Q&A: Tinnitus Hub Meets Neuromod (Lenire)

[EDDTEKK]

Neuromod put testimonials on the page but don't inform about any release date. This is a really bad way of promoting it.

We are seeking for any help and if we see such videos, of course we want this device now. Now it feels like a torture not to have access to it.

First show the success you had, and then don't provide the product. Is this fair??

 

[RaZaH]

Patience

 

[Jack Straw]

I think they could at least give an update as to the timeline or the reasons it is being held up. It's not like we haven't been waiting years for something like this... lol.

In all seriousness I hope they release at least a statement soon so we are not in the dark.

 

[GlennS]

https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

Good paper. It goes a long way to providing more detail behind the Q&A video.

• At the time of the study they didn't really have a firm handle on what kind of treatment might yield a particular result.
• They conducted this study by trying out three different treatment variations (the term they use for these is an arm).
• They are deliberately experimenting with sending frequencies not directly related to T. They say they have reason to believe this would work, but don't go into detail for why they feel that way.

In the Q&A video, they explain (I'm going based on memory) that synchronous stimulation worked better than delaying the electrical pulses behind the audio beeps.

My opinion is that based on the small sample size of the trial and tentative trial-and-error nature of the treatment that it would be unrealistic to expect this device to be rolled out in massive numbers as if it's proven technology. At the same time there's no way to keep gathering data and refining it if nobody's using it. It's a chicken and the egg thing as far as deciding who foots the bill. The more this gets positioned as a finished product the higher people's expectations. The more patients feel they're merely test-subjects the less likely they're going to want to pay thousands of dollars in which case this really should be leaning on research grants.

Neuromod put testimonials on the page but don't inform about any release date. This is a really bad way of promoting it.

It's a perfectly good way to promote it... If you're seeking investors. I just don't think they have a ton of money.

 

[Helheim]

Yeah seriously. A statement would do wonders for this company right now.

 

[AliceW]

Dr. Ross O'Neill - Neuromod's Founder and Director has a LinkedIn profile:

https://linkedin.com/in/rossoneill

If someone who is on LinkedIn can contact him directly and ask him for a release date?

(I'm not registered on this website...)

 

[Clare B]

@Clare B,

First: A huge thank you for being so patient and responsive on this forum. I guess you could just as easily walk away and leave this whole tinnitus thing in the past. Your commitment to answering questions from us who are still in this is much appreciated.

From the Q&A I gather there were three conditions in the trial. One condition was receiving the standard treatment, and two were receiving a treatment that was not expected to help.

Could you tell me, how confident you were in the standard condition? Do you know what condition you were in?

I don't mind answering questions but there's a limit to what I know. I know there were different groups where the device was set up differently but I don't know what group I was in. I do know there was no placebo. We were not supposed to know what group we were in.

I think someone posted a link to this document earlier, it gives more technical information.

 

[Clare B]

Thank you Clare B, you're a great human being. I am happy your tinnitus went away and really grateful that you have taken your time to speak to the community. Bless you, you're an angel.

Thank you. I'm glad my tinnitus went away too! It's the least I can do, to give back in some way.

 

[K89]

Thanks @Clare B for sharing your story.

I read a summary of an article produced by Sven Vanneste, part of Neuromod's Science Advisory Board, highlighting the difference in brain activity for tinnitus patience's with hearing loss below and above 20db via EEG:

https://www.ata.org/news/news/two-types-tinnitus-brain

I wonder if this study helps identify which groups saw stronger improvements in the study, i.e. groups showing just auditory hyperactivity or both auditory and parahippocampal hyperactivity. The tongue stimulator is aimed at the auditory system specifically, according to Neuromod, but no mention of the parahippocampal area. Perhaps the effectiveness of the device is linked to which side of the fence you're on.

I also wonder how different the power of Neuromod's device is from the PoNS device (also a tongue ticker) by Helius Medical:

https://heliusmedical.com/index.php/divisions/neurohabilitation/the-pons-device

I can't confirm, but wonder if the Neuromod device is less powerful, given the PoNS is helping other patients regain lost functions like their balance, mobility, sleep, concentration, etc. relatively quickly after an acquired brain injury such as concussions, strokes and brain surgeries. It's also been studied for MS and Cerebral Palsy, and there was one case study posted showing its use in tinnitus suppression for a girl who suffered from a motor vehicle accident:

https://www.academia.edu/35013971/T...translingual_neurostimulation_TLNS_case_study

Mention of 30-35 dB reduction... of course it's only one case study and we don't know all the details. Doesn't seem like it was a severe case. Sounds promising nonetheless, especially to someone like me who had tinnitus after a brain hemorrhage.

