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Lenire — Bimodal Stimulation Treatment by Neuromod

I just receieved a reply from Neuromod, at least they haven't forgotten about me.
I will see how things go from here:

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Do I understand correctly:

Is your tinnitus quieter than before you started using lenire?
Is it below your baseline (before the spike)?

Sorry to push for the answer but I'm very anxious to see how it goes for you.
I've just gone and sat in a completely quiet room to focus on my tinnitus and get you guys a more definitive answer. In short, yes, the majority of my tinnitus is quieter than it has been. Normally I have multiple tones (rings) at different frequencies and a constant, high pitched, static sounding tone.

Usually the multiple rings are the most prominent and the hardest to ignore. Today, however - the most prominent is the constant, high pitched, static sound. The other tones are sat in the background ever so slightly quieter.

Whether this is due to just having a "better" day with tinnitus or the treatment, I can't say definitively. Although I was in a loud car workshop last night and didn't get to sleep until 1-2am this morning (usually the perfect recipe for a bad day).

As much as I want to sit here and tell everybody the treatment is working, I'm reluctant to make any definitive statements this early on. I did read that on average it supposedly takes around 3 weeks to start seeing positive changes.
 
Yes, it's calmed down much more than it was :rockingbanana:

How are you getting on bud? Have you picked up your device now?
Just driving back from Neuromod now, with Lenire in the boot. I had a good chat with Caroline about the temporary increase in tinnitus or at the least the perception of it and mentioned that a few Tinnitus Talk users reported worsening, that seemed to at least have returned to baseline after a few days. Really interesting conversation, she is very knowledgeable about tinnitus and scientific trials in particular.

One really interesting thing she said regarding the lack of placebo in the trial, was that the follow up out to 12 months was in fact a placebo trial in itself. The fact that people were seeing the benefits out to 12 months (9 months after treatment stopped) showed that they could no longer be experiencing a placebo affect.
 
I've just gone and sat in a completely quiet room to focus on my tinnitus and get you guys a more definitive answer. In short, yes, the majority of my tinnitus is quieter than it has been. Normally I have multiple tones (rings) at different frequencies and a constant, high pitched, static sounding tone.

Usually the multiple rings are the most prominent and the hardest to ignore. Today, however - the most prominent is the constant, high pitched, static sound. The other tones are sat in the background ever so slightly quieter.

Whether this is due to just having a "better" day with tinnitus or the treatment, I can't say definitively. Although I was in a loud car workshop last night and didn't get to sleep until 1-2am this morning (usually the perfect recipe for a bad day).

As much as I want to sit here and tell everybody the treatment is working, I'm reluctant to make any definitive statements this early on. I did read that on average it supposedly takes around 3 weeks to start seeing positive changes.
H O P E.
 
How long ago did you submit your booking assessment? I did mine about 12 days ago and am getting a little antsy waiting for a reply.
On July 21st. They just take a very long time to reply. They do say you may expect to wait for a reply up to 14 days though. I would assume they have a lot of assessments and demands to go through.
 
For those of us in the U.S. I'm pushing as much as I can even if it helps one person---
My email to Neuromod said:
Any chance you're going to send a rep to the East Coast of the U.S., say VA hospital Philadelphia Audiology or New York to train someone to set the device. I assume payment could be worked out to go straight to your company upon pick up. Or even a large contract drawn up for them to hold the devices for issue, which they currently due with hearing aids. I can walk into any VA and within minutes see someone with a hearing aid who has Tinnitus. I can even walk to the next building at UPENN audiology and see the same thing daily. I ran into a Vietnam Vet on base yesterday who is afflicted with it. It is the number 1 disability in the military and the biggest market in the world. Thank you for your time.
Neuromod's response said:
Thank you for your e-mail. At this time, Lenire(R) has not yet been reviewed by the US FDA and so is not cleared for sale in the United States. We are working hard to prepare for US regulatory filing, and the US VA will be an important organisation for us, once the device is cleared for sale.

We recently provided an update on our US regulatory preparations on our website:

www.neuromoddevices.com/newsroom/2019/neuromod-broadens-senior-leadership-team

If you are interested in being kept up to date on news about our company, please sign up to our mailing list:
www.neuromoddevices.com/signup

With best wishes
Neuromod Devices
 
Here's Neuromod's response:

In the online booking assessment, information is provided about the hearing thresholds for which Lenire® can be configured. This information was added to the booking assessment approximately three weeks ago.

