Lenire — Bimodal Stimulation Treatment by Neuromod

[Gb3]

Below is from the Brai3n clinic, one of the centers involved in the trial.

So, 6% of the population will find this effective.

Did they say what criteria the 10% meets? That would be helpful.

 

[Nick47]

Did they say what criteria the 10% meets? That would be helpful.

No.

 

[Bhaveen]

No.

Well, I believe Brai3n was part of the TENT-A3 trials, so you would think they know what they're talking about. However, after looking at the trial eligibility criteria, nothing really stands out that would suggest 90% of the tinnitus population wouldn't be eligible.

 

[Diz72]

I developed tinnitus in October 2023 and have tried various treatments, but like most of you, I haven't had any success.

My question is about the Lenire device. Has anyone here actually tried it, and if so, has it provided any real help in reducing your tinnitus?

This device is quite expensive, and insurance doesn't cover it, so I'm curious to hear about any results from people who have used it.

 

[dd314]

I developed tinnitus in October 2023 and have tried various treatments, but like most of you, I haven't had any success.

My question is about the Lenire device. Has anyone here actually tried it, and if so, has it provided any real help in reducing your tinnitus?

This device is quite expensive, and insurance doesn't cover it, so I'm curious to hear about any results from people who have used it.

There's a user experiences thread with 50+ reports. Most people say it's trash.

 

[Bhaveen]

Tinnitus worse after using Lenire? Same here! I spent $4,500 on the device and audiology services, plus an additional $500 on travel. After completing the full 84-hour protocol, the volume and intensity of my tinnitus actually worsened.

When I reached out to the Lenire provider to request an adjustment, they encouraged me to try the treatment again. I did, after a four-month break, but only lasted two weeks because I couldn't tolerate it.

I then asked about their clinical data, and they informed me that for my "mild to moderate tinnitus," the success rate was 57.7%. When I pointed out that this information wasn't shared with me at the time of purchase (last December), they claimed the data was only recently updated.

I strongly believe that Lenire and its authorized audiology practices need to be much more transparent about the following:

1. There is a significant risk that you may not see any improvement.
2. There is no recourse if the treatment doesn't work for you.
3. Lenire will not accept returned devices, even though they could refurbish them and sell them at a lower price.

Buyer beware!

Thanks for sharing your experience and warning others. I'm sorry to hear about your situation, but 57.7 percent? That's unbelievable! Their materials mention success rates in the high 80s!

I've seen other posts where people have been encouraged to report adverse events to the FDA. I know it's a long shot, but if more complaints start coming in, you'd hope the FDA would step in and take action. This could force Lenire to either improve or, at the very least, add a warning to their device, acknowledging the risk of making the condition permanently worse. Right now, they only mention temporary spikes, which isn't good enough. They're getting away with it, and it's wrong.

 

[Lurius]

Tinnitus worse after using Lenire? Same here! I spent $4,500 on the device and audiology services, plus an additional $500 on travel. After completing the full 84-hour protocol, the volume and intensity of my tinnitus actually worsened.

When I reached out to the Lenire provider to request an adjustment, they encouraged me to try the treatment again. I did, after a four-month break, but only lasted two weeks because I couldn't tolerate it.

I then asked about their clinical data, and they informed me that for my "mild to moderate tinnitus," the success rate was 57.7%. When I pointed out that this information wasn't shared with me at the time of purchase (last December), they claimed the data was only recently updated.

I strongly believe that Lenire and its authorized audiology practices need to be much more transparent about the following:

1. There is a significant risk that you may not see any improvement.
2. There is no recourse if the treatment doesn't work for you.
3. Lenire will not accept returned devices, even though they could refurbish them and sell them at a lower price.

Buyer beware!

Hey, could you tell me how you reached out to them? I know a different company took over to handle Lenire for Neuromod, but I've lost all contact information. Neuromod hasn't replied to my email, so I'm a little unsure how to reach them these days.

 

[Head Tone]

I just received my Lenire device on Friday, costing $5,500 USD out the door. I'm currently on my 6th treatment (2x per day) as I type this.

