Lenire — Bimodal Stimulation Treatment by Neuromod

[RunningMan]

Ah, you're right. I was looking at the "intent to treat" population graph when I should have been looking at the "per protocol" one. It's 70% of the group that actually got the treatment who had a "clinically meaningful" TFI score reduction. It was 60% of the initial population but a bunch of people dropped out for various reasons. I don't know why they include both in the report...

Only the ITT includes ALL 99 study participants.

From the study for the Shore device:

Further analysis revealed that the proportion of participants who demonstrated a clinically meaningful reduction in TFI score (13 points) was significantly greater at week 6 of phase 1 of active treatment (PP population: 65%vs ITT population: 53%; PP population P = .003) compared with control treatment (PP population: 25%vs ITT population: 20%; ITT population P = .004) (Figure 2C
and D).

For the full study group, active treatment resulted in 53% with clinically meaningful improvement while the control (placebo) group resulted in 20% with clinically meaningful improvement. For the fully study group, the active treatment was 33% points higher than the placebo. For the PP subset, active treatment was 40% points higher than the placebo. Also keep in mind that there was criteria for being included in the study that made it more likely it would work for those participants than a random sample of tinnitus sufferers. If you included more people with greater hearing loss, for example, the numbers would likely look less favorable.

Based on all the feedback from Lenire users, it was less effective than these numbers coming out of the Shore study.

Lenire User Experiences and Reviews

 

[aarond23]

Lenire was featured on Good Morning America this morning, 12/26/2023. One person was interviewed who said it had helped her coping with tinnitus.

 

[RunningMan]

One person was interviewed who said it had helped her coping with tinnitus.

Yeah, she said she's sleeping better and got her life back, but she didn't say Lenire actually reduced her tinnitus at all, probably because it didn't.

 

[just1morething]

Lenire was featured on Good Morning America this morning, 12/26/2023. One person was interviewed who said it had helped her coping with tinnitus.

I've read the recent user experiences of Lenire on Tinnitus Talk and they don't sound too good. One of them got their Lenire from the Minnesota clinic that I called a few days ago. Seems like a thumbs down at this point.

 

[Pos]

Yeah, she said she's sleeping better and got her life back, but she didn't say Lenire actually reduced her tinnitus at all, probably because it didn't.

Habituation is no different to having your tinnitus reduce. Everyone on Tinnitus Talk is obsessed with reducing their tinnitus because they have not yet habituated to it and can't fathom what habituation even feels like. If Lenire can speed up people's habituation, thus allowing people to get their lives back, then that is a success.

 

[DeanD]

Habituation is no different to having your tinnitus reduce. Everyone on Tinnitus Talk is obsessed with reducing their tinnitus because they have not yet habituated to it and can't fathom what habituation even feels like. If Lenire can speed up people's habituation, thus allowing people to get their lives back, then that is a success.

Not true at all. I have had tinnitus since birth and I have never known silence. I have had mild, moderate and severe forms. I have been habituated too for over four decades. I can tell you from a lot of years of experience that this statement is very wrong.

Habituation is much easier when the tinnitus is mild to moderate, non-reactive and maskable. I was habituated many, many years, and it never bothered me - a 50% volume reduction probably wouldn't have meant that much to be honest. When tinnitus is severe, habituation is absolutely nothing like reduction - from a physical and mental point view. I'd give everything in the world I own for a 50% reduction and I am a seasoned veteran with this, and know habituation (which is nothing more than living with it without being depressed or anxious) like the back of my hand.

Experiencing this like I have, I think something like Lenire can be a good option for those with mild tinnitus who keep having to run into a quiet room to check to see if it's there - but equally white noise through ear maskers would do the same job without the huge expense.

IMHO Lenire will do very little for many severe sufferers.

Everyone is entitled to their opinion from their experiences but statements like this, which can be found on many audiologist websites, not only show the lack of understanding of severe volume tinnitus, but why many with this condition feel very isolated and whose symptoms are very misunderstood.

