Lenire — Bimodal Stimulation Treatment by Neuromod

[Paulmanlike]

Fingers crossed @Paulmanlike. I'm already scoping out flight schedules and checking my email well... every 30 seconds.

Thank you for your insightful thoughts incidentally.

I see you on the Facebook pages of the BTA and AoHL, I hate seeing somebody suffer, I have as well but I'm a lot better.

What a feeling it's going to be once this malady is solved. I honestly think there's a good chance of it being solved in the coming years. Hey - even this bimodal neuromodulation is showing to decrease the volume so far!

 

[AliceW]

@annV,

Thanks for the good news!

Do you know if the person who was enrolled in the trial experienced good results?

Thank you.

 

[Allan1967]

I see you on the Facebook pages of the BTA and AoHL, I hate seeing somebody suffer, I have as well but I'm a lot better.

What a feeling it's going to be once this malady is solved. I honestly think there's a good chance of it being solved in the coming years. Hey - even this bimodal neuromodulation is showing to decrease the volume so far!

I think on social media/forums etc it can become quite easy to bear your soul and express the deepest darkest thoughts @Paulmanlike.

I suffer, but somehow I get through the day - hold a full time job; do my chores/tasks and I sleep relatively well at night provided I get my act the right way around and I just try to get on with it, plus I do have days of respite. The problems come for me when I've had nothing but shit day after shit day after shit day and it breaks you down. It's like someone singing 'I've got a song that'll get on your nerves' over and over... funny for moment, then just wears you down. Then tinnitus lets up for a day or two and you mentally regroup before the next wave.

I'm sure you'll know exactly where I'm coming from.

Anyway... let's hope we get news soon. It's the silence and the waiting, let's just get to the doing.

 

[Allan1967]

Article on BBC News about a trial for stroke victims here in Newcastle. Basically stimulation of the vagus nerve to create changes in the brain via electrical impulse implant... not related but shows this nerve stimulation business has people's interest.

 

[Arseny]

I wonder if people who started having visual snow after the onset of their tinnitus might have a chance in seeing improvements in their visual snow from using Lenire?

I had to get something even more rare than tinnitus!

I'm going to buy this device for the sole purpose of having a chance in reducing visual snow...

Also Visual Snow Initiative is planning to release their treatment this Summer.

 

[Hayls32]

I'd like to give it a shot, even if it only reduced my tinnitus a little bit, it would be worth the £.

Keeping my fingers and toes crossed.

 

[Jack Straw]

 

[KotaDomowa]

https://www.neuromoddevices.com/con...dvancement/phase-i-safety-and-feasibility.pdf

I tried to understand this document a few times. I can't - it is written in a scientific language (and my English is basic as well).

Based on my poor understanding, there is a bit about MML...

@Paulmanlike - could you explain the most important points of this publication to me? You are good at the summaries

[I know this is old information, but for some reason I keep coming back to it]

 

[Tanni]

I'm going to buy this device for the sole purpose of having a chance in reducing visual snow...

Also Visual Snow Initiative is planning to release their treatment this Summer.

The Visual Snow device apparently could help in the treatment of Tinnitus too.

https://www.neuromoddevices.com/con...dvancement/phase-i-safety-and-feasibility.pdf

I tried to understand this document a few times. I can't - it is written in a scientific language (and my English is basic as well).

Based on my poor understanding, there is a bit about MML...

@Paulmanlike - could you explain the most important points of this publication to me? You are good at the summaries

[I know this is old information, but for some reason I keep coming back to it]

Compliant patients (N 530) demonstrated statistically significant improvements in mean outcome measures after 10 weeks of treatment: THI (211.7 pts, p< 0.001), TLM (27.5dB, p < 0.001), and MML (29.7dB, p < 0.001).

 

[Paulmanlike]

https://www.neuromoddevices.com/con...dvancement/phase-i-safety-and-feasibility.pdf

I tried to understand this document a few times. I can't - it is written in a scientific language (and my English is basic as well).

Based on my poor understanding, there is a bit about MML...

