Lenire — Bimodal Stimulation Treatment by Neuromod

#5,732
Hello. I live in the U.S. and received my appointment date.

I was wondering if anyone can give some guidance about returning home with the device as it is not FDA approved. I've been reading about personal importation and it appears to meet the criteria.

Any advice? Thank you.
 
#5,734
Wfg3 said:
I was wondering if anyone can give some guidance about returning home with the device as it is not FDA approved. I've been reading about personal importation and it appears to meet the criteria.
Click to expand...
I've emailed the FDA about it and they just said even that way it will be up to whomever is evaluating the personal importation.

However, so far the only person who has got back to me on bringing it back to the US has told me they just put it in their carry on bag and that was it.

I'd like to hear if anyone has done the personal importation method and how it went.
 
#5,736
@ChrisBoyMonkey Thank you for your response. I'm a nervous wreck about this whole thing, but after a decade of this, I have to give it a shot.

Good luck with your appointment.

The carry on idea sounds like the path of least resistance. Anyone else from the U.S. making the journey?
 
#5,738
Wfg3 said:
@ChrisBoyMonkey Thank you for your response. I'm a nervous wreck about this whole thing, but after a decade of this, I have to give it a shot.

Good luck with your appointment.

The carry on idea sounds like the path of least resistance. Anyone else from the U.S. making the journey?
Click to expand...
Thank you. That's exactly the path I think I'm going to take since I'm in between medical coverage anyways lol.

They probably won't ask, airport security usually just wants to get people through as fast as possible so long as everyone is following the rules and don't have anything fishy. The device looks like a power bank so if they ask that's what is haha.
 
#5,739
I submitted my interest 14 days ago and got the initial robot response but haven't heard anything from Neuromod since. Should I reach out to Neuromod to check in? What has been the typical timeline of events after submitting interest?
 
#5,740
If you bring it back in your carry on... the issue is whether you should declare it to customs.

I wouldn't mention anything about it being a medical device...
Check the US Customs website for what to declare...

Maybe declare it as a $200 electric massager? Lol

I just signed up, late to the party...
 
#5,742
ChrisBoyMonkey said:
For peer review in general, it's not a vicious scrutinization or anything like that. It's more of a "I would've done this differently" kind of thing.
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Sorry but you are wrong here. The four possible outcomes of peer review are:
  • Accept as is
  • Minor revision
  • Major revision
  • Rejection
Rejection and major revision are very much a possibility and happen all the time. Do you have information to the contrary or is there something specific you know on Lenire that we don't?
 
#5,744
Chinmoku said:
Sorry but you are wrong here. The four possible outcomes of peer review are:
  • Accept as is
  • Minor revision
  • Major revision
  • Rejection
Rejection and major revision are very much a possibility and happen all the time. Do you have information to the contrary or is there something specific you know on Lenire that we don't?
Click to expand...
The latter two are on the table, but they're far from likely, considering the science is sound and being peer reviewed by researchers who believe in the science as it is.
 
#5,745
threefirefour said:
The latter two are on the table, but they're far from likely, considering the science is sound and being peer reviewed by researchers who believe in the science as it is.
Click to expand...
That's reassuring, although I'm not sure how we can be certain of that? Peer review is blind. Do you mean to say that most scientists in the area are in line with the theory? I understand having Hubert Lim onboard will make acceptance easier but we don't know who the reviewers are.

Also to @ChrisBoyMonkey, I hope you are right and this is minor revision or accepted. Trying to stay positive.
 
#5,746
Chinmoku said:
Sorry but you are wrong here. The four possible outcomes of peer review are:
  • Accept as is
  • Minor revision
  • Major revision
  • Rejection
Rejection and major revision are very much a possibility and happen all the time. Do you have information to the contrary or is there something specific you know on Lenire that we don't?
Click to expand...
You can read a little more about peer review in general in this relatively short but useful article. As @threefirefour has said, the last one is the least likely to happen unless the conclusions and data really are way off, which isn't likely here.

Many of the world's leading tinnitus researchers have invested much time and research into this, including Dr. Hubert Lim. Even that researcher I'm in contact with seems to understand that this method is a little different but further advanced than his. For all I know he may even be part of the peer review, there aren't that many researchers in tinnitus. It seems most of the biggest ones are already working with Neuromod one way or another.
 
#5,747
threefirefour said:
The latter two are on the table, but they're far from likely
Click to expand...
It is more than unlikely, for a study that took this long, for as much money as they spent on it, for the names they brought in to manage the study, while not unheard of to have a study completely fail to be published, it would be really rare and career damaging for the researchers involved.
 
#5,748
AfroSnowman said:
It is more than unlikely, for a study that took this long, for as much money as they spent on it, for the names they brought in to manage the study, while not unheard of to have a study completely fail to be published, it would be really rare and career damaging for the researchers involved.
Click to expand...
I'm pretty sure that rejection is extremely unlikely here. For research that is honest, it's not a grilling.
 
#5,749
ChrisBoyMonkey said:
Just a heads up, I've been in contact with a researcher doing a different trial but is well aware of Lenire. He says he was at the presentation Dr. Lim gave in February and it looked very promising.

For peer review in general, it's not a vicious scrutinization or anything like that. It's more of a "I would've done this differently" kind of thing.

I really don't think it's a huge deal they commercialized before peer review, honestly it benefits us for being able to be treated faster. It's a tiny company, they need money, and we need treatment.
Click to expand...
It would be cool to apply that same philosophy to FX-322.
 
