help Neuromod. This is a pity as the Minnesota approach looked much more refined than Lenire. It's possible Lim has signed a no-competition agreement for 3-5 years and so he might not be working on finalizing and commercializing the Minnesota device. This is a crime and really a pity.

In Neuromod's favour, at least they dared to come out with a product that can offer immediate help to some of us. Susan Shore is taking the safe and fully conservative approach but this is taking ages, how many people could she have saved if she had sped up a little? It's a tough trade-off, helping early vs helping with more safety and precision but much later. These are all good people but I can see many scenarios where things could have gone much better for tinnitus sufferers, especially severe sufferers. I think we have been relatively unlikely. In a world with a minimum of sense, the Minnesota device would be already out or about to come out. Instead, despite the success in past trials, it's collecting dust somewhere in Minnesota. Sigh.

 

Someone should send Lim the Tinnitus Talk user experience report--then ask him to revive the Minnesota device somehow.

That being said, it could very well be that Lim's reprogramming concept has been part and parcel of Lenire's lack of efficacy so we may be overestimating what the Minnesota device could accomplish. I mean, all we had was really one anecdote (@kelpiemsp).

 

You may be right, although I found attractive that they used a brain scan to tailor the device to individuals, rather than just an audiogram stopped at 8kHz.

 

Very good point, GlennS.

I would be very curious to learn of the responses from all three of the main players, Lenire, Minnesota, and Dr. Shore regarding Tinnitus Talk's Lenire user experience group results.

I am still undecided whether I would actually try the Lenire device if and when it is available here.
However, imagine going to purchase a microwave and having the floor salesperson tell you, "2 out of 5 of our customers had some warming of their food to varying degrees, 1 out of 3 had no warming, and 1 out of 5 had malfunctions that resulted in fires." How ready would you be to hand over your credit card?

 

Let's not forget they first came out with MuteButton - a half-baked product that they silently took off the market.

Let's not forget they still have not published peer review results from TENT-A1 or TENT-A2.

Neuromod should be held up to a lot more scrutiny.

 

Unfortunately Neuromod can always just say "B.b.b.b.but COVID..." They probably feel they now have at least a 1 year free pass on any of these things.

 

Very good point, annV.

Would American FDA approval require that they release for general consideration these peer review results from TENT-A1 and TENT-A2?

 

How do you know this? I think this is a myth. They would have to be able to scan the brain with zillion times bigger resolution then what is available today. At the same time some artificial intelligence would have to analyze the data and come up with treatment settings. Such technology is not available and wont be available for some years, maybe decades.

If you or somebody else knows how they scan and how they use the data, I'm all ears.

 

Yes, that is why I used the word compromise. I agree on the scrutiny, I think the publication of the peer review paper should improve the scrutiny really and I would expect that to be imminent (but I am not holding my breath).

I wrote this in the past, I would have really appreciated if they had published the paper as a white paper/preprint, replacing it with the journal version later on. The CEO claims in the interviews that their work has been already reviewed to some extent via the academic conferences circuit, where they had feedback and a lot of questions/criticism (I think he says that in the Tinnitus Talk interview), but if it is so why not publish the paper then as a preprint? There I agree with you. However, I also see something positive in daring to come out once the company is confident the treatment is overall safe and works for a relevant amount of people.

 

Didn't the FDA approve Levo and Desyncra? (I may be wrong). What kind of peer review did they have for those devices if that was indeed the case?

As far as I understand, those treatments weren't very successful, so if the FDA approved those treatments, FDA approval wouldn't seem very relevant to me in terms of efficacy, except maybe to say that a device is safe, which is clearly important.

 

Good analogy but only up to a point. If there weren't any other ways to cook food, perhaps you would take your chances rather than eating raw/cold food all the time.

