Lenire — Bimodal Stimulation Treatment by Neuromod

[InNeedOfHelp]

Does anyone know when Neuromod applied for FDA approval? Did it take a year or so for Lenire to be approved?

It took 1.5 years. The submission date was August 2021.

It has been categorized as De Novo class II device. One of the risks stated was an increase in tinnitus. Mitigation for this was clinical performance testing and labeling the device/warning. There was also a side effect of hearing loss due to overstimulation.

Just wow. I don't think the FDA knows the impact of a tinnitus increase on a human being.

Here is some information from the FDA directly on the De Novo classification for Lenire and the assessment and approval. Fun read.

https://www.accessdata.fda.gov/cdrh_docs/pdf21/DEN210033.pdf

 

[DeanD]

@DeanD, did you have a consultation with Dr. De Ridder?

Yes I did. I was at the Brai3n Institute. I had an EEG done. I met with Jan Oost whilst there, and then a follow-up appointment with Dr. De Ridder.

That's interesting about tDCS, although we have no data on this

This 30% number was given to me by Dr. De Ridder during the consultation on tDCS treatment.

I don't know if this is published anywhere.

 

[Nick47]

Yes I did. I was at the Brai3n Institute. I had an EEG done. I met with Jan Oost whilst there, and then a follow-up appointment with Dr. De Ridder.

This 30% number was given to me by Dr. De Ridder during the consultation on tDCS treatment.

I don't know if this is published anywhere.

Thanks @DeanD. Did you try Dr. De Ridder's medicine cocktail? I'm having problems getting it dispensed.

 

[DeanD]

Thanks @DeanD. Did you try Dr. De Ridder's medicine cocktail? I'm having problems getting it dispensed.

No I haven't.

I haven't had the greatest success with standard anxiety and depression medication, so I was worried about more brain changing chemicals.

It was in part what put me off of tDCS - although Dr. De Ridder did say he rarely, if at all, sees patients get worse through the treatment.

 

[AnthonyMcDonald]

I appreciate the reply! That kind of money sure would be an issue in these times for a glimmer of improvement. Shame, I got so excited when I found out they specialise in tinnitus and they're so close to me.

In my personal opinion, based on research and scientific evidence, Lenire is a scam and should not be used by anyone.

 

[Nick47]

No I haven't.

I haven't had the greatest success with standard anxiety and depression medication, so I was worried about more brain changing chemicals.

It was in part what put me off of tDCS - although Dr. De Ridder did say he rarely, if at all, sees patients get worse through the treatment.

@DeanD, it seems a bit pointless to have an EEG and then no treatment? He doesn't use standard antidepressant or anxiety medication. He actually warns against this.

 

[Jonno02]

Does anyone know when Neuromod applied for FDA approval? Did it take a year or so for Lenire to be approved?

That's down to Neuromod.

The FDA start a 6-month clock when you submit your application. When they respond to ask for more data/questions the clock stops. That means Neuromod took quite a while to respond or provide them with the necessary data.

 

[DeanD]

@DeanD, it seems a bit pointless to have an EEG and then no treatment? He doesn't use standard antidepressant or anxiety medication. He actually warns against this.

The intention was to go through with the tDCS at the time, and I had travelled all the way to Belgium for it.

I was perhaps a little underwhelmed on how effective the treatment was being put forward - plus I had a worsening two weeks after returning to the UK, plus all manner of other symptoms, which set me back.

Certainly no pushy sales tactics there, if anything more an admission that results can only make small improvements at best.

And yes I know what you mean, but since onset of all of this, I have struggled with sleeping tablets too, which I never did before.

It has made me very cautious about any medication that can affect the brain.

I still have the option.

 

[EDDTEKK]

Lenire doesn't work. Save your money for Dr. Shore's device. As Dr. De Ridder said in his latest video, Lenire doesn't help to reduce tinnitus loudness, which means, it has no relevancy treating tinnitus.

The FDA approval for Lenire will at least hopefully help to speed up the approval process for Dr. Shore's device.

 

[DaveFromChicago]

Lenire doesn't work. Save your money for Dr. Shore's device. As Dr. De Ridder said in his latest video, Lenire doesn't help to reduce tinnitus loudness, which means, it has no relevancy treating tinnitus.

The FDA approval for Lenire will at least hopefully help to speed up the approval process for Dr. Shore's device.

As I quoted before:

"The Brand New Treatment Lenire
Was Supposed To Silence The Ear;
It Was Great In Theory
But Made Us Quite Leery
When Failures Were Posted On Here."

Very insightful comment about how FDA approval of Lenire should open every fast track for the same approval being granted for Auricle (Dr. Shore).

In fact, this is the only benefit (however unintended) that, as far as I am concerned, I see in the FDA's approval of Lenire.