For question 9 of the booking assessment, if the answer is yes to: Do you have hearing loss? then the following advice is provided:

Please note that Lenire® can only be recommended for you if you have hearing level (AC pure tone audiometry) thresholds of no more than 40 db HL at 250 Hz, 500 Hz and 1000 Hz, and not more than 80 db HL at 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz and 8000 Hz in either ear at one frequency or more. You may want to consult your audiologist before accepting an appointment if you are unsure of your hearing level thresholds. If you have a copy of your Pure Tone Audiogram, please bring it with you if you accept an appointment with Neuromod Medical.

The following illustration may be informative; if a patient's audiogram dips below the red/blue lines at any point for either ear, then Lenire® cannot be configured for their hearing profile.

View attachment 31262


For question 8 of the online booking assessment, if the answer is yes to "Have you had your hearing tested by a qualified Audiologist?" it is advised "If possible, we advise that you bring a copy of your most recent audiogram to your appointment in Neuromod Medical"

The Neuromod Medical audiologist will review this audiogram, and using his or her expert audiological clinical knowledge will determine whether to conduct a hearing test at Neuromod Medical.

The Neuromod Medical website provides more information about the Tinnitus Assessment visit;

Neuromod Medical offers tinnitus assessments and treatment with the Lenire™ tinnitus treatment system, a breakthrough evidence-based home-use medical device from Neuromod Devices. At Neuromod Medical you will meet a dedicated team of professionals led by an audiologist specialised in tinnitus, who will conduct a thorough diagnostic assessment and provide recommendations on treatment options. For any treatment other than Lenire™, Neuromod Medical will be happy to refer you to an appropriate specialist.

What to expect when you visit Neuromod Medical

Full Diagnostic Assessment

An assessment visit to Neuromod Medical will take approximately 90 minutes and cost €250. Upon arrival, you will be asked to complete a number of medical history forms and tinnitus questionnaires in the waiting room. You will then meet the clinical audiologist, who will review your medical history, discuss your tinnitus and your treatment goals, and conduct a number of standardised clinical assessments. If Lenire™ is an appropriate treatment option for you, you will meet the fitting specialist who will demonstrate the device and thereafter a member of the administrative team will explain the cost of the treatment plan and organise a date for your first treatment visit (approximately 2 weeks later). If Lenire™ is not an option for you, we will be happy to suggest alternative options and refer you to another specialist outside of the Neuromod Medical.
What worries me is that, just like hearing aid companies, they are only occupied with the lower part of our frequency span (.250-8 kHz) and not the upper span (8-20 kHz) where me and many others have their hearing loss and tinnitus.

Is this treatment also limited to those who have tinnitus in the lower range?
It's been said before that pitch doesn't matter, but still I'm curious!
 
Well folks, after considering it from many angles I've decided to move to Dublin in November for a week despite not having an appointment yet.

What do you think of this?

Many of you are considering giving a shot to Lenire, even those living abroad. What about renting a room in a house for the duration of the whole treatment? A house shared only with Lenire users.

Probably many of you can't do this because of your jobs or visa restrictions. But if enough people are willing to discuss this in depth I wouldn't mind to be the one organizing all this.

Renting the house and administrating the rooms in a rotating way for them to be used by anyone needing it.

This is a 100% non-profit idea. To be honest would be nice to not have to pay for my place but let's see. I am willing to do it.

Let me know your thoughts.
 
Well folks, after considering it from many angles I've decided to move to Dublin in November for a week despite not having an appointment yet.

What do you think of this?

Many of you are considering giving a shot to Lenire, even those living abroad. What about renting a room in a house for the duration of the whole treatment? A house shared only with Lenire users.

Probably many of you can't do this because of your jobs or visa restrictions. But if enough people are willing to discuss this in depth I wouldn't mind to be the one organizing all this.

Renting the house and administrating the rooms in a rotating way for them to be used by anyone needing it.

This is a 100% non-profit idea. To be honest would be nice to not have to pay for my place but let's see. I am willing to do it.

Let me know your thoughts.
I'm actually interested. I was thinking of something along these lines myself, maybe even getting a temp job out there while undergoing treatment. I was thinking not even necessarily in Dublin, but somewhere nearby to save costs.
 
I might pop around for a buzz and a smoke!

Not sure about moving there as it's really cheap to fly from Hamburg but I will think about it.
Well I need to wait for the appointment anyway :) They said probably next year.
 