 

It's in the Minnesota thread:

The thread is here, worth reading:
https://www.tinnitustalk.com/thread...rch-with-acoustic-and-body-stimulation.28022/

 

Yeah I’m surprised there’s not more anger about this on the thread. They said they were about to submit for peer review in late 2018. They have not yet published. They have not come up with a plausible excuse. During this time they have sold a lot of devices on the basis of their quoted success rates. And if the Tinnitus Talk data is anything to go by, some people have got worse during that time.

 

To Chinmoku:
Perhaps I would rather eat raw/cold food than have my house go up in a conflagration; and a 1 out of 5 possibility would make me so apprehensive that I could not go into this with no real trepidation.

However, I still recognize the legitimacy of your point. In fact, today I notified my wife that in spite of having spent $5,269.00 on that useless Desyncra, after having had this for 6.5 years I would still spend $3,000.00 on Lenire or some similar treatment even if my ENT doctor notified me that there might be only a partial diminution. That represents the degree to which I have so had it with this.

 

I'm permanently down to 1x30 minutes of Lenire from 2x30 minutes.

Based on my sleep journal, going on 2x30 reliably starts spiking me after a few weeks, and once I stop the spikes also cease in 2-3 weeks. Sadly, it seems that it wasn't the second timing that did me in, but simply doing 2x30 mins. Doing 2x30 from the 1st timing is also giving me hell. I also get very quiet days but having a night with only 3 hours of sleep every 3rd or 4th day really gets old.

I'm sorry but I can't advise you. For me personally Lenire is not curing but causing spikes.

 

Update: instead of downshifting to 1x30 minutes, I've decided to suspend Lenire indefinitely. I may restart 1x30 minutes sometime in the future (maybe if they release an update or whatever).

I've given the device over half a year, and I've tried everything - the 1st timing, 2nd timing, 1st timing again, a long pause, the 1st timing at 1x30 minutes, the 1st timing at 2x30 minutes, etc. While the device does seem to affect my 1990 noises and decrease their volume, that's of no value to me, because I'm completely habituated to those noises. However, if I'm on Lenire, my 2016 noise spikes at night a lot more often (every 3-4 days) and doesn't let me sleep. That's causing a lot of fatigue and suffering.

Also, simply by using Lenire, attention is brought to tinnitus every single day. That's exactly the wrong thing to do.

For at least 2 years I was almost completely habituated to tinnitus - no distress during the day and bad nights once in a blue moon. That turned into frequent insomnia and hours spent obsessing over the current tinnitus volume almost every day, waiting for the promised relief to finally arrive. I took this for 6 months. Enough.

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Lenire definitely does something - it affects tinnitus; it did give me extraordinarily quiet days; I did have a few magical weeks back in December 2019. However, I also think that the device is very poorly understood. Those magical weeks never come back and Neuromod doesn't seem to be able to offer meaningful advice. They're well-intentioned, courteous and professional, and their device has great potential, but it needs a lot more data and refinement. I hope they'll be able to release an improved version that lives up to that potential.

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I'll now try and forget about tinnitus, which also means visiting the forum a bit less frequently. However, I'll linger around and will update you in a few weeks on how quickly the baseline returns post-Lenire.

 

Okay, I think I've heard, red and got enough to decide that I won't use Lenire anytime soon.
Let's hope that they will be fair with paper publishing/peer reviews and evaluate every single piece of knowledge/respond gained from this "publicly open trial" and utilize every available technology to get this treatment/device polished and bring Lenire v2 in next few years.

In the meantime, let's hope Dr. Shore will be able to complete her research, which will result in the release of treatment, also within a few years, as she is no longer the youngest with all due respect.

 

Has anyone with antibiotics/medication induced tinnitus experienced positive results from Lenire?

 

I'd like to see Tinnitus Talk gather data to determine how long-lasting Lenire's effect is because I remain thoroughly confused on this point. Neuromod said improvement should last whereas disimprovement should fade which never made any sense. There are still people who claim that Lenire helped them satisfactorily. Are they seeing their gains fade? What about others disimprovers? Is it fading or are they trying it again with other parameters to try to reset things?