Come on, if this Mattel Toy can get approval with all sorts of fallback alibis known as "THI" improvements, then Dr. Shore's professional and defensible data presentation should take a matter of days.

 

[BTaylor12]

Anyone know why the University of Minnesota is recruiting for a clinical trial on Lenire, despite it being FDA approved?

I was considering joining the trial, just to be able to try it sooner.

 

[Amv]

Anyone know why the University of Minnesota is recruiting for a clinical trial on Lenire, despite it being FDA approved?

I was considering joining the trial, just to be able to try it sooner.

Hey @BTaylor12. Hubert Lim is Chief Scientist Officer of Neuromod (Lenire) and also Professor of Biomedical Engineering and Otolaryngology at University of Minnesota. So there is a link between both parties.

 

[Alberte]

Anyone know why the University of Minnesota is recruiting for a clinical trial on Lenire, despite it being FDA approved?

Why are they doing another clinical trial?

 

[BTaylor12]

Why are they doing another clinical trial?

I inquired about enrolling, and they are ready to give me the date for the first appointment.

I'm hesitant because I'm 1500 miles away from Minneapolis lol.

 

[jeremy3s]

Anyone know why the University of Minnesota is recruiting for a clinical trial on Lenire, despite it being FDA approved?

I was considering joining the trial, just to be able to try it sooner.

Do you have a link for the clinical trial? I'd like to get in on this.

 

[T Toledo OH]

Do you have a link for the clinical trial? I'd like to get in on this.

I would like a link too. How do we sign up?

 

[Stuart-T]

Neuromod got approval for Lenire in the US market:

Irish firm's tinnitus treatment approved for US market

The reason it got approval is not because it is effective - but because it is harmless. Still scandalous that Neuromod will sell this as proof their rubbish Lenire works.

 

[CDNThailand]

I discovered today that Lenire is sold in my city. I had a chat with the audiologist and he said they have treated 25 persons over the course of 2 years with only 1 that didn't have some kind of improvement.

is this worth a try? It's gonna be around 3.000€.

How do you know your "audiologist" is not scamming/lying to you? Because I'd say there's a 90% chance he is!

 

[Ctjbush]

Please tell me: How in the world does a product such as Lenire get FDA approval if it doesn't work?

 

[Stuart-T]

Please tell me: How in the world does a product such as Lenire get FDA approval if it doesn't work?

As I previously pointed out, Neuromod submitted their research (funded and carried out by themselves), it ticked th FDA boxes, they paid their fee - and the FDA judged that Lenire is actually not a danger to use; nobody is going to blame the FDA for getting killed or brain damage by Lenire because it just has no capability to do anything like that. So it passed. That does not mean it works.

As for audiologists claiming 90%+ efficacy, no idea why they would claim that and, based on feedback I have seen, it looks more like 1 in 3 claim some success - exactly in line with the placebo response.

There are cheaper white noise generators out there.

 

[KoolKat]

And the worst part about it is that now the brain dead audiologists and doctors will push Lenire on us. Which I guess is better than the typical learn to live with it.

 

[Samwise_The_Loud]

As someone who had their tinnitus get worse due to Lenire, the fact it's getting approved in the USA is very worrying. Thousands of vulnerable people are going to have a bad time. I only purchased it because I was desperate and distressed without proper knowledge of this condition.

 

[Joey72]

I read that Neuromod is currently training audiologists in the U.S. for Lenire, and they have a waiting list you can join. They will let you know when it becomes available near you. After hearing that it made tinnitus worse for some, I think I'll pass.

 

[Sironketchup]

I'm so desperate that I'm about to book a remote appointment to get my settings changed to maybe PS6.

I was on PS4 for over 2 years.

Has anyone tried PS6?

 

[AfroSnowman]

I'm so desperate that I'm about to book a remote appointment to get my settings changed to maybe PS6.

I was on PS4 for over 2 years.

Has anyone tried PS6?

Will they change the settings remotely?

 

[Sironketchup]

Will they change the settings remotely?

The appointment will be remote but I will need to send them my device to change the program.

All in all this will be 100€ for the appointment and the courier picking up my device.

 

[AfroSnowman]

The appointment will be remote but I will need to send them my device to change the program.

All in all this will be 100€ for the appointment and the courier picking up my device.

I'll check in with them. I'd give PS6 a chance for a $100.

 

[SarahMLFlemmer]

The appointment will be remote but I will need to send them my device to change the program.

All in all this will be 100€ for the appointment and the courier picking up my device.

You are using Lenire, correct? How is it helping you?

 

[Dizzyhead888]

What non-tinnitus related side effects does Lenire potentially have?

Has anyone experienced neuropathy from it, especially in the face?

 

[AfroSnowman]

What non-tinnitus related side effects does Lenire potentially have?

Has anyone experienced neuropathy from it, especially in the face?

I think there was one user on this thread that reported issues along those lines, but I forget who.