Lenire — Bimodal Stimulation Treatment by Neuromod

[Harley]

Legal issues and Lenire:
I wasn't sure if this topic got covered, but it seems to me that there could be problems for those living outside EU, coming in for a treatment.

Please correct me if I'm wrong, but it is my understanding, that if one declares upon entry at the customs, that he/she is bringing in a medical device which wasn't approved by the authorities inside their country of residence, it will get confiscated.

If one does not declare this device and gets caught, it will also get confiscated, along with a possible charge and a red flag, that will insure he/she now gets automatically searched every time when coming in from abroad.

Yes, I realize that this device looks like your average MP3 player of sorts, but sooner or later (after few people declare it), the custom agents will catch on and circulate a memo about a medical device bearing the name Lenire and the attempts to smuggle it inside.

Considering that one is required to go back and forth to Ireland with this device 3 times (not counting the assessment trip at which the device is not yet issued), it would take some luck to pull it off without being detected, especially after some questioning about the purpose of the trips and some people getting understandably nervous.

I would like to get some opinions on this issue from other members if possible, along with any corrections to my reasoning (which is based on mixture of life experience and educated guesses).

Thank you everyone for reading my post.

 

[F-u-T]

I would like to think Lim brought what he learnt there with him. Surely that was Neuromod's whole point in getting him on board?

I think Lim brought his knowledge but just as important to Neuromod is his credibility in the scientific industry. That will be valuable for a US launch and FDA approval.

 

[ChrisBoyMonkey]

Legal issues and Lenire:
I wasn't sure if this topic got covered, but it seems to me that there could be problems for those living outside EU, coming in for a treatment.

Please correct me if I'm wrong, but it is my understanding, that if one declares upon entry at the customs, that he/she is bringing in a medical device which wasn't approved by the authorities inside their country of residence, it will get confiscated.

If one does not declare this device and gets caught, it will also get confiscated, along with a possible charge and a red flag, that will insure he/she now gets automatically searched every time when coming in from abroad.

Yes, I realize that this device looks like your average MP3 player of sorts, but sooner or later (after few people declare it), the custom agents will catch on and circulate a memo about a medical device bearing the name Lenire and the attempts to smuggle it inside.

Considering that one is required to go back and forth to Ireland with this device 3 times (not counting the assessment trip at which the device is not yet issued), it would take some luck to pull it off without being detected, especially after some questioning about the purpose of the trips and some people getting understandably nervous.

I would like to get some opinions on this issue from other members if possible, along with any corrections to my reasoning (which is based on mixture of life experience and educated guesses).

Thank you everyone for reading my post.

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

The FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:

• Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); and
• Product is for the treatment of a serious condition ( Prescription Drug Products):
  • The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
  • There is no known commercialization or promotion of the product to persons residing in the U.S.
  • The product does not represent an unreasonable risk.
  • The consumer affirms in writing that the product is for personal use.
  • The quantity is generally not more than a three month supply and either:
    1. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
    2. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

Can I purchase or bring biological or medical device products from a foreign country to the U.S.?
The same criteria applies to biological products and medical devices as human drug products.


Source: https://www.fda.gov/industry/import-basics/personal-importation

 

[Flyingsheep]

You're going to fly from Hong Kong? Kudos to you if you are, that's commitment.

I was wrecked for a week and I flew from England.

I'm here for work for a while, not sure if I'll still be in Hong Kong when the time to be in Ireland comes around. But I did get wrecked flying here from the States. 20 hours of flying and 3 different planes. But I will still be willing to fly to Ireland from here if I have to.

 

[F-u-T]

the custom agents will catch on and circulate a memo about a medical device bearing the name Lenire and the attempts to smuggle it inside.

I don't think it is worth spending much time worrying about this. Lenire is a pair of headphones, MP3 player, and magic tongue tickler. I doubt customs is going to issue an APB for the few units that will be brought back to the US before it is available here. Now if you load up a backpack full of good ole Peruvian Flake and try to come back into the USA you may run into some problems.

 

[Shelly75]

Where can one find those testimonials? I had trouble finding them...

