Lenire — Bimodal Stimulation Treatment by Neuromod

Who should play @Markku and @Hazel in the biopic if tinnitus is ever wiped away? (Because the Tinnitus Hub deserves some credit if that day ever arrives.) I'm thinking Rami Malek and Cate Blanchett respectively.

In all seriousness, great job, Tinnitus Talk team! Once again, you've all done a tremendous service.

 

Hi Kriszti,

No, we did not ask a a question about changes in hyperacusis.

 

Thank you, PeterPan.

May I ask also, that because the improvements are based on the TFI survey, which is very subjective, is it possible that people with hyperacusis, who report success with Lenire also do have improvement on hyperacusis and that also has an impact on the TFI score? I didn't follow closely the user reviews of Lenire on Tinnitus Talk, so it's very possible that I missed people saying that even though their tinnitus was better, Lenire didn't affect their hyperacusis at all.

Also, a huge thank you for anyone involved in this survey. @Hazel, @Autumnly, @Markku, @PeterPan you are amazing. I'm in awe of everything you achieved with Tinnitus Hub. (And of course, this goes for all the wonderful staff members and volunteers of Tinnitus Talk.)

 

Yes, I guess this is possible. If you are experiencing less discomfort from hyperacusis then this may be reflected in the TFI score. It's hard to tell though. I recall that in the interviews with Neuromod, it was stated that patients experienced improvements in tinnitus, but not their hyperacusis. The good news is that if you suffer from hyperacusis, it seems you will more likely benefit from the treatment.

 

@Kriszti
Hi Kriszti!

I saw your question about if Lenire improved hyperacusis.

In my case yes. More detailed, I had mild-moderate hyperacusis, the worst days with bad tinnitus (6/10). The good days with very low tinnitus and there was no hyperacusis either.

Now after (and still using) Lenire my worst tinnitus days are 1-3/10 and on those days I no longer suffer from hyperacusis.

Best regards.

 

Does the 13.9% of THI also include the people Lenire didn't work for?

 

This is very encouraging news. Having someone on this forum who can report tinnitus/hyperacusis relief from a new development makes me feel like the medical community is beginning to understand this condition well enough to have medically-assisted success stories. I look forward to being able to have 1-3/10 days frequently myself.

 

A huge thank you to PeterPan and to the Tinnitus Talk team for the report.
Very valuable information but also information that makes the decision on whether to take the treatment or not harder.

Suppose someone has constantly worsening severe tinnitus. This can be masked only by very specific sounds that make it worse after prolonged masking. Without masking it's torture. This person in on the edge. She cannot go on much longer. Now Lenire claims 60% success in reducing symptoms and no permanent worsening. The survey here, although on a small sample, claims 42% success, 36% no change and 12% worsening/dropout. The 12% is worrying. One person developed trigeminal neuralgia.

What to do? This person feels she cannot go on much longer. But a permanent strong worsening could accelerate the end. Lenire has stopped tinnitus reactivity in some people and the survey has one case where tinnitus went from catastrophic to mild. 42% is not great but given the alternative, what should one do?

 

First and foremost I want to offer my sincerest thanks to all of you who worked so hard to make this study happen.

Your efforts are really really appreciated. Like Dave, I intend to make a further donation to the site and I would encourage everyone else visiting this thread and reading the report to do the same, no matter how large or small the amount you can afford.

There's no short answer to that, but:

Along the way, the Neuromod standard that I've held my expectations up to is their own trial data. For the record, we have here again their own scatter plot:



The chart on the right, Baseline vs Final, looks compelling and conclusive, even if the term "compliant subjects only" did introduce more questions here than answers. Nevertheless, the key point for me was always those two red dots (subjects) above the line of change on the right hand chart. Go above that line and one's symptoms become worse, or "dis-improve" as Neuromod term it.

According to their own data, out of 67 participants, 2 patients at Final experienced a worsening of tinnitus, which equates to a circa 3% chance. From day 1, this was the number I personally paid closest attention to because the relatively high odds of improvement made the 3% chance of a worsening worth the risk. Elevate that slim chance of worsening to 20%, however, and the situation changes entirely.

I hope Neuromod addresses this scenario as it doesn't seem to be a statistical anomaly to me (although I do acknowledge having zero experience in statistics). I would also like to see the elusive peer review of their data. It feels very odd to be in a situation where results seem to conflict with expectations to such a degree that one feels utterly compelled to do nothing but remain on the fence, however, this is where I am. I'm sure Neuromod don't want this for their client base, and I'm sure we don't want it either.

 

People who filled in reports at 13 weeks averaged a 13.9 TFI reduction (29 people). Some people dropped out and were lost to the study, and some people dropped out because of adverse outcomes. These dropouts were not included as they didn’t provide TFI data at 12 weeks.

