New University of Michigan Tinnitus Discovery — Signal Timing

[Chaz]

So I emailed Dr. Shore asking to participate in the clinical.... I didn't realize I would have to travel to Michigan once a week for 4 months, that would be pretty rough as I live in Houston Tx. If she would have said once a month I would definitely do it, but once a week will cost a fortune in plane tickets and having to take time off work would be hard.

It sounds like with her response to me they are going to start next year 2018.

 

[linearb]

So I emailed Dr. Shore asking to participate in the clinical.... I didn't realize I would have to travel to Michigan once a week for 4 months, that would be pretty rough as I live in Houston Tx.

That's what I did, though I was coming from DC so direct flights DCA -> DTW were easy. I reduced the amount of flights required by usually flying in on Thursday, seeing the lab, then sticking around through the weekend and going to the lab again on Mon or Tues, then back to DC for a week and a half, repeat. There was also a 6 week washout in the first study, so I only had to go once during that. I think I probably did something like 8 round trips total?

It was a bit extreme, but Ann Arbor was cool, and after cycling through a few AirBnBs I found a couple my age with a room for rent that only cost me ~$35/night or so; they were cool, we got along and they had cool pets. I did have one shitty trip that I had to cut short because I'd taken an AirBnB with a bunch of college students, and I am about 10 years past thinking that's a cool environment to be in.

My ability to work from anywhere that has internet access was the only reason this worked out, though.

 

[SCORPION]

Hello all I would like the Doctor's email if that's possible! I have been dealing with this for 23 yrs now and I'm only 25 miles from U of M. I would be willing to get involved for sure...

 

[Samir]

@SCORPION the email address is sushore@umich.edu

You will find her faculty page here:
https://medicine.umich.edu/dept/khri/susan-e-shore-phd

 

[Chaz]

That's what I did, though I was coming from DC so direct flights DCA -> DTW were easy. I reduced the amount of flights required by usually flying in on Thursday, seeing the lab, then sticking around through the weekend and going to the lab again on Mon or Tues, then back to DC for a week and a half, repeat. There was also a 6 week washout in the first study, so I only had to go once during that. I think I probably did something like 8 round trips total?

It was a bit extreme, but Ann Arbor was cool, and after cycling through a few AirBnBs I found a couple my age with a room for rent that only cost me ~$35/night or so; they were cool, we got along and they had cool pets. I did have one shitty trip that I had to cut short because I'd taken an AirBnB with a bunch of college students, and I am about 10 years past thinking that's a cool environment to be in.

My ability to work from anywhere that has internet access was the only reason this worked out, though.

Did it help you at all? I'm still debating on doing it or not. Work would be the biggest hurdle for me.

 

[SCORPION]

Right on Samir thank you I'll check that out asap. CURLY

 

[Markku]

Right on Samir thank you I'll check that out asap. CURLY

Keep us posted - hopefully you are accepted into the trial, best of luck!

 

[SCORPION]

Will do Markku just sent Susan an email fingers crossed.. CURLY

 

[linearb]

Did it help you at all? I'm still debating on doing it or not. Work would be the biggest hurdle for me.

There was a short term benefit and I was amused by contributing to science, but if you're looking for a long term solution then you should wait for them to productize this. You will not be allowed to keep the experimental device after the study, and the effect is expected to be short-lived, wearing off days to weeks after the end of the experimental phase.

I was in a situation where I had the time and money to do this without sacrificing much besides cash that I would otherwise have spent on frivolous things, and it interested me to do so. I was also in the process of figuring out where I wanted to live next, and Ann Arbor seemed possible, so I was killing two birds with one stone. If you're looking at taking time off from work or putting stuff on credit cards to make this happen, I cannot recommend it.

I do not expect to participate in the second study myself, because my life circumstances have changed; I figured out where I wanted to live (not Ann Arbor) and have a family now, so throwing another ~$10K at this to say "yep, that still works, and I'm still pissed off that I have to wait another 2-4 years for them to maybe go to market" seems dubious because that's money I'd really rather spend on having my house repainted or buying an electric motorcycle or paying for a year of community college for kiddo :-P

 

[SCORPION]

I would definitely not be paying anything for this if it's free it's me but if not I've been dealing with this for 23 years I'll just keep pushing on the same way as usual but thanks for the advice.

But I did get ahold of Susan and she did put me down on a list so I'm just weighing out my options to check out what they have to say like I said I'm only 25 miles from the University and a bonus is I do have great insurance so maybe something can be worked out you never know. Curly

 

[Jab4]

They just put my name on the list. Seems like a long wait. Trail won't start until
August 2018

 

[threefirefour]

They just put my name on the list. Seems like a long wait. Trail won't start until
August 2018

It was supposed to be this year. Not a good sign they keep pushing the date back.

 

[Jab4]

They just put my name on the list. Seems like a long wait. Trail won't start until
August 2018

 

[linearb]

It was supposed to be this year. Not a good sign they keep pushing the date back.

Nah; this is just a reflection of the general difficulties involved in running clinical trials at scale. It was never "supposed" to be anything; after they got the phase-I results they started trying to line money up. They would have jumped into a phase-II this year if the cash and FDA angles had worked out faster, but here we are. This is still moving much faster than most drug trials do.

Note that the first year of the next trial is animal work only, so stuff with humans won't start again until 2019ish.

 

[BuzzyBee]

Nah; this is just a reflection of the general difficulties involved in running clinical trials at scale. It was never "supposed" to be anything; after they got the phase-I results they started trying to line money up. They would have jumped into a phase-II this year if the cash and FDA angles had worked out faster, but here we are. This is still moving much faster than most drug trials do.

Note that the first year of the next trial is animal work only, so stuff with humans won't start again until 2019ish.

Wow, it's taking forever. I'll bet by then there will be other devices or possibly pills or even medications that can at least alleviate it for people with very severe, intrusive tinnitus.

 

[threefirefour]

Nah; this is just a reflection of the general difficulties involved in running clinical trials at scale. It was never "supposed" to be anything; after they got the phase-I results they started trying to line money up. They would have jumped into a phase-II this year if the cash and FDA angles had worked out faster, but here we are. This is still moving much faster than most drug trials do.

Note that the first year of the next trial is animal work only, so stuff with humans won't start again until 2019ish.

What do you mean this isn't supposed to be anything? Does that mean no reduction or treating tinnitus? Then what's the point?

 

[linearb]

What do you mean this isn't supposed to be anything? Does that mean no reduction or treating tinnitus? Then what's the point?

No, sorry, lack of clarity: you said the trial was "supposed" to start in 2018. That's not true, they haven't missed any milestones. The signaling all along has been "we think we're on to something and we're trying line up funding to prove it", and that remains the case.

The goal of the tech is to reduce the subjective experience of tinnitus on a temporary basis. They believe they have demonstrated an effect in animals and a small number of humans which represent some significant minority of the tinnitus population. What the long term effects of continued treatment over months or years is, is not something which has even been speculated about, as far as I know (nor will the Phase-II attempt to solve that