There are more testimonials on their YouTube channel.

 

[zhiyuan]

I am a grad student. Is there anyway to stay in Dublin for the whole period of treatment? I think I should try to find some international internship in Dublin but it seems there are not many opportunities.

 

[Agrajag364]

I certainly hope the waves of pessimism and naysaying are over so I can stop having to invoke this gif in sarcasm:

View attachment 30904

Please do try to remember that skeptical cynicism is much more normal for Brits and the Irish and some other Europeans as compared to Americans. I do understand it's annoying and unsettling when people criticise something that represents a great hope, but I don't think it's fair to swoop on anyone who says anything negative.

 

[Harley]

Are there any circumstances when I could purchase or bring an unapproved drug or device into the U.S.?

The FDA has guidance for personal importation of drug or device products. Below provides information regarding situations for which this might be allowed:

• Product is not for treatment of a serious condition and there is no known significant health risk (Over the Counter, OTC); and
• Product is for the treatment of a serious condition ( Prescription Drug Products):
  • The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
  • There is no known commercialization or promotion of the product to persons residing in the U.S.
  • The product does not represent an unreasonable risk.
  • The consumer affirms in writing that the product is for personal use.
  • The quantity is generally not more than a three month supply and either:
    1. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
    2. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.

Can I purchase or bring biological or medical device products from a foreign country to the U.S.?
The same criteria applies to biological products and medical devices as human drug products.


Source: https://www.fda.gov/industry/import-basics/personal-importation

Thank you for this info.

 

[LongWait]

I'm on the waiting list for Lenire, I had a response. Hopefully I will get an appointment that someone cancelled. I live in England.

 

[LongWait]

I was reading that Susan Shore's device targets the trigeminal nerve, the same as Lenire, but her device also targets two other nerves C1,C2 somatosensory. So it seems to be similar.

 

[TinMan2019]

A question to those who have already visited the Neuromod office.

I'm preparing to make my final travel arrangements (as in getting from the airport to the office).

Can I just rent / hire a car from Dublin airport or am I better off using other methods of transport such as a Uber or whatever public transport there is? Is there free parking? My preferred method would be to rent a car. However knowing European cities, sometimes this can be more of a hindrance. Thanks in advance. I promise to keep the community updated with every step of my progress.

Again best regards and good luck to all.

Just want to add another note. I do my best to keep off the forums, just because the more I read, the louder my tinnitus becomes... So excuse the low post quantity. I will however be updating my progress. Truth be told, knowing treatment is around the corner, I honestly find my tinnitus a lot less bothersome. So that's a positive right there. I hope it doesn't do a u-turn in that the treatment doesn't work, and puts me back in a place I was when I first got it.. I'm not a pessimist though, so staying very positive!

 

[Markku]

I will however be updating my progress.

I hope you have already signed up to our Lenire User Experience Group (see the banner at the top of the thread).

@PeterPan is the project manager (he, I and @Hazel just had a conference call today finalizing the details).

Being part of the group isn't very taxing at all, and you can do it while being off the forums (we'll email surveys to track your progress). In turn, you'll help the community and other potential patients wanting to try Lenire in the future.

It's also worth noting that your identity and personal information will not be revealed to anyone and we will protect your anonymity when publishing results from the group.

Best of luck to you.

 

[Candy]

There is an app called Free Now which is the Irish equivalent of Uber. It took us about 20 mins from and to the airport, quite close.

There was plenty of parking but not sure if it was free. The Neuromod Office is in this big clinic/hospital type facility.

There's a big cafe on site as well.

We wanted to avoid all stress so we got a cab using the app for our first visit. The city felt much smaller and less chaotic than London. We stayed at a hotel by the airport.

@TinMan2019

 

[Annpann]

There is an app called Free Now which is the Irish equivalent of Uber. It took us about 20 mins from and to the airport, quite close.

There was plenty of parking but not sure if it was free. The Neuromod Office is in this big clinic/hospital type facility.

There's a big cafe on site as well.

We wanted to avoid all stress so we got a cab using the app for our first visit. The city felt much smaller and less chaotic than London. We stayed at a hotel by the airport.

