Lenire — Bimodal Stimulation Treatment by Neuromod

[DaveFromChicago]

To hans799:

Thanks very much for the clarification. This information is among the best I have received for making a decision about getting this (if it is ever introduced in the American Market).

Nonetheless, a dormant, recessive sound that is activated by Lenire is as frightening as an entirely new sound; my tinnitus fluctuates so much that I can readily imagine a scarcely noticed sound becoming intrusive.

After six years of every effort having been defeated by this condition, I'm not sure that I have the fortitude to make this journey wherein I must wait out a new sound spike (for however long) that must finally disappear (the unfathomable horror being that it may not).

 

[GlennS]

Don't. Even if you get a new sound it'll be temporary. Lenire and other such devices don't have permanent effects.

That's what they say. How many in the user experience group have had their worsenings disappear completely?

 

[GlennS]

The way I understand it, no. These devices cannot cause permanent changes, that's not how they work. If you stop using them, you'll eventually revert to your previous baseline.

That's not how Lenire was advertised. They came to the conclusion that effects are "permanent" by following up on test participants months after treatment stopped and the effects had supposedly not faded. (For instance, none of those in the testimonial videos they posted were still using the device from the trials, at least they gave no indication of such. They were describing their new permanent baseline.) They are therefore advertising that the improvements are permanent (or at least long-lasting) and only the disimprovements are temporary. I have been questioning that asymmetrical logic for some time now.

In the grand scheme of things I am less concerned about improvements fading than I am about disimprovements sticking, but the initial hype around this treatment that generated so much interest in this thread surrounded the idea of being able to do a one-shot 12-week round of treatment and only hold onto the device as an insurance-policy.

 

[pinklights98]

but the initial hype around this treatment that generated so much interest in this thread surrounded the idea of being able to do a one-shot 12-week round of treatment and only hold onto the device as an insurance-policy.

To be honest, I would happily use Lenire every day for the rest of my life if it actually reduced my tinnitus. It's only an hour of treatment a day, and I think for those who it does work for they recommend that they reduce it to 30 minutes a day after sometime.

Unfortunately, I haven't seen any results to justify long term usage.

 

[MRItechssuck]

Well... at least the flights won't be full to Ireland... or anywhere for that matter. I'm proud of myself for thinking positive for once... kind of... lol.

 

[threefirefour]

That's what they say. How many in the user experience group have had their worsenings disappear completely?

Most of them. I keep track of all of them and so far the only two in my "permanent" category seem to have had a chronic worsening. One of those was Allan and the other I haven't been able to reestablish contact with to see if it hadn't waned. The rest either resolved or are in remission.

 

[hans799]

Had yet another good night, the 5th in a row. I'm starting to allow myself to think that the spike really is over.

In unrelated news there's a guy sitting next to me on the bus across the aisle. He is listening to music so loud on headphones that just the leakage from his headphones, through my silicone earplugs, is clearly audible. Wonder how many decibels are being blasted onto those poor cilia of his...

 

[GlennS]

One of those was Allan and the other I haven't been able to reestablish contact with

If you were really so detail-oriented and reading the posts here so carefully you would know why you can't reestablish contact with him. That is, unless this statement was intended as black humor, which would be wholly inappropriate. But it's stuff like this which is why I don't think your analysis should be taken seriously.

 

[Shelly75]

Most of them. I keep track of all of them and so far the only two in my "permanent" category seem to have had a chronic worsening. One of those was Allan and the other I haven't been able to reestablish contact with to see if it hadn't waned. The rest either resolved or are in remission.

Mine is still louder.

 

[hans799]

If you were really so detail-oriented and reading the posts here so carefully you would know why you can't reestablish contact with him. That is, unless this statement was intended as black humor, which would be wholly inappropriate. But it's stuff like this which is why I don't think your analysis should be taken seriously.

A bit of reading comprehension before attacking others goes a long way, Glenn.

He said ONE of them is Allan.

And it is the OTHER one he can't reestablish contact with.

 

[threefirefour]

If you were really so detail-oriented and reading the posts here so carefully you would know why you can't reestablish contact with him. That is, unless this statement was intended as black humor, which would be wholly inappropriate. But it's stuff like this which is why I don't think your analysis should be taken seriously.

I said one was Allan and the other was someone else. If you're so detail oriented how did you miss this? Does this mean I shouldn't take your analysis seriously?

 

[threefirefour]

Mine is still louder.

This is terrible sorry to hear. Thanks for telling me. I thought yours remissed a bit. I hope yours goes down.

Usually I say it needs to have stayed permanently heightened for 6 weeks for me to say it's a chronic worsening.

 

[Shelly75]

This is terrible sorry to hear. Thanks for telling me. I thought yours remissed a bit. I hope yours goes down.

Usually I say it needs to have stayed permanently heightened for 6 weeks for me to say it's a chronic worsening.

I started using it in July and finished in January. I'm pretty sure it's permanent now.

 

[threefirefour]

I started using it in July and finished in January. I'm pretty sure it's permanent now.

After treatment I mean. But yeah it's March now so I must have slacked. Sorry

 

[hans799]

6th day after stopping Lenire - spike was absent for the previous 5 nights, then came back again this night. Wonderful. Knocked myself out with 0.75mg Xanax so I could sleep. 5 good days in a row must mean that the spike is subsiding, right?

