Lenire: Retrospective Chart Review Demonstrating Effectiveness of Bimodal Neuromodulation for Tinnitus Treatment in a Clinical Setting

[SafeMusicFan]

Published 2 days ago: Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting

This is basically about Lenire. The conclusion from the article was: "These findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting."

To be honest, I am a bit suspicious of articles like this. From what I understand, Lenire has not been shown to be a consistently reliable or effective option in many cases, yet articles like this seem to suggest otherwise.

What I find more frustrating is that some news outlets report these findings with headlines like "New device offers relief to tinnitus sufferers." I am not particularly a fan of presenting the idea to the general public that this means we already have a "cure."

I am not sure what to make of it, but I wanted to share this anyway. If this thread is misplaced or redundant, I apologize.

 

[Jammer]

Advertisements disguised as news always suggest to me, at least, that selling a $4000 device without insurance coverage is difficult, and misdirection is necessary to meet their sales goals.

And what happens after you finish the 11-week course? I suspect they would lose many customers (not patients) if they offered a $400 per week treatment plan that failed to show meaningful results by the halfway point.

 

[Ken219]

Published 2 days ago: Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting

This is basically about Lenire. The conclusion from the article was: "These findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting."

To be honest, I am a bit suspicious of articles like this. From what I understand, Lenire has not been shown to be a consistently reliable or effective option in many cases, yet articles like this seem to suggest otherwise.

What I find more frustrating is that some news outlets report these findings with headlines like "New device offers relief to tinnitus sufferers." I am not particularly a fan of presenting the idea to the general public that this means we already have a "cure."

I am not sure what to make of it, but I wanted to share this anyway. If this thread is misplaced or redundant, I apologize.

I believe you are right to be suspicious. Thank you for expressing what most people feel.

 

[UHPTS]

Reading articles like this makes my blood boil. Not because of losing money on this useless device, but as you pointed out, it may look like we have a functional treatment.

These people do such a disservice to tinnitus sufferers.

 

[Fra]

It seems they did not measure subjective tinnitus loudness in decibels. That would probably have made the results more convincing. Still, we continue to face the problem of having no reliable biomarkers. Hopefully, the brain measurement tool being developed in Australia will become operational and widely available, which could improve the quality of this kind of research.

 

[UHPTS]

One of the reasons I did not believe Lenire could work was its use of Bluetooth to transfer sound to the headphones. Before AI, I struggled to find a definitive answer on whether Bluetooth can be synchronized with TENS electric pulses down to the millisecond, but I was fairly certain it could not.

I tried asking multiple AIs this question in different ways, and I always received the same answer: "Due to various factors, it is not possible to synchronize Bluetooth with TENS down to the millisecond."

The Bluetooth module inside the Lenire device is the same type sold on AliExpress for about a dollar. So it is not anything special, despite what the AI responses suggested.

Question to AI (Gemini):

If I needed to sync preciselly to 1 millisecond audio with electrical TENs pulses and I decided to use Bluetooth to transfer audio to headphones. With wired connection this precise sync is not an issue but would I be able to do it with BT?

AI answer:

Conclusion:

For precise, 1-millisecond synchronization between audio and TENS pulses, Bluetooth is not a reliable technology due to its inherent latency and variability. A wired connection is the far superior and practically necessary approach.

If you absolutely must use a wireless solution, you would need to invest in highly specialized hardware and software, and even then, achieving consistent millisecond-level synchronization would be extremely difficult and likely unreliable in real-world conditions. You should carefully evaluate the criticality of the synchronization and strongly consider the limitations of Bluetooth.

 

[Fightthearmy]

There should be a 'scam treatments' subforum for stuff like Lenire.

 

[msusser]

I purchased a Lenire in 2023. I followed the recommended treatment prescribed by the audiologist, and since that had no effect, I also tried alternative approaches, such as shortening the duration of use. That also did nothing for me.

For $4,000, I expected more than nothing.

 

[gracepixie]

I'll take the unpopular side of advocating for Lenire. It didn't make my tinnitus quieter, but it has helped my mind deprioritize it.

Before Lenire, it seemed like my tinnitus would get louder whenever I concentrated, had a conversation, or became interested in something. Shortly after starting Lenire, I noticed that my tinnitus would shift into the background during conversations, which was incredibly important to me.

It is true that the technology is rudimentary, but it still made a big difference for me. I began using it about three months after my sudden hearing loss, so I was still in the early phase—likely making me an ideal candidate.

That being said, I'm still annoyed by my tinnitus and continue to look for ways to get rid of it.

 

[RODRIGO]

I'll take the unpopular side of advocating for Lenire. It didn't make my tinnitus quieter, but it has helped my mind deprioritize it.