@TinMan2019

Could you please tell me what the taxi cost? I have my initial appointment in October.

 

[GlennS]

Legal issues and Lenire:
I wasn't sure if this topic got covered, but it seems to me that there could be problems for those living outside EU, coming in for a treatment.

You're not the first to raise this concern, and I suggest everyone just adopt a Fight Club mentality and keep these concerns to themselves so as not to create a self-fulfilling prophecy.

 

[Lurius]

It's funny, I just logged on to ask exactly those questions @Candy. Did you have to pay anything for the Uber? Was it very pricey? What was the name of the hotel? When do you go back to pick up your device? Sorry, I'm just very curious.

 

[Allan1967]

Hermitage Medical Centre.

 

[GlennS]

Hermitage Medical Centre.

Those bricks look familiar. If they were only yellow.

 

[Allan1967]

Those bricks look familiar. If they were only yellow.

View attachment 30938

It's actually a very nice building and grounds.

 

[Candy]

-Taxi was €32.
-We stayed at the Clayton Hotel near the airport (shuttle to take you there).
-Going back first week of August.

 

[Allan1967]

The 777 takes to a shopping centre called the Livery (I think) which is about a mile away. Can be done on foot.

 

[BobDigi]

I've recently read about the Neuromod Lenire device and it looks to me like another medical con people will laugh about in years to come. Of course I hope I'm wrong. But I think it's going to join the list of wobble machines and abs electric pulse exercise tools.

 

[Annpann]

I've recently read about the Neuromod Lenire device and it looks to me like another medical con people will laugh about in years to come. Of course I hope I'm wrong. But I think it's going to join the list of wobble machines and abs electric pulse exercise tools.

Time will tell. I am certainly prepared to give it a chance.

 

[Ruse]

I've recently read about the Neuromod Lenire device and it looks to me like another medical con people will laugh about in years to come. Of course I hope I'm wrong. But I think it's going to join the list of wobble machines and abs electric pulse exercise tools.

The difference between those and Bimodal Neuromodulation is that the latter is proven to work for its intended use through clinical trials.

The question now is more more geared towards how much improvement will we get rather than whether it works at all.

 

[BobDigi]

Time will tell. I am certainly prepared to give it a chance.

But that's what scams rely on. People prepared to pay money to "give it a go"! It seems like homeopathy-esque nonsense but I'd be glad to be wrong.

 

[ChrisBoyMonkey]

But that's what scams rely on. People prepared to pay money to "give it a go"! It seems like homeopathy-esque nonsense but I'd be glad to be wrong.

But scams don't have large costly clinical trials like Neuromod did. If it were a scam, there would be no way for them to make a Return On Investment because there would be no more income after the first wave; they would be knowingly wasting money into building scientific efficacy and infrastructure. Reputable university professors such as Dr. Hubert Lim would not be putting their reputations on the line with this company going into their payroll if it were a scam. A scam would never do this because a scam would never work that way, it would be a huge waste of the scammer's time and money. They would never profit. All the indications say this is not a scam.

 

[Ruse]

But that's what scams rely on. People prepared to pay money to "give it a go"! It seems like homeopathy-esque nonsense but I'd be glad to be wrong.

I don't mean to be rude but please do some research before posting nonsense.

 

[Jack Straw]

I've recently read about the Neuromod Lenire device and it looks to me like another medical con people will laugh about in years to come. Of course I hope I'm wrong. But I think it's going to join the list of wobble machines and abs electric pulse exercise tools.

But that's what scams rely on. People prepared to pay money to "give it a go"! It seems like homeopathy-esque nonsense but I'd be glad to be wrong.

You obviously haven't been reading enough then.

There are three organization studying this technology and treatment and we have seen it work with forum members. I understand being skeptical, but I can guarantee this is not a scam.

There is actual science backing this and it doesn't have to do with emotional decrease in THI like sound therapies.

 

[GlennS]

it looks to me like another medical con people will laugh about in years to come.

I guess I spoke too soon to think I could retire this GIF.