Before this, I tried 15 sessions of HBOT, 25 hours of LLLT, and 30 days of steroids. My tinnitus levels are 2 in the left ear and 5 in the right. Over the last 30 days, my hyperacusis has improved by 10 dB, though that improvement seems to have come with time.

 

[Dizzyhead888]

I purchased my Lenire device in December 2023 from Gatwick Audiology. Prince, the audiologist, was very nice and believed I was a good candidate for Lenire.

My Tinnitus Handicap Score is 76, and my tinnitus is bilateral. I have only a very slight hearing loss in my left ear, which has been stable for years.

My tinnitus started immediately after my first COVID-19 shot, which I was eager to get because I am clinically vulnerable.

Initially, my tinnitus increased dramatically after using the device. Prince advised me to start slowly, using it for 10 minutes a day. I was hopeful that my strong reaction to the device indicated I would be receptive to the treatment.

I gradually increased my usage and have been using the device twice a day, consistently, since March. Unfortunately, there has been no improvement at all.

Prince discussed my case with Lenire, and they took the device back to ensure it was working properly. During the three weeks it was away, my tinnitus gradually worsened (something I didn't think was possible). Upon receiving the device back, it has returned to the level it was at before. My initial Tinnitus Handicap Score was 76, and when I retook it last week (on September 24), it was 70. There has been no significant improvement, and I feel like my savings have been wasted.

I'm sorry to hear about your experience with Lenire.

Lenire caused me serious side effects as well. What did they tell you about whether the device is working properly or not? I imagine they wouldn't admit if it's malfunctioning, but they might offer you an alternative device.

I'm interested in hearing more about your experience, as I'm also awaiting the results of their investigation into my device.

 

[antonio77]

It saddens me to see so many unprincipled doctors taking advantage of the desperation of tinnitus sufferers just to make money. Lenire doesn't work, yet clinics everywhere are advertising it with claims of 80% or even 90% effectiveness. It seems no one is concerned about the lack of regulation or oversight on this, despite the strict regulations on other medical matters. Just yesterday, I came across the website of an ENT doctor in my country who has been scamming people for about 15 years with a supposed treatment that, according to him, cures tinnitus by 80% (an oddly common figure; success rates are often claimed to be around 80%). Even a very famous TV presenter visited this clinic and stated that, rather than finding relief, his condition worsened.

 

[RocketJSquirrel]

I finished my 12 weeks yesterday, and there has been no improvement. It might actually be worse.

I have one more appointment with an audiologist, but I'm considering canceling it because I don't see the point.

There might be one reason to visit the audiologist again. It's possible that your Lenire device is not properly calibrated to your hearing. You could ask the audiologist to re-test your hearing and adjust the settings on the Lenire accordingly. Considering the cost of the device, it's probably worth trying this before giving up.

 

[123td]

There might be one reason to visit the audiologist again. It's possible that your Lenire device is not properly calibrated to your hearing. You could ask the audiologist to re-test your hearing and adjust the settings on the Lenire accordingly. Considering the cost of the device, it's probably worth trying this before giving up.

You are right about that.

 

[Bob3382]

I stopped using the device months ago, after the recommended 12-week period, as it didn't provide any noticeable benefit for my tinnitus. For me, it was ultimately a disappointment. However, some people insist that Lenire has been a significant success for them. Purchasing this device is certainly a risk, and the manufacturers make it clear there are no guarantees. But when you're dealing with tinnitus, you're often willing to try anything!

I just wish there were a way to recover some of the £3,600 I spent on it—it might work wonders for someone else. I can't help but wonder how many other Lenire devices are sitting on shelves, gathering dust.

And they are such control freaks that they will not allow you to sell the device to someone else and have it recalibrated for the new user. You have to buy the device new, either directly from them or through an audiologist, who then tests and calibrates it specifically for you.

If they would ease up and allow people to resell their used devices, they might earn a better reputation.

 

[Funkmaster]

Lenire is sponsoring Tinnitus UK for Tinnitus Week. I hope they have made a substantial donation, but it is disappointing to see Tinnitus UK promoting a device that, at best, is ineffective for most people and, at worst, worsens symptoms for some.

