University of Minnesota Tinnitus Research with Acoustic and Body Stimulation

[GlennS]

My reading of the email is the same, I don't think we will ever see any device coming from the Sonic Lab (UoM). I think Dr. Lim transferred what was left from that research to Neuromod.

Here's the thing. Don't all three devices go through three different body locations to apply the stimulation? That could be a factor for why UoM seemed to work better than Lenire (plus the Bluetooth vs. wired). To assume that all three are interchangeable seems like a mistake.

 

[Bartoli]

Hi All!

I was curious about how the development of the Minnesota device is going, so I decided to drop an email to Dr. Hubert Lim, who is the head of the Sonic Lab at UoM and also works for Neuromod. I got an answer within a day and I decided to share it here to start some discussion about the prospects of the device.

"Hi Daniel,

Thank you for your interest in my lab's research on tinnitus. Based on past animal research from my lab, we discovered that sound combined with electrical stimulation of the ear or of the tongue drives strong plasticity/changes in the auditory brain relevant for tinnitus treatment. As a result, we pursued a human study in my lab with electrical stimulation of the ear combined with sound stimulation. My part-time PhD student who oversaw that study is still analyzing those data and will prepare a manuscript for journal submission. In the meantime. I also began working with Neuromod Devices in Dublin, Ireland to help them develop their approach with electrical stimulation of the tongue combined with sound stimulation, mainly because of the positive results we found in my lab's previous animal research. Although the original intention was to build a multi-modal device through my lab, Neuromod Devices already had made considerable progress towards a medical device ready for human use. So, I felt that the quickest and most effective route to getting a treatment option to the tinnitus community would be to work together with Neuromod Devices rather than build a completely new medical-grade device in my lab, which as you can imagine takes many years to get to clinical use. Therefore, I started to work with them to ensure we can share and combine our ideas towards creating the best treatment option possible between our teams.

Hope that answers your question.

Wishing you continued health during these unique covid times,

Hubert"

Didn't they take Lim on board around the time they were launching? I suppose that means none of Lim's research has found its way into the current version of Lenire?

 

[GlennS]

I suppose that means none of Lim's research has found its way into the current version of Lenire?

From the Vimeo presentation I got the sense that the reprogramming at half-way was Lim's idea. Not having access to it anymore I can't verify but it sure seemed like he was taking credit for that idea--which hasn't fared well in the field.

 

[jmasterj]

Didn't they take Lim on board around the time they were launching? I suppose that means none of Lim's research has found its way into the current version of Lenire?

That is my understanding. They were pretty much ready to release when Neuromod brought on Lim. He mostly did presentations at various hearing/audiology events. I know Neuromod used some of Lim's earlier research to develop their device, but he wasn't involved at all. Maybe in Lenire 2.0. Of course I have 1.0 and it is pretty much a 2500 dollar paper weight.

 

[jmasterj]

Here's the thing. Don't all three devices go through three different body locations to apply the stimulation? That could be a factor for why UoM seemed to work better than Lenire (plus the Bluetooth vs. wired). To assume that all three are interchangeable seems like a mistake.

That is true. Neuromod uses the tongue, Minnesota uses the ear (though Lim in his research mentions the tongue as a good pathway as well), and Michigan uses the jaw and neck based on where you can modulate your tinnitus.

 

[Chinmoku]

From the Vimeo presentation I got the sense that the reprogramming at half-way was Lim's idea. Not having access to it anymore I can't verify but it sure seemed like he was taking credit for that idea--which hasn't fared well in the field.

Yes, at least from a number of anecdotal reports here.

Re-reading this thread I feel sad, I don't think Lenire really incorporated Minnesota. I feel like we all have lost an opportunity despite Dr Lim's statements above.

 

[Bartoli]

From the Vimeo presentation I got the sense that the reprogramming at half-way was Lim's idea. Not having access to it anymore I can't verify but it sure seemed like he was taking credit for that idea--which hasn't fared well in the field.

Is that the infamous presentation that nearly no one has seen and was taken off the internet soon after?

 

[annV]

From the Vimeo presentation I got the sense that the reprogramming at half-way was Lim's idea. Not having access to it anymore I can't verify but it sure seemed like he was taking credit for that idea--which hasn't fared well in the field.

Is that the infamous presentation that nearly no one has seen and was taken off the internet soon after?

The presentation is here.

https://gofile.io/d/xNChhH

Get it now because Neuromod wants all of this deleted, I bet it will take less than 10 hours for this to be gone.

 

[MarkLud]

I try to be positive with all of this stuff and have come a long way as far as getting used to my tinnitus, coping, etc. That said, this sounds pretty terrible on the surface lol. I had extremely high hopes for a Minnesota device based on Kelpie's success.