Not many tinnitus studies (from what I've read) like to include acquired brain injury folks like myself — Neuromod included.

 

[Agrajag364]

I don't mind answering questions but there's a limit to what I know. I know there were different groups where the device was set up differently but I don't know what group I was in. I do know there was no placebo. We were not supposed to know what group we were in.

I think someone posted a link to this document earlier, it gives more technical information.

Oh that's interesting... No placebo but you were in the second larger twelve-month follow-up trial group. I saw that the first pilot study had a review remark on it saying hopefully the second one would have a placebo. Unfortunate.

Perhaps they thought it would be impractical or there was some ethical objection but generally studies of this nature do have a placebo.

 

[K89]

@Agrajag364

If the tongue piece emits an electrical pulse, In this case I'm guessing participants would know if they were part of the placebo. Perhaps they could have created a less stimulating version as the placebo, but if participants didn't feel the "pop rocks"/champagne bubbles feeling on their tongues at all, the jig would be up.

Similar issue with the PoNS clinical trial for balance and gait. Their placebo group had a lower charged device intended not to work, but people still showed clinically significant improvement, and it actually cause them a bit of a hassle when they reported the results!

https://heliusmedical.com/index.php...-support-application-for-clearance-by-the-fda

 

[spedgas]

I've been on this thread posting understanding words about the yet unannounced release date of this product. I still feel that way. This initial release is in just their home market. This is probably the easiest launch they will have.

I can't imagine the delays involved with releases in markets like Europe and the US.

 

[Agrajag364]

@Agrajag364

If the tongue piece emits an electrical pulse, In this case I'm guessing participants would know if they were part of the placebo. Perhaps they could have created a less stimulating version as the placebo, but if participants didn't feel the "pop rocks"/champagne bubbles feeling on their tongues at all, the jig would be up.

Similar issue with the PoNS clinical trial for balance and gait. Their placebo group had a lower charged device intended not to work, but people still showed clinically significant improvement, and it actually cause them a bit of a hassle when they reported the results!

https://heliusmedical.com/index.php...-support-application-for-clearance-by-the-fda

Thanks... they could still have had a tongue pulse that wasn't properly wired up or something?

 

[JavierGV]

There's one thing in the Neuromod's device I just can't see the point of: the use of expensive Bluetooth earphones. Why such a spending? Wouldn't it be smarter just to provide a 3.5mm mini jack audio output so everyone could use their own earphones? Not to talk about sync delays between Bluetooth audio signal and electrical tongue pulses (I guess they will have sorted this out somehow). I already have 3 wired earphones, a wireless Sennheiser kit and a pair of Bluetooth earbuds, I don't need more.

 

[PDodge]

Release this shite so you can take my monopoly money.

 

[GamesB2]

There's one thing in the Neuromod's device I just can't see the point of: the use of expensive Bluetooth earphones. Why such a spending? Wouldn't it be smarter just to provide a 3.5mm mini jack audio output so everyone could use their own earphones? Not to talk about sync delays between Bluetooth audio signal and electrical tongue pulses (I guess they will have sorted this out somehow). I already have 3 wired earphones, a wireless Sennheiser kit and a pair of Bluetooth earbuds, I don't need more.

While I don't disagree as I've got a nice pair of Sennheiser's myself I'd like to get more use out of, I'm going to assume it's for quality control.

They mentioned in the Q&A that the device and headphones cannot exceed safe dB levels according to EU standards, some headphones would allow you to go louder.

Also, not all headphones are born equal and if they need a specific range of frequency people may not understand that their knock off Beats probably won't be able to deliver what's required, in that case you'd potentially have people not benefiting/claiming it didn't work because of something that Neuromod could, and are, providing.

 

[GregCA]

There's one thing in the Neuromod's device I just can't see the point of: the use of expensive Bluetooth earphones. Why such a spending? Wouldn't it be smarter just to provide a 3.5mm mini jack audio output so everyone could use their own earphones? Not to talk about sync delays between Bluetooth audio signal and electrical tongue pulses (I guess they will have sorted this out somehow). I already have 3 wired earphones, a wireless Sennheiser kit and a pair of Bluetooth earbuds, I don't need more.

