Lenire — Bimodal Stimulation Treatment by Neuromod

[Paul1980]

It may be off topic but visa restrictions for US citizens in Ireland is 90 days w/out visa, maybe more with. You may have to prove you have the funds to be there the whole time.

I am still waiting for an appointment.

 

[Chinmoku]

No, I have not gotten an answer either.

I emailed them with no answer so far.

 

[Kratos]

for a great part of tinnitus sufferers the tinnitus subsides or goes away after the first few months.

[citation needed]

 

[Alex Matyjasek]

I wonder if one day there will be a clinic in Spain offering this treatment? It's not a big deal considering flying from Barcelona to Dublin is probably 30€ per flight, but it would be convenient having a clinic a little bit closer and at the same time make the trip a little bit cheaper...

(No hotels would be a bonus).

 

[linearb]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

 

[ChrisBoyMonkey]

[citation needed]

No wonder Kratos is always angry. He has tinnitus.

 

[kelpiemsp]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

I'd carry it on as iPod. Seriously. It plays music through headphones from a white rectangle. It's also not for resale. I really think our agents are looking for other things. Alternatively, mail to yourself separately.

 

[Karl28]

What about mailing Lenire back to the United States?

 

[Allan1967]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

Separate the parts and pretend it's an MP3. Walk through customs with the headphones around your neck like a dude. Pretend the tongue device is a tongue scraper.

I'm there next week.

 

[AVIYT]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

Or you just don't declare it and throw away the box? Put the headphones on. Same way you buy laptops or watches and take them through unwrapped. They don't check that much.

 

[El BUZZ]

I wonder if one day there will be a clinic in Spain offering this treatment? It's not a big deal considering flying from Barcelona to Dublin is probably 30€ per flight, but it would be convenient having a clinic a little bit closer and at the same time make the trip a little bit cheaper...

(No hotels would be a bonus).

Hope this doesn't fall in the hands of GAES. That hideous company charges €7000 for its outrageous TRT therapy. How is that going to compete against a way more promising €2500 device, compadre?

 

[Jack Straw]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

I remember reading someone said that you can do installment payments of 400 dollars

 

[JohnAdams]

People travelling from the US, how are you planning on bringing the device back? Since it costs more than $800, you have to declare it just from the point of view of paying duty; since you have to declare it, you either have to be completely up front that it is a medical device that's not approved in the US, or you're playing games with one of the scarier police forces in the country.

I am not a doctor but my take on the FDA page is that bringing an unapproved device into the US is possible, generally requires the cooperation of a doctor here, and some bureaucratic headaches.

If I was going to spend ten thousand dollars to spend three months in Ireland I believe I would take the trouble to do it the hard way. The risks of just bringing it back in a carry-on might be pretty low, but the stakes if you get caught seem unreasonably high to me; confiscation is one obvious scenario, but more dire things are possible depending on what effort is made to deceive or lie to border control.

Well, it looks like an mp3 player, so sneaking it in shouldn't be a problem, right? Just get an Apple logo sticker and slap that bad boy on it.

Pretend the tongue device is a tongue scraper.

Yeah pack it in with your toothbrushes.

 

[Otana]

I don't think customs would notice this device if brought back to the US. But you could always try the FDA expanded access route for non-FDA approved medical devices if you want to play it safe. Just need to get a sponsor physician and hope it gets approved.

https://www.fda.gov/medical-devices...exemption-ide/expanded-access-medical-devices

 

[Alex Matyjasek]

Hope this doesn't fall in the hands of GAES. That hideous company charges €7000 for its outrageous TRT therapy. How is that going to compete against a way more promising €2500 device, compadre?

If this device is the real deal, GAES will have to accept that their days being a bunch of thieves are over. If it does end up in their hands and they charge more, well it's just a case of going somewhere else. I doubt very much though it's going to affect them that much considering they mainly specialize in hearing loss and not tinnitus... Spain is such a corrupt country, full of opportunists, everyone has a price tag... We just have to keep our eyes open.

 

[linearb]

Well, it looks like an mp3 player, so sneaking it in shouldn't be a problem, right? Just get an Apple logo sticker and slap that bad boy on it.

I basically agree and the Apple sticker is a funny idea.

That said, there appears to be a pretty well defined and reasonable process to do this "the right way", so, while I look forward to reading about other people's adventures with customs... I'm not gambling $10,000 to avoid some paperwork, so if I do this before US sale I'm just going to deal with my doctors and the FDA. If it comes to that, I'll let everyone know the process I follow, but, this is relatively low on my list of priorities at least until we have more data including some longitudinal outcomes and a total lack of "this thing is cheaply made and gives tongue burns" comments.

 

[Agrajag364]

this is relatively low on my list of priorities at least until we have more data including some longitudinal outcomes.

 

[Ringeee]

this thing is cheaply made and gives tongue burns" comments.

Have people said this?

 

[Lucifer]

Have people said this?

I would assume it wouldn't cost that much to make. Majority of the cost will be to cover the visits, R&D and clinical trials.

 

[GlennS]

Have people said this?

Not yet. People are making things up to kill time right now.

 

[spedgas]

Have people said this?

No.

 

[ChrisBoyMonkey]

Have people said this?

I remember hearing from someone that the tonguetip is a little flimsy but that's about it.

 

[Ken219]

starting to doubt everything.

It is only natural to have doubts. Look at TRT 26 years later they say it is ineffective! What a shame!

 

[linearb]

Not yet. People are making things up to kill time right now.

If you read my quote in context, I was not making anything up, I was providing a caricature of possible outcomes to explain my hesitancy to commit resources.

I don't tend to gravitate towards syntax which is the most succinct, which can create some confusion, especially on board with large international presences. I do a lot of things pretty well; brevity is not among them.

 

[FGG]

Couldn't you guys from the US just store it in a locker somewhere for the 6 weeks rather than hauling it back and forth or find someone to hold it for you?

 

[GlennS]

This thread used to be full of joking around in order to pass the time but this thing is coming out now. I'm starting to see a lot of new people come into this thread looking for hard information. That's why they're taking what people have been saying about most recently as gospel. It might be best to adopt a more serious tone going forward.

 

[Liz Windsor]

I just want to add my name to the list of people with an appointment at Neuromod. I received an email from them on Wednesday last week (14th day...) offering me a date and time, which I accepted immediately in case they changed their mind! It's on Tuesday 16th July at 3pm - anyone else from Tinnitus Talk around then?? It might be nice to say hello in the waiting room if there is one... By the way, I'm from the UK.

 

[KotaDomowa]

What do you think, will Neuromod have problems if I come in to the appointment with an interpreter?

 

[BigNick]

I have an appointment on the 2nd of July. I'm from the U.K.

 

[EDDTEKK]

It seems patients from the UK and Ireland were preferred getting early appointments.
If so, do you think there is any reason for it?