 

[Mathew Gould]

I try to be positive with all of this stuff and have come a long way as far as getting used to my tinnitus, coping, etc. That said, this sounds pretty terrible on the surface lol. I had extremely high hopes for a Minnesota device based on Kelpie's success.

What happened? The Minnesota device is not that good now?

 

[Croaker]

What happened? The Minnesota device is not that good now?

It was abandoned in favor of Lenire.

 

[Mathew Gould]

It was abandoned in favor of Lenire.

Might be a good thing if it was very similar anyways??

Why? Because of Lim choosing Lenire??

 

[just1morething]

@just1morething if you are in the area...

I wonder if it's too late to look into?

 

[tommyd87]

The presentation is here.

https://gofile.io/d/xNChhH

Get it now because Neuromod wants all of this deleted, I bet it will take less than 10 hours for this to be gone.

No longer exists.

 

[just1morething]

I wonder if @kelpiemsp had to sign a NDA? He doesn't seem around anymore.

 

[Emgee]

It's crazy how bimodal stimulation is missing a huge opportunity right now. While Lenire is available (controversial effectiveness), where is Susan Shore's device? Where is the University of Minnesota device?

In a few years, it appears that we can expect FX-322, OTO-413, the Hough pill, and other regenerative medicines. In my opinion, these medicines offer the highest likelihood of really putting a dent into tinnitus. These medicines are designed to treat the underlying cause (hearing loss/damage), which should produce the most efficacious results. If bimodal stimulation devices come out around the same time as regenerative medicine, what is the point? It's going to be too late when they finally reach the market.

 

[FGG]

It's crazy how bimodal stimulation is missing a huge opportunity right now. While Lenire is available (controversial effectiveness), where is Susan Shore's device? Where is the University of Minnesota device?

In a few years, it appears that we can expect FX-322, OTO-413, the Hough pill, and other regenerative medicines. In my opinion, these medicines offer the highest likelihood of really putting a dent into tinnitus. These medicines are designed to treat the underlying cause (hearing loss/damage), which should produce the most efficacious results. If bimodal stimulation devices come out around the same time as regenerative medicine, what is the point? It's going to be too late when they finally reach the market.

Not every cause of tinnitus is cochlear. You can have conductive problems (middle ear), TMJ, neck injury, etc. While many of these are treatable, they can take a long time (years) and some aren't. Effective bimodal stimulation is definitely still needed.

 

[Emgee]

Not every cause of tinnitus is cochlear. You can have conductive problems (middle ear), TMJ, neck injury, etc. While many of these are treatable, they can take a long time (years) and some aren't. Effective bimodal stimulation is definitely still needed.

They're definitely needed, especially in the case of non-cochlear causes. I'm just upset with the time it has taken to get these devices developed. I understand they want them to be efficacious, but it seems like progress has taken forever.

In the case of direct cochlear damage/causes, bimodal devices will certainly lose out on potential users. While bimodal stimulation will still be successful, the field as a whole is missing out on a massive opportunity right now as they could have bridged the gap until regenerative medicine hits the market.

 

[tommyd87]

They're definitely needed, especially in the case of non-cochlear causes. I'm just upset with the time it has taken to get these devices developed. I understand they want them to be efficacious, but it seems like progress has taken forever.

In the case of direct cochlear damage/causes, bimodal devices will certainly lose out on potential users. While bimodal stimulation will still be successful, the field as a whole is missing out on a massive opportunity right now as they could have bridged the gap until regenerative medicine hits the market.

The system Susan Shore is investigating is interesting. It seems that there is no real progress with it, if anyone asks about it (like people on here have) there seems to be vague information released and that there is no knowledge around whether it will be actually released or whether it will be proven to function effectively.

Essentially I am wondering whether this device or similar either simply do not work at all or there is far too much mucking around to try and get something on the market maybe due to the manufacturer being an absolute perfectionist.

 

[WillBeNimble]

The system Susan Shore is investigating is interesting. It seems that there is no real progress with it, if anyone asks about it (like people on here have) there seems to be vague information released and that there is no knowledge around whether it will be actually released or whether it will be proven to function effectively.

Essentially I am wondering whether this device or similar either simply do not work at all or there is far too much mucking around to try and get something on the market maybe due to the manufacturer being an absolute perfectionist.

So, from what I've gathered, University of Minnesota's device stalled because Lim is working with Lenire.

University of Michigan's (Susan Shore's) device stalled because she needed to run phase 2 tests, but then COVID-19 struck. As such, Shore can't move.

 

[Mathew Gould]

Not every cause of tinnitus is cochlear. You can have conductive problems (middle ear), TMJ, neck injury, etc. While many of these are treatable, they can take a long time (years) and some aren't. Effective bimodal stimulation is definitely still needed.

Which of the NON-bimodal devices will treat tinnitus from neck/TMJ issues??