 

[Pos]

Everyone is entitled to their opinion from their experiences but statements like this, which can be found on many audiologist websites, not only show the lack of understanding of severe volume tinnitus, but why many with this condition feel very isolated and whose symptoms are very misunderstood.

I fully agree with you. When tinnitus is severe, it is extremely difficult to habituate to it. However, if one does manage to habituate to it, then it is no different to someone habituating at a mild level. They have both habituated. I'm not discounting anyone. Severe tinnitus is ruthless and I personally couldn't fathom habituating to it when I was experiencing it. Purely because I was in total distress and it didn't seem possible at all. However, if a sufferer manages to habituate to severe tinnitus, then that is a success. It's just a hard thing to achieve when tinnitus is severe. Everyone is different and is capable of different things.

I see you said you would give everything you own to have a 50% reduction in volume. Well, what would you give to get a 50% gain in habituation? In both circumstances your quality of life has improved by 50%.

 

[RunningMan]

Not true at all. I have had tinnitus since birth and I have never known silence. I have had mild, moderate and severe forms. I have been habituated too for over four decades. I can tell you from a lot of years of experience that this statement is very wrong.

Habituation is much easier when the tinnitus is mild to moderate, non-reactive and maskable. I was habituated many, many years, and it never bothered me - a 50% volume reduction probably wouldn't have meant that much to be honest. When tinnitus is severe, habituation is absolutely nothing like reduction - from a physical and mental point view. I'd give everything in the world I own for a 50% reduction and I am a seasoned veteran with this, and know habituation (which is nothing more than living with it without being depressed or anxious) like the back of my hand.

Experiencing this like I have, I think something like Lenire can be a good option for those with mild tinnitus who keep having to run into a quiet room to check to see if it's there - but equally white noise through ear maskers would do the same job without the huge expense.

IMHO Lenire will do very little for many severe sufferers.

Everyone is entitled to their opinion from their experiences but statements like this, which can be found on many audiologist websites, not only show the lack of understanding of severe volume tinnitus, but why many with this condition feel very isolated and whose symptoms are very misunderstood.

Agreed. Habituation and tinnitus reduction are not the same thing, even if there is some correlation. 50% reduction is only 6 dB, so I would want more like 90% reduction for my severe tinnitus to be very happy, then I could habituate to the mild tinnitus that remains. But habituation is pretty much impossible as it is. I was habituated to mild tinnitus for 20+ years before it became severe.

 

[DeanD]

I fully agree with you. When tinnitus is severe, it is extremely difficult to habituate to it. However, if one does manage to habituate to it, then it is no different to someone habituating at a mild level. They have both habituated. I'm not discounting anyone. Severe tinnitus is ruthless and I personally couldn't fathom habituating to it when I was experiencing it. Purely because I was in total distress and it didn't seem possible at all. However, if a sufferer manages to habituate to severe tinnitus, then that is a success. It's just a hard thing to achieve when tinnitus is severe. Everyone is different and is capable of different things.

No, habituating isn't a one-size-fits-all, just like tinnitus isn't. Habituation is a terrible word too.

You can be fully habituated, meaning you don't hear or think about it (as it's mild), or hear it everywhere (severe) but try and push past it to have some resemblance of a life. These are not the same thing.

In mild cases you go out and don't hear it, in severe cases you do. Throw reactiveness in to the mix where just going out will make it worse - well, who wouldn't have a mentally hard time with that.

Just because both mild and severe sufferers have decided to get on with life, it doesn't mean both suffer equally.

In terms of %, there are a lot more habituated mild sufferers than there are severe sufferers - and that's the difference.

I have read over 1000 case studies on here, but not sure I read any severe reactive sufferers who have fully habituated and get on with life happy without thinking about it. On the contrary, there are millions of mild sufferers who can.