The use of Bluetooth headphones tells me the timing is perhaps not that important, but the value of the output volume may be, since the configuration is based on the user's thresholds. They probably didn't want to have to deal with variability around everyone's hardware and dB response across the frequency bands, so they ship with a set of headphones that they've calibrated against.

 

[Jack Straw]

The use of Bluetooth headphones tells me the timing is perhaps not that important, but the value of the output volume may be, since the configuration is based on the user's thresholds. They probably didn't want to have to deal with variability around everyone's hardware and dB response across the frequency bands, so they ship with a set of headphones that they've calibrated against.

This makes me nervous that we will all have to get our sound tolerance levels tested at an audiologist. Seems like a disaster waiting to happen seeing that audiologists have been known to not take caution with tinnitus patients.

 

[GregCA]

This makes me nervous that we will all have to get our sound tolerance levels tested at an audiologist. Seems like a disaster waiting to happen seeing that audiologists have been known to not take caution with tinnitus patients.

They need your hearing thresholds to configure the device, not your sound tolerance levels.

 

[Jack Straw]

They need your hearing thresholds to configure the device, not your sound tolerance levels.

Ah okay, misunderstood you.

 

[Bndsmheowqhe]

This makes me nervous that we will all have to get our sound tolerance levels tested at an audiologist. Seems like a disaster waiting to happen seeing that audiologists have been known to not take caution with tinnitus patients.

I thought I was the only one. When I got tested the audiologist kept banging her hand into the microphone which was extremely loud with my headphones.

Is a little professionalism too much to ask?

 

[Allan1967]

Anyone with any inside info as to when this is coming out?

Email from Neuromod today just saying they are in phase 2 (?) 12 month follow up (didn't say how far into the 12 months they are) and they are working hard.

 

[Jack Straw]

@kelpiemsp just posted this on his profile.

"I am currently experiencing silence for the 1st time in 31 years. No wonder people are so upset. What a strange and nice feeling."​

He has had loud tinnitus his whole life and is currently taking part in trials for a device that is very similar to Neuromod.

If this doesn't convince anyone that this type technology is a step in the right direction, then I don't know what to tell you.

 

[Bart]

@kelpiemsp just posted this on his profile.

"I am currently experiencing silence for the 1st time in 31 years. No wonder people are so upset. What a strange and nice feeling."​

He has had loud tinnitus his whole life and is currently taking part in trials for a device that is very similar to Neuromod.

If this doesn't convince anyone that this type technology is a step in the right direction, then I don't know what to tell you.

What kind of device is this?

 

[Jack Straw]

What kind of device is this?

https://www.tinnitustalk.com/thread...rch-with-acoustic-and-body-stimulation.28022/

Very similar to Neuromod.

 

[Stakovic]

Anyone with any inside info as to when this is coming out?

Email from Neuromod today just saying they are in phase 2 (?) 12 month follow up (didn't say how far into the 12 months they are) and they are working hard.

The price of the device will be very expensive if you continue sending them messages.

 

[pochito]

@kelpiemsp just posted this on his profile.

"I am currently experiencing silence for the 1st time in 31 years. No wonder people are so upset. What a strange and nice feeling."​

He has had loud tinnitus his whole life and is currently taking part in trials for a device that is very similar to Neuromod.

If this doesn't convince anyone that this type technology is a step in the right direction, then I don't know what to tell you.

@kelpiemsp please can you tell us more?

 

[Don Tinny]

@kelpiemsp just posted this on his profile.

"I am currently experiencing silence for the 1st time in 31 years. No wonder people are so upset. What a strange and nice feeling."​

He has had loud tinnitus his whole life and is currently taking part in trials for a device that is very similar to Neuromod.

If this doesn't convince anyone that this type technology is a step in the right direction, then I don't know what to tell you.

Nice!

What are the differences between Neuromod and Minnesota's device? What type of stimulation do they use?

 

[RCP1]

@Steve any chance of getting in touch with Ross O'Neill as regards to release date?

 

[Jack Straw]

Nice!

What are the differences between Neuromod and Minnesota's device? What type of stimulation do they use?

From my understand Neuromod uses the tongue to send electrical impulse and the other device sets up electrodes on your neck. Then the device sends a timing between sound and electrical pulses into the brain/auditory system.