#5,750
JohnAdams said:
As far as I am concerned these trial results are invalid because one of the principal investigators WORKS FOR THE COMPANY MAKING THE DEVICE.
Click to expand...
I have spent the last two years of my life campaigning around conflicts of interest in medicine - these are rife, often damaging and hugely underdiscussed. See this from Newsnight just the other day - https://www.bbc.co.uk/news/health-50715156

However, even I would say it's probably unavoidable to have a trial author with a conflict in this situation - if we let small companies do trials for new products like this. It has to be declared very clearly on the paper. The only alternative system proposed is for governments to perform many more clinical trials on behalf of companies funded by tax on the companies. Where COIs really get dirty IMHO is with large very rich powerful companies like J and J, Medtronic, who pay doctors to act as ostensibly reasonably netural scientists on trials of their products, pay ghostwriting companies to write the actual papers, doctors taking money from the big companies end up on the boards who write the guidelines as to which treatments should be used etc. The companies do stuff like seed the literature with review papers by doctors they are paying saying there is a need for treatment for the condition their new product is for. I hate it, it's a subversion of science. COI declaration was mandated in the USA via the Sunshine Act, but in the UK, Ireland, most western countries there's no mandatory COI declaration so some of it gets hidden. Interestingly the US Sunshine act showed COIs were not always getting declared in papers by doctors. Also patients see doctors in clinic not realising their doctor is majorly on the take from the company making the drug or device the doctor is recommending that patient.

Bit off topic but it's SUCH an important subject in medicine. Yes Neuromod being the authors of this trial is a big COI, and yes I for one would trust the data much more if we had some system where companies had to pay the govt. to do trials like this for them. But - at least the COI is all out in the open with this small company and product, and at least Neuromod don't have the money to try to influence clinical guidelines, employ loads of doctors etc to push their product.
 
#5,751
ChrisBoyMonkey said:
For research that is honest, it's not a grilling
Click to expand...
From my now very dated experience with academic publications it is actually a bit of a grilling. It can be very nit picky, but if you did the research in a thoughtful professional manner it is just a matter of explaining deficiencies you didn't address, running different statistical analyses on the data you collected, and maybe some narrative work. In short unless there was gross professional negligence on the part of the researchers, they just rework the paper and maybe the analysis to get published. Unless there is a profound flaw in what they were doing the data sooner or later will find the light of day.
 
#5,752
Agrajag364 said:
I have spent the last two years of my life campaigning around conflicts of interest in medicine - these are rife, often damaging and hugely underdiscussed. See this from Newsnight just the other day - https://www.bbc.co.uk/news/health-50715156

However, even I would say it's probably unavoidable to have a trial author with a conflict in this situation - if we let small companies do trials for new products like this. It has to be declared very clearly on the paper. The only alternative system proposed is for governments to perform many more clinical trials on behalf of companies funded by tax on the companies. Where COIs really get dirty IMHO is with large very rich powerful companies like J and J, Medtronic, who pay doctors to act as ostensibly reasonably netural scientists on trials of their products, pay ghostwriting companies to write the actual papers, doctors taking money from the big companies end up on the boards who write the guidelines as to which treatments should be used etc. The companies do stuff like seed the literature with review papers by doctors they are paying saying there is a need for treatment for the condition their new product is for. I hate it, it's a subversion of science. COI declaration was mandated in the USA via the Sunshine Act, but in the UK, Ireland, most western countries there's no mandatory COI declaration so some of it gets hidden. Interestingly the US Sunshine act showed COIs were not always getting declared in papers by doctors. Also patients see doctors in clinic not realising their doctor is majorly on the take from the company making the drug or device the doctor is recommending that patient.

Bit off topic but it's SUCH an important subject in medicine. Yes Neuromod being the authors of this trial is a big COI, and yes I for one would trust the data much more if we had some system where companies had to pay the govt. to do trials like this for them. But - at least the COI is all out in the open with this small company and product, and at least Neuromod don't have the money to try to influence clinical guidelines, employ loads of doctors etc to push their product.
Click to expand...
Regardless of this conflict, there are some users on this site that I trust that are either using the device or about to and I trust them. I am still weary though because the person in question is also involved in some real publications that do nothing to help advance the science behind this condition.
 
#5,753
It's getting serious for me now. Today I got an appointment date for end of April in Dublin.

A few days ago I wrote them a reminder. When they answered they also gave me an e-mail and postal address for Hannover. And they also said they have no influence on the assessment fees in Germany.
 
#5,754
Chinmoku said:
That's reassuring, although I'm not sure how we can be certain of that? Peer review is blind. Do you mean to say that most scientists in the area are in line with the theory? I understand having Hubert Lim onboard will make acceptance easier but we don't know who the reviewers are.

Also to @ChrisBoyMonkey, I hope you are right and this is minor revision or accepted. Trying to stay positive.
Click to expand...
Ideally, it should. But peer research is done by people who are knowledgeable in the field, and for tinnitus bimodal stimulation it's a very small field. Neuromod said they know for a fact Dr. Susan Shore is peer reviewing their paper.
 
#5,758
I have a question that maybe someone can answer.

Can Lenire be used if I am taking benzos daily? Can it be less effective if you take this type of medication? Does anyone know?
 
#5,759
glacier said:
I submitted my interest 14 days ago and got the initial robot response but haven't heard anything from Neuromod since. Should I reach out to Neuromod to check in? What has been the typical timeline of events after submitting interest?
Click to expand...
I heard back from them about 2-3 weeks after I initially signed up. You should receive another automated email soon saying that they will contact you with an appointment date in January. As I see it, since they just handed out appointments for those who signed up in June/July/August from January to May, we will probably get our appointments not until May-June unfortunately, unless there are any cancellations.

I did read in this thread that they have a location in Germany that is now taking appointments. That could be another option?
 

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