 

[Cmspgran]

Neuromod Closes €10 Million Financing to Accelerate Commercialisation

/PRNewswire/ -- Neuromod Devices Ltd. (Neuromod), an Irish medical device company specialising in tinnitus, has successfully closed a €10 million equity...

www.prnewswire.com

Neuromod continues to profit from a device that consistently receives negative reviews, while the Susan Shore device sits gathering dust on a shelf. What a sad world we live in.

I cannot even use the VHS vs Betamax analogy because both of those actually worked.

 

[Joey72]

Neuromod Closes €10 Million Financing to Accelerate Commercialisation

/PRNewswire/ -- Neuromod Devices Ltd. (Neuromod), an Irish medical device company specialising in tinnitus, has successfully closed a €10 million equity...

www.prnewswire.com

Neuromod continues to profit from a device that consistently receives negative reviews, while the Susan Shore device sits gathering dust on a shelf. What a sad world we live in.

I cannot even use the VHS vs Betamax analogy because both of those actually worked.

Definitely living in a clown world.

 

[Ken219]

Lenire made my tinnitus worse.

It's steadily ramped up over 15 years to severe. Nothing masks it now and I'm at my wits' end.

Lenire was my latest hope. I returned the expensive headphones and device and received a full refund. I had to use Consumer Rights Act to have them finally agree.

Thank you for sharing your experience. How the Lenire device received FDA approval is a mystery to me.

 

[FellowSufferer]

Final Update (Sort of)

On Friday I attended my final appointment with Neuromod to follow up on my 12 weeks of treatment. As previously mentioned, my Tinnitus hasn't really changed since starting out with Neuromod but there has been a recorded increase in volume (around 6 dB). I strongly doubt this is to do with the treatment itself, more likely around a lot of stress and anxiousness building up for a big move across the world in a couple of days and some really tough chest infections I've been struggling to shift.

The final appointment is pretty text book, fill out some THI surveys, undergo a Minimum Masking Level test, have a good talk about progress and what's going to happen moving forward.

In terms of what happens now that my official 12 week program is over, Neuromod have adjusted my device and advised to keep using it. From the information they have on hand, they would actually categorize me as somebody who would see results fairly promptly but with tinnitus being so complex and unique to every person, it's nigh-on impossible to say why my tinnitus hasn't changed.

I did ask the question nobody really wants an answer to, in that "Is there a point where I need to cut my losses and accept the treatment isn't going to work?" - the short answer is no. Due to the nature of the treatment, the longer you can persist with it, the better.

As for support moving forward, Neuromod would usually schedule you in for a 12 month follow up to check on progress and how your tinnitus has been in the months following on from the treatment. Unfortunately, my circumstances mean I won't be anywhere near this side of the world so we have agreed to leave this open for now. Neuromod have also mentioned that they're available for phone calls and emails if there are any questions and that if I'd like my device updated / timings changed, they are more than happy to handle this via postal services.

Honestly, I've been a bit disheartened in the build up to the final appointment due to my tinnitus not really changing. I had gotten to a point where I was ready to call it a day and to move on as best I could but the final talks with Caroline have refreshed some of my optimism and added a bit more motivation to persist with treatment. Regardless of the outcome I can wholeheartedly say I do NOT regret committing to this treatment and sincerely believe Neuromod are currently the best chance many of us have at getting some relief. Their commitment to their patients and willingness to accommodate changing needs or scenarios has been second to none, I still think the money was well spent - even on an educational stand point.

I'll try and update again in around 6 months, as long as I stay committed to the treatment.

Some additional content from questions and discussions;
- Neuromod have seen an extremely low number of people not responding within the 12 week window. Further to this, some of those people have gone on to see results after the 12 weeks with continued use of the device.
- They are currently trying to work on ways for users to update their devices from home via the use of a web portal, where possible.
- There are 10 treatment programs at this moment in time. However many of these are not used as Neuromod focus on the programs that led to the best response rates during the trials.

It's interesting to read these results from six years ago, where some people reported a big improvement while others saw no change. I know you haven't posted in five years, but has it improved at all recently, or is it still the same?