 

[Ruse]

6th day after stopping Lenire - spike was absent for the previous 5 nights, then came back again this night. Wonderful. Knocked myself out with 0.75mg Xanax so I could sleep. 5 good days in a row must mean that the spike is subsiding, right?

Had it ever previously subsided for 5 days?

 

[hans799]

Had it ever previously subsided for 5 days?

Hm, no.

 

[Lurius]

Hey, @hans799 you said something about changes caused by Lenire are not permanent. I do not agree with this, so I sent an email to Neuromod. This is what they said:

"During the clinical study, the patients used the device for a total of 12 weeks and were then followed up for a year afterwards. Many patients who noticed improvement in their tinnitus during the 12 weeks still reported that their tinnitus was better after a year of not using the device. This indicates that improvement/changes from Lenire can potentially be sustained long-term, even if the device is no longer used."

 

[hans799]

Hey, @hans799 you said something about changes caused by Lenire are not permanent. I do not agree with this, so I sent an email to Neuromod. This is what they said:

"During the clinical study, the patients used the device for a total of 12 weeks and were then followed up for a year afterwards. Many patients who noticed improvement in their tinnitus during the 12 weeks still reported that their tinnitus was better after a year of not using the device. This indicates that improvement/changes from Lenire can potentially be sustained long-term, even if the device is no longer used."

Well, 12 months is still not eternity... but it's definitely long term.

Let's hope this doesn't extend to spikes.

 

[Lurius]

Well, 12 months is still not eternity... but it's definitely long term.

Let's hope this doesn't extend to spikes.

I think you misunderstand. What they obviously mean to say is that the effects of Lenire can be permanent.

 

[AfroSnowman]

I'm going to wait a few more days to see if this holds true before doing a more formal report, but something interesting appears to be happening at around week 6. For the last 6 days I've remained below baseline. Not gone, largely still ever present but distinctly less intrusive and modestly but measurably more quiet.

Interestingly this corresponds to me switching my protocol from 2 x 30 minute sessions, one morning, one night, to a single hour long back to back sessions in the evening.

Just putting it out there to other users that you may get a different response from doing it an hour straight.

Peace.

 

[pinklights98]

I'm going to wait a few more days to see if this holds true before doing a more formal report, but something interesting appears to be happening at around week 6. For the last 6 days I've remained below baseline. Not gone, largely still ever present but distinctly less intrusive and modestly but measurably more quiet.

Interestingly this corresponds to me switching my protocol from 2 x 30 minute sessions, one morning, one night, to a single hour long back to back sessions in the evening.

Just putting it out there to other users that you may get a different response from doing it an hour straight.

Peace.

I'm going to try this. Thank you!

 

[AfroSnowman]

I'm going to try this. Thank you!

Good luck.

 

[ThomasRobert]

There's a new guy onboard... Florian Elsaesser.

https://www.hearingreview.com/inside-hearing/people/elsaesser

I have canceled my appointment anyways...

 

[GlennS]

Chief "Commercial" Officer? Never heard of that C-suite role before, but it does illustrate where their priorities are.

If I were in their shoes I'd be slowing down the rollout, not accelerating it, so they can focus on improving outcomes.

 

[hans799]

@hans799 has mild tinnitus, MML 10 dB if I'm right. He's happy with Lenire.

I'm sure he meant above hearing threshold and not MML. A MML of 10 dB is very very low, I wouldn't even call that tinnitus. It means it would be masked everywhere, even in quiet rooms.
And 60 dB is quite bad but I wouldn't call that catastrophic.

I realize this is an old post but I forgot to reply, apologies.

I just checked, Neuromod's audiologist wrote "MML - 10dB HL - white noise" on my original assessment form. So it's dB HL (Hearing Level), not dB SL (Sensation Level). I believe that means that it's an "absolute" value, not relative to my own hearing threshold.

 

[jmasterj]

Well it doesn't look like I will be going to Dublin for my adjustment in two weeks. It looks like no travel to the US from Europe for the next 30 days, so I am assuming I am not going to be able to fly over since I won't be able to get back!

 

[Ruse]

Well it doesn't look like I will be going to Dublin for my adjustment in two weeks. It looks like no travel to the US from Europe for the next 30 days, so I am assuming I am not going to be able to fly over since I won't be able to get back!

Ireland is exempt I believe.

It's only the 26 countries in the Schengen border-free travel area at this stage.

 

[threefirefour]

Well it doesn't look like I will be going to Dublin for my adjustment in two weeks. It looks like no travel to the US from Europe for the next 30 days, so I am assuming I am not going to be able to fly over since I won't be able to get back!

If you're an American national you can still fly back. Also you could fly to the UK still and fly to Ireland from there; but that's too much trouble.

 

[pinklights98]

I have repeatedly asked Neuromod about the possibility of remote device stimulation updates given the current state of travel and they have insisted this is not a possibility and remind me about how I was warned about the limitations of being a US patient given the lack of FDA approval and that there are no exceptions.

I wish they would work on developing a way to do remote device updates, considering the Coronavirus has made travel extremely difficult and scary.