 

Can it be assumed then that the additional dropouts due to adverse outcomes that are not included in the data would raise the chance of an adverse outcome to above 20% if they had provided data at 12 weeks?

 

I really don't understand why the fact that there are many different types of tinnitus and, hence, many different types of patient groups, is not paid attention to. Since we know for some decades that tinnitus may have a really large variety of causes, it should be very obvious that there is no single solution for all patients. If you have a success rate of, let's say, 60%, it is really huge in tinnitus.

Treatment cannot be compared with breaking your nose, the therapy being pretty much straight forward. If there is a correct subtyping of tinnitus types, we will see success rates of 100%, given that every patient gets the treatment he needs. For example, we know that tinnitus can appear without hearing loss. In patients with hearing loss, a good treatment is to provide hearing aids and potentially in the future to get them some medical treatment that lets their hair cells grow back, etc. This treatment is completely useless for people who have no hearing loss. Throwing together all patients into one group will only give a higher success rate if a larger subgroup of the patients responds good to the respective treatment.

The same holds for Lenire. Maybe they want to first sell their device to every tinnitus patient and ignore that it will not work for all patients. But as far as I know they are trying to figure out why it works better with some than with others. If the device will be effective in one subgroup, that'd be a great thing for those who suffer from the specific tinnitus subtype.

 

By excluding Lenire users who dropped out or quit, you introduce a selection mechanism that is steered towards positive results in regards to the TFI score. This is, to put it mildly, misleading.

 

We started with 43 patients. 6 dropped out due to adverse outcomes (14%). 7 (or 16%) dropped out for various reasons (e.g. device broke, did not respond at various milestones and lost to study etc). The remaining 70% provided data.

 

This is the part of statistics that really gets my goat!

Do the above figures mean that for the purposes of the Tinnitus Talk study, anyone considering signing up for Lenire must consider the chance of an adverse outcome to be 14%?

 

We had no choice. They didn’t provide data so we could only report they dropped out. We did, however, report on the number who dropped out and the reason for dropping out (e.g adverse outcome, lost to study etc). We also stated that the average TFI drop was the average for those providing TFI. If you have any ideas for improved reporting, suggestions are welcome.

 

That's how I interpret it...

Why has Neuromod not yet published their trial results? Makes me leery.

 

All we can say is that for our sample of 43 patients, 14% reported they dropped out due to adverse events

 

I’ve skimmed trough one document, but the caveat regarding TFI sample didn’t jump at me. But I’m sure you put it in. My point is that it is problematic measuring a treatment's efficacy solely via questionnaires of subjects' thoughts and feelings.

Anyhow, it looks like you did great work on this and I appreciate it a lot.

 

I don't want to manufacture drama over this but I would also consider those who dropped out due to adverse conditions to be totally worth including in crunching outcomes. The only rationale I can think of not to include them is the chance that if they stuck through it to the end that the disimprovement would have cleared. That's the matter of faith Neuromod expects from people but it seems to be too high of a burden.

At any rate I'd like to know how much lower the success ratio would go if these were included.

My armchair analysis of the thread was including them which might go a long way to explaining why it seemed like the "statistically significant" improvers were closer to a 1/3 or less rather than half.

 

Earlier posts suggested an intentional positive bias but I didn't. I understand after such a long wait there will be some drama and arguing over this data but I'm over it already.

BTW, I think COVID-19 has really set back the ability for Tinnitus Talk to draw more definitive conclusions here. If not for COVID-19 I would be urging Tinnitus Talk to continue gathering data and crunch things down after a healthier sample size was accumulated. As it is now there's no way to do this and so we're left with a small enough sample size that Neuromod can just lean on that as a convenient excuse for why the numbers don't match their trial data.

With Susan Shore now talking about 2021 or later and Minnesota nowhere near commercialization it seems that neuromodulation is now in indefinite limbo for all but those who are content with the risk/reward of these numbers once the lockdowns end, which, well, I don't think it will be me.

Anyway, one more for old time's sake.

 

Understood. I'm happy with the work on the report but still underwhelmed with this figure either way--especially factoring in the risk of worsening. I know it's not your job to absorb negativity in lieu of Neuromod. You're just the messenger. Thanks.

 

Great job, Tinnitus Talk team, thanks a lot for that!!!

 

If you are a patient in the US who already has Lenire, you are very much on your own. I emailed asking about the possibility of remote appointments and they said they cannot help me until 2021, despite having already paid for my six week and 12 week appointment, neither of which have I been able attend due to COVID-19.

 

Thanks. So actually the average TFI reduction is somewhat out of proportion as the people who worsened dropped out of the treatment?