I'm actually interested. I was thinking of something along these lines myself, maybe even getting a temp job out there while undergoing treatment. I was thinking not even necessarily in Dublin, but somewhere nearby to save costs.
I've been thinking about Galway as it's way cheaper than Dublin and not as overgentrified as Cork. It's just a two and a half hours drive from Dublin and it's a well equipped city despite being rather small.
 
I've just gone and sat in a completely quiet room to focus on my tinnitus and get you guys a more definitive answer. In short, yes, the majority of my tinnitus is quieter than it has been. Normally I have multiple tones (rings) at different frequencies and a constant, high pitched, static sounding tone.

Usually the multiple rings are the most prominent and the hardest to ignore. Today, however - the most prominent is the constant, high pitched, static sound. The other tones are sat in the background ever so slightly quieter.

Whether this is due to just having a "better" day with tinnitus or the treatment, I can't say definitively. Although I was in a loud car workshop last night and didn't get to sleep until 1-2am this morning (usually the perfect recipe for a bad day).

As much as I want to sit here and tell everybody the treatment is working, I'm reluctant to make any definitive statements this early on. I did read that on average it supposedly takes around 3 weeks to start seeing positive changes.
Wow sir, thank you for the update. I know you aren't confirming anything at all, but it seems like the light at the end of the tunnel is still shining. I truly wish you the best in your treatment.
 
I've just gone and sat in a completely quiet room to focus on my tinnitus and get you guys a more definitive answer. In short, yes, the majority of my tinnitus is quieter than it has been. Normally I have multiple tones (rings) at different frequencies and a constant, high pitched, static sounding tone.

Usually the multiple rings are the most prominent and the hardest to ignore. Today, however - the most prominent is the constant, high pitched, static sound. The other tones are sat in the background ever so slightly quieter.

Whether this is due to just having a "better" day with tinnitus or the treatment, I can't say definitively. Although I was in a loud car workshop last night and didn't get to sleep until 1-2am this morning (usually the perfect recipe for a bad day).

As much as I want to sit here and tell everybody the treatment is working, I'm reluctant to make any definitive statements this early on. I did read that on average it supposedly takes around 3 weeks to start seeing positive changes.
You mentioned a spike in your visual snow. Has that calmed down, too?
 
Well folks, after considering it from many angles I've decided to move to Dublin in November for a week despite not having an appointment yet.

What do you think of this?

Many of you are considering giving a shot to Lenire, even those living abroad. What about renting a room in a house for the duration of the whole treatment? A house shared only with Lenire users.

Probably many of you can't do this because of your jobs or visa restrictions. But if enough people are willing to discuss this in depth I wouldn't mind to be the one organizing all this.

Renting the house and administrating the rooms in a rotating way for them to be used by anyone needing it.

This is a 100% non-profit idea. To be honest would be nice to not have to pay for my place but let's see. I am willing to do it.

Let me know your thoughts.
That seems like a really interesting proposal for fellow sufferers, but what's the point if you don't have an appointment date yet? They've said they're booked up until next year now, so the only way you'll get a slot is if someone else cancels. They said when I was there that they've had a few no-shows, mainly from people overseas booking appointments and then not turning up.
To my mind, booking a slot without knowing that you can and will attend is just causing problems for Neuromod and making it more difficult for other people who can go but can't get a slot.

Back to your idea, why would you need to be there for a week? The appointments only take 1-2 hours each, but they're spread 6wks apart. So you either need to truck back and forth for each individual appointment or you'd need to stay in Ireland for c.4 months.
 
I did my first proper session this morning.

Initial thoughts;

  • The tongue tip sensation is quite pleasant, not irritating like I expected it to be.
  • The music/noises are a bit eerie, almost sad.
  • There's white noise, electronic chirps, piano and some thunder/rain (I think).
  • The sounds change a bit throughout the treatment, but it's basically the same music for 28 minutes and then wind down for 2 minutes.
  • I felt really spaced out during and after the session, like meditation. That's most likely got more to do with do nothing for 30 minutes than the Lenire.
 
Well... This yank actually is 1/2 Irish, my grandfather was from Galway which I saw someone here was considering staying at while he was doing the treatment. I was planning on visiting there to see the one wall of brick that still stands of my grandfather's homestead. I worked for a major airline carrier here so I have flight benefits that will take me there...

So if the good Lord sees fit I will be accepted and across the puddle I come...
 

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