@Paulmanlike - could you explain the most important points of this publication to me? You are good at the summaries

[I know this is old information, but for some reason I keep coming back to it]

You might as well wait for the new publications from the TENT-A1 (326 patient) and then TENT-A2 (172) paper as the protocol has all been redefined since then. I will be sure to break it down when it comes. Also, take a look at the presentation by Dr. Lim - it's a recording and a PowerPoint presentation that highlights the main findings and doesn't go into too much science-lingo.

 

[lcho]

https://www.neuromoddevices.com/con...dvancement/phase-i-safety-and-feasibility.pdf

I tried to understand this document a few times. I can't - it is written in a scientific language (and my English is basic as well).

Based on my poor understanding, there is a bit about MML...

@Paulmanlike - could you explain the most important points of this publication to me? You are good at the summaries

[I know this is old information, but for some reason I keep coming back to it]

In brief, these results show that for those who were compliant (those who completed at least 66% of the recommended 30 to 60 minute session every day for 10 weeks) achieved a reduction in TLM of 7.5dB, and an average reduction in MML of 9.7dB, after 10 weeks of use. These results were clinically significant, which is really quite promising given it was only for 10 weeks, and 66% is a low benchmark for compliance.

 

[GlennS]

Jack Straw, give it a rest with the memes already. If @annV's source is true it may be out within a month in Ireland.

 

[FGG]

I'm going to buy this device for the sole purpose of having a chance in reducing visual snow...

Also Visual Snow Initiative is planning to release their treatment this Summer.

Does Lenire work on visual snow, too?!?!

 

[Rio80]

Will people from the US be able to travel to Ireland to buy the device?

Sorry if this was already addressed but the thread is very long and I couldn't find anything about this in the last few pages...

 

[Heinrich_S7]

Will people from the US be able to travel to Ireland to buy the device?

Sorry if this was already addressed but the thread is very long and I couldn't find anything about this in the last few pages...

Ross O'Neill said US citizens can go to Ireland in the interview, but he said they didn't endorse it because you won't be under the care of a physician.

He also said they were aiming for a calendar year 2019 launch in North America, I'm hoping they can pull through with that.

 

[Rio80]

Ross O'Neill said US citizens can go to Ireland in the interview, but he said they didn't endorse it because you won't be under the care of a physician.

He also said they were aiming for a calendar year 2019 launch in North America, I'm hoping they can pull through with that.

Thanks for the reply.

Neuromod is very similar to the PoNS device treatment in that they're both targeting the somatosensory system via the tongue. However I can't figure out if their auditory simulations are the same. I'm aware Neuromod's is based on one's hearing loss and not on the levels of one's tinnitus. According to the case study below it says the PoNS device is paired with an auditory masking paradigm but it doesn't specify what it's based off of.

Perhaps someone more intelligent then me can read the case study stimulation description and perhaps infer from that to what the sounds are paired with? A lot of it is technical stuff that goes over my head.

https://www.tinnitustalk.com/attachments/tinnitus_suppression_using_translingual-pdf.24233/

 

[Autumnly]

Neuromod Broadens Senior Leadership Team in Preparation for Global Commercialisation of Lenire™ Tinnitus Treatment / May 08, 2019

• the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany
• Neuromod is investing in establishing the appropriate quality, regulatory and supply chain infrastructure to support near term European plans and lay the foundation for the Company's US strategy.
• Neuromod is delighted to announce the appointment of Deborah Arthur as Head of Quality and Regulatory Affairs, Suzanne O'Rourke as Director of Quality and Regulatory Affairs and Cathal Mc Fadden as Director of Operations. Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters.

 

[ajc]

Why does Neuromod keep pushing back the estimated Study Completion date for TENT-A1?

On May 8, 2018, they estimated the study would complete in December, 2018.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_4=View#StudyPageTop

Then they changed it...

On December 29, 2018, they estimated the study would complete in February, 2019.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_5=View#StudyPageTop

Then they changed it again...

On April 27, 2019, they estimated the study would complete in July, 2019.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_6=View#StudyPageTop

 

[RaZaH]

What about licking a battery while listening to Led Zeppelin?