Before Lenire, it seemed like my tinnitus would get louder whenever I concentrated, had a conversation, or became interested in something. Shortly after starting Lenire, I noticed that my tinnitus would shift into the background during conversations, which was incredibly important to me.

It is true that the technology is rudimentary, but it still made a big difference for me. I began using it about three months after my sudden hearing loss, so I was still in the early phase—likely making me an ideal candidate.

That being said, I'm still annoyed by my tinnitus and continue to look for ways to get rid of it.

It was the same for me.

 

[Jammer]

Worth $4K? Was the relief durable, @gracepixie, @RODRIGO?

 

[gracepixie]

Worth $4K? Was the relief durable, @gracepixie, @RODRIGO?

Yes, I haven't used Lenire in months, but I still feel my brain shift my tinnitus into the background when I start focusing on something else. It's still just as loud during quiet moments, though.

That said, I went to a conference this week, and my tinnitus wasn't on my mind nearly as much as it was during the conference I attended before starting Lenire. It hasn't solved everything, but I think it helped me reach a better place and stay there.

Honestly, it was probably worth the $4,000, considering how bad things were before Lenire and the fact that I'm now able to attend meetings.

 

[Cirq]

@Jammer, yes, the cost stopped me from trying Lenire. A well-known audiologist told me to get a referral from the VA. I got the referral, but then he told me that my insurance, or any insurance, would not cover it. I would also have to take yet another ear test for $550, an extensive one.

I was living in hope of trying Lenire. I begged a doctor to let me try it, but my voice fell on deaf ears. It was all about the money. She referred me back to the VA, but they do not have Lenire where I go. I had gotten hearing aids years earlier.

So, while deep in depression and without 5,000 dollars sitting around, I gave up on Lenire. I got used to my tinnitus, came out of depression, and got back to life. I did not have the expensive Lenire to help me—I did it on my own, for free. I had no choice, as I did not work for two years. There was no sympathy; people can be brutal. That is why I am here.

Lenire is not approved by the FDA, so in my opinion, there is no proof it works. To me, it is just an expensive placebo that you could replicate on your own—another way for audiologists to make money.

 

[Jammer]

@Jammer, yes, the cost stopped me from trying Lenire. A well-known audiologist told me to get a referral from the VA. I got the referral, but then he told me that my insurance, or any insurance, would not cover it. I would also have to take yet another ear test for $550, an extensive one.

I was living in hope of trying Lenire. I begged a doctor to let me try it, but my voice fell on deaf ears. It was all about the money. She referred me back to the VA, but they do not have Lenire where I go. I had gotten hearing aids years earlier.

So, while deep in depression and without 5,000 dollars sitting around, I gave up on Lenire. I got used to my tinnitus, came out of depression, and got back to life. I did not have the expensive Lenire to help me—I did it on my own, for free. I had no choice, as I did not work for two years. There was no sympathy; people can be brutal. That is why I am here.

Lenire is not approved by the FDA, so in my opinion, there is no proof it works. To me, it is just an expensive placebo that you could replicate on your own—another way for audiologists to make money.

@Cirq, those who are suffering the most often find out that the only thing that reduces is their wallet.

 

[Joeseph Stope]

@Jammer, yes, the cost stopped me from trying Lenire. A well-known audiologist told me to get a referral from the VA. I got the referral, but then he told me that my insurance, or any insurance, would not cover it. I would also have to take yet another ear test for $550, an extensive one.

I was living in hope of trying Lenire. I begged a doctor to let me try it, but my voice fell on deaf ears. It was all about the money. She referred me back to the VA, but they do not have Lenire where I go. I had gotten hearing aids years earlier.

So, while deep in depression and without 5,000 dollars sitting around, I gave up on Lenire. I got used to my tinnitus, came out of depression, and got back to life. I did not have the expensive Lenire to help me—I did it on my own, for free. I had no choice, as I did not work for two years. There was no sympathy; people can be brutal. That is why I am here.

Lenire is not approved by the FDA, so in my opinion, there is no proof it works. To me, it is just an expensive placebo that you could replicate on your own—another way for audiologists to make money.

Just curious, is there really no way for people who have completed their treatment with Lenire to put it up on eBay or Amazon and sell it second-hand? Excuse my ignorance.

I realize, of course, that you would need an audiologist who is well-versed in Lenire to calculate the necessary frequencies and explain how to use the device, but couldn't that be fairly simple to explain and share on the internet?

 

[Fightthearmy]

Lenire is not approved by the FDA

Are you sure about that?

 

[Cirq]

Are you sure about that?

It is, actually. Sorry, you may have Googled it like I did. I assumed it wasn't, since insurance won't cover it. My bad.

It was granted FDA approval through a De Novo pathway in March 2023.

I've been wrong more often than I've been right.

I'm not sure how that connects to insurance not covering it. What exactly is a De Novo grant? Someone else can Google it.