I think you're talking about a theory that does not translate well to reality.

I see you said you would give everything you own to have a 50% reduction in volume. Well, what would you give to get a 50% gain in habituation? In both circumstances your quality of life has improved by 50%.

Not the same thing by any standards. I would take a 50% reduction any day of the week. These are not the same things and not the same gains.

 

[Pos]

Not the same thing by any standards. I would take a 50% reduction any day of the week. These are not the same things and not the same gains.

I disagree because people who have fully habituated are no longer bothered if they get their tinnitus reduced/cured. Each to their own though

 

[DeanD]

I disagree because people who have fully habituated are no longer bothered if they get their tinnitus reduced/cured. Each to their own though

I disagree because it is statements like this that cause the biggest frustration for severe sufferers. Very limited understanding, and lumping tinnitus and habituation as if everyone is the same.

Find me an example of a severe reactive sufferer no long longer bothered by their tinnitus and living a perfectly happy life with no TV, no music, limited travel, social isolation, etc... and I and other real severe sufferers may start to see your point.

 

[Jammer]

There was an interesting article in the Washington Post today about Lenire and the Shore device. It basically said Lenire works for some and the Shore device is similar to Lenire and is waiting for FDA approval.

 

[Alberte]

There was an interesting article in the Washington Post today about Lenire and the Shore device. It basically said Lenire works for some and the Shore device is similar to Lenire and is waiting for FDA approval.

Interesting! Thank you for sharing this article with us.

 

[AverageJoe12]

There was an interesting article in the Washington Post today about Lenire and the Shore device. It basically said Lenire works for some and the Shore device is similar to Lenire and is waiting for FDA approval.

PDF attached for anyone who would like to read it. This doesn't include the interactive widgets that were part of the story or some of the graphics formatted properly, but the text is all there.

Whether this is our panacea or not, publicity is a good thing.

 

[Nick47]

I disagree because people who have fully habituated are no longer bothered if they get their tinnitus reduced/cured. Each to their own though

No my friend. You clearly do not understand. Ridiculous.

 

[Arrojo]

There was an interesting article in the Washington Post today about Lenire and the Shore device. It basically said Lenire works for some and the Shore device is similar to Lenire and is waiting for FDA approval.

I'm confused. How is this any different from what's been discussed in this entire thread? Also, it seems very expensive if it "only works for some."

 

[RunningMan]

I'm confused. How is this any different from what's been discussed in this entire thread? Also, it seems very expensive if it "only works for some."

Yes, it's certainly expensive, but at least some will experience an improvement using Lenire due to the placebo effect, so they will consider it money well spent. That might be worth it to some people, not me. So, hopefully Auricle pans out, which showed some real improvement vs. a placebo.

 

[Pos]

Yes, it's certainly expensive, but at least some will experience an improvement using Lenire due to the placebo effect, so they will consider it money well spent. That might be worth it to some people, not me. So, hopefully Auricle pans out, which showed some real improvement vs. a placebo.

Auricle is really no different to Lenire. Both are bimodal stimulation. I am lost as to how you have managed to convince yourself that Lenire is just a placebo effect.

 

[RunningMan]

Auricle is really no different to Lenire. Both are bimodal stimulation. I am lost as to how you have managed to convince yourself that Lenire is just a placebo effect.

No different? Both being bimodal does not make them the same. The effectiveness of one vs. the other can be very different because of the differences in how the electrical stimulus is applied and the timing with the sounds. You could make your own bimodal device, and that doesn't mean it will work as well as the Auricle device. It doesn't make it the same.

I didn't say Lenire is a placebo effect. I said that at least some will experience an improvement using Lenire due to the placebo effect. One study showed 20% to 25% responded positively to the sound stimulus alone in the placebo/control arm of a bimodal treatment study. I recommend reading this entire thread. You can read the user reviews about the Lenire device in this thread:

Lenire — User Experiences and Reviews

You can read about the Dr. Shore / Auricle device in this thread:

New University of Michigan Tinnitus Discovery — Signal Timing

 

[Kleiner]

Lenire uses a Bluetooth system, which is a disaster for a system where the timing must be precise to a millisecond range. This unnecessarily complicated design makes Lenire closer to a teleshopping gadget than a medical device.

Comparing Lenire with real bimodal treatment devices makes no sense.

 

[gameover]

Lenire uses a Bluetooth system, which is a disaster for a system where the timing must be precise to a millisecond range. This unnecessarily complicated design makes Lenire closer to a teleshopping gadget than a medical device.

Comparing Lenire with real bimodal treatment devices makes no sense.

A researcher here thinks the timing precision is maybe not that critical: Tinnitus Models — Learn How Tinnitus Originates

 

[Supersix]

Lenire is designed to assist individuals with moderate tinnitus that has been present for a short duration. However, the audiologist in Beverly Hills is apprehensive about accepting patients like me and @RunningMan because he worries that we might complain about its performance. He is very selective about who he brings on. He has enough business to do that. I was on a Zoom call with him and 50 other people from ATA.

 

[Kleiner]

A researcher here thinks the timing precision is maybe not that critical: Tinnitus Models — Learn How Tinnitus Originates

In Dr. Shore's paper, timing is parameter #1.

Lenire is based on a different theory I know, but where Dr. Shore's papers are well constructed, Lenire's are enigmatic.

In my opinion, using a Bluetooth system in such sensitive device is an unnecessary source of complexity, to favor the commercial aspect.

 

[gameover]

In Dr. Shore's paper, timing is parameter #1.

Lenire is based on a different theory I know, but where Dr. Shore's papers are well constructed, Lenire's are enigmatic.

In my opinion, using a Bluetooth system in such sensitive device is an unnecessary source of complexity, to favor the commercial aspect.

I certainly hope you are right. I am not an expert but I agree choosing Bluetooth was idiotic, adding expense and complexity.

 

[AverageJoe12]

Lenire is designed to assist individuals with moderate tinnitus that has been present for a short duration. However, the audiologist in Beverly Hills is apprehensive about accepting patients like me and @RunningMan because he worries that we might complain about its performance. He is very selective about who he brings on. He has enough business to do that. I was on a Zoom call with him and 50 other people from ATA.

Did they say anything about hyperacusis patients (with tinnitus) and Lenire?

 

[Supersix]

Did they say anything about hyperacusis patients (with tinnitus) and Lenire?

I believe the doctor suggested treating hyperacusis before using Lenire to achieve better results.

 

[momus]

Not to be the voice of doom and gloom, but I'd like to have a dollar for every time I've read of some Dr. Somebody or other who had invented a new thingamajig that was going to provide relief for tinnitus. If it's not some device, it's a drug, or both. But the only thing I see that ever gets helped is that doctor's bank account. Face it, if any of this stuff worked, we would all be beating a path to their door.

If someone wants me to be a guinea pig for their invention, then they need to pay me, I'm not going to pay them.

 

[Jan64]

I am not an expert but I agree choosing Bluetooth was idiotic

Why? With Bluetooth you do not have to care about another wire (you already have one from the tongue tip to the device). I use Lenire and am happy with it!

 

[Jonno02]

Why? With Bluetooth you do not have to care about another wire (you already have one from the tongue tip to the device). I use Lenire and am happy with it!

Bluetooth suffers from audio latency up to 20x that of wired headphones. This can increase further depending on range and external factors such as interference from other devices.

Not great when your device requires precise timing.

 

[Tryn2BHopeful]

Why? With Bluetooth you do not have to care about another wire (you already have one from the tongue tip to the device). I use Lenire and am happy with it!

Bluetooth vs. Wired aside, you seem to have had tinnitus for a very long time. Do you feel it has helped you? Have you experienced a reduction in your tinnitus?