 

[annV]

the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany

Who was it yesterday that told about it launching in June? WHO???

Her Majesty annV!

Next I'll provide information on the pricing

 

[Heinrich_S7]

Who was it yesterday that told about it launching in June? WHO???

Her Majesty annV!

Next I'll provide information on the pricing

Amazing annV! It seems your source was spot on.

Let us hope the FDA/Health Canada goes easy on them so they get clearance in North America soon! I'm certain they want to expand ASAP for revenue.

If this works, they are going to be very wealthy. They can have my money in my wallet!

 

[OnceUponaTime]

Nevertheless a reduction to moderate is pretty exciting and hopefully this is just the start of bimodal neuromodulation.

I would welcome this with open arms!

@annV
You ARE the Queen!
Thanks for the info Ann... I don't know how you do it!

 

[Don Tinny]

Neuromod Broadens Senior Leadership Team in Preparation for Global Commercialisation of Lenire™ Tinnitus Treatment / May 08, 2019

• the Company is now advancing towards initial commercialisation of its CE-marked product in Ireland and Germany
• Neuromod is investing in establishing the appropriate quality, regulatory and supply chain infrastructure to support near term European plans and lay the foundation for the Company's US strategy.
• Neuromod is delighted to announce the appointment of Deborah Arthur as Head of Quality and Regulatory Affairs, Suzanne O'Rourke as Director of Quality and Regulatory Affairs and Cathal Mc Fadden as Director of Operations. Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters.

I hope that "globally" includes Latin America.

 

[Agrajag364]

Why does Neuromod keep pushing back the estimated Study Completion date for TENT-A1?

On May 8, 2018, they estimated the study would complete in December, 2018.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_4=View#StudyPageTop

Then they changed it...

On December 29, 2018, they estimated the study would complete in February, 2019.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_5=View#StudyPageTop

Then they changed it again...

On April 27, 2019, they estimated the study would complete in July, 2019.

https://clinicaltrials.gov/ct2/history/NCT02669069?V_6=View#StudyPageTop

Haha that happens all the time with clinical trials. I think it's usually recruitment issues and then later analysis of the data that delays it.

 

[Agrajag364]

Who was it yesterday that told about it launching in June? WHO???

Her Majesty annV!

Next I'll provide information on the pricing

Yeah you do actually appear to be omniscient. But do you know the price of it yet because Tinnitus Talk hasn't forgotten the boob promise?

 

[GlennS]

Next I'll provide information on the pricing

That is of supreme importance to me, because...reasons.

 

[GlennS]

Neuromod Broadens Senior Leadership Team in Preparation for Global Commercialisation of Lenire™ Tinnitus Treatment

BTW, I just got a copy of this sent to me from their mailing list. So all this relentless criticism that Neuromod is holding us in some mysterious (and suspicious) "radio silence" purgatory should show a little more patience. (Of course, that won't happen... countdown to the next un-funny full-page Neuromod-bashing meme in 3, 2, 1...)

 

[spedgas]

Who was it yesterday that told about it launching in June? WHO???

Her Majesty annV!

Next I'll provide information on the pricing

I'm starting to think @annV is a secret Neuromod plant on this forum. She's been sent here to keep us on our toes and slowly divulge key information just for this website.

 

[Heinrich_S7]

BTW, I just got a copy of this sent to me from their mailing list. So all this relentless criticism that Neuromod is holding us in some mysterious (and suspicious) "radio silence" purgatory should show a little more patience. (Of course, that won't happen... countdown to the next un-funny full-page Neuromod-bashing meme in 3, 2, 1...)

Indeed, even though it's only launching in Germany and Ireland first, we will get to see bimodal stimulation's effects in the wild and not in a controlled arm setting with variable controlled parameters. I'm very excited and I expect to see tons of new posts on the forum, with hopefully many success stories!

If this works, I hope it goes global ASAP, tinnitus needs its first real treatment!

 

[Tanni]

Oh no, it's coming. Time to panic about what I'll do if it doesn't work for me!