 

[Emgee]

The system Susan Shore is investigating is interesting. It seems that there is no real progress with it, if anyone asks about it (like people on here have) there seems to be vague information released and that there is no knowledge around whether it will be actually released or whether it will be proven to function effectively.

Essentially I am wondering whether this device or similar either simply do not work at all or there is far too much mucking around to try and get something on the market maybe due to the manufacturer being an absolute perfectionist.

I believe they are currently in their second trial and estimate it to be complete by early fall. It's likely that COVID-19 may impact this plan. There does not appear to be a timeframe for commercialization at this point. Providing it produces some positive effect on tinnitus, it would have been a great device to help us through until regenerative medicine is accessible.

 

[FGG]

Which of the NON-bimodal devices will treat tinnitus from neck/TMJ issues??

Physical therapy and splinting has helped a lot of people with those issues.

 

[UKBloke]

The system Susan Shore is investigating is interesting. It seems that there is no real progress with it, if anyone asks about it (like people on here have) there seems to be vague information released and that there is no knowledge around whether it will be actually released or whether it will be proven to function effectively.

Essentially I am wondering whether this device or similar either simply do not work at all or there is far too much mucking around to try and get something on the market maybe due to the manufacturer being an absolute perfectionist.

Don't forget that Susan Shore set the tinnitus onset criteria in her Phase 2 trial to preferably <1 year. There are huge problems with this.

 

[WillBeNimble]

Don't forget that Susan Shore set the tinnitus onset criteria in her Phase 2 trial to preferably <1 year. There are huge problems with this.

This is a common issue, and while I understand and agree that this doesn't inspire confidence in chronic sufferers, you need to be able to walk before you can crawl. Finding a way to help acute patients is most likely the first step to helping chronic.

 

[UKBloke]

Finding a way to help acute patients is most likely the first step to helping chronic.

I'm not so sure about that. Is the implication that acute and chronic are two separate conditions? Another issue is that even the medical community don't seem able to agree on when acute tinnitus becomes chronic.

 

[tommyd87]

Don't forget that Susan Shore set the tinnitus onset criteria in her Phase 2 trial to preferably <1 year. There are huge problems with this.

This is a common issue, and while I understand and agree that this doesn't inspire confidence in chronic sufferers, you need to be able to walk before you can crawl. Finding a way to help acute patients is most likely the first step to helping chronic.

Yeah @WillBeNimble is correct with his point, although I am again thinking that there is absolutely minimal confidence with this device.

 

[UKBloke]

Yeah @WillBeNimble is correct with his point

I'm not sure what the point is though. Is it that we have to learn to crawl before we can walk, or is the "common issue" something to do with how Phase 2 trials are conducted?

7 years ago when Susan Shore went on the record to declare that her team were developing a device to stop tinnitus she didn't make any inference to acute or chronic or distinguish between the two. She just spoke about tinnitus. And yet here we are in 2020 with a Phase 2 trial in motion where the participant criteria specifically calls for time since tinnitus onset of preferably <1 year, which in my view, is still the acute phase.

If we compare this with Neuromod; despite all their failings re lack of peer review they did at least open their Phase 2 trial to patients with time since tinnitus onset of <5 years meaning the chance of any improvement being attributable to natural remission is greatly reduced. This is a big difference I think that people need to be aware of.

 

[Mathew Gould]

I'm not sure what the point is though. Is it that we have to learn to crawl before we can walk, or is the "common issue" something to do with how Phase 2 trials are conducted?

7 years ago when Susan Shore went on the record to declare that her team were developing a device to stop tinnitus she didn't make any inference to acute or chronic or distinguish between the two. She just spoke about tinnitus. And yet here we are in 2020 with a Phase 2 trial in motion where the participant criteria specifically calls for time since tinnitus onset of preferably <1 year, which in my view, is still the acute phase.

If we compare this with Neuromod; despite all their failings re lack of peer review they did at least open their Phase 2 trial to patients with time since tinnitus onset of <5 years meaning the chance of any improvement being attributable to natural remission is greatly reduced. This is a big difference I think that people need to be aware of.

So Susan Shore's device isn't going to work for anybody who has had tinnitus for over 1 year!?!?!

 

[UKBloke]

So Susan Shore's device isn't going to work for anybody who has had tinnitus for over 1 year!?!?!

Who knows?

One thing I can share; I had an email chat with Thanos Tzounopoulos about this problematic acute/chronic scenario with respect to how his research might apply specifically to someone in the chronic phase. He just stated that the specifics of the trial haven't yet been set. At first I felt this answer might be a bit vague but reading between the lines, I think he's actually spot on by saying that essentially the profile criteria of the trial participants reflects the profile criteria of the end patient the regimen aims to treat. So for us, I suppose we need to be looking at trials that are a bit less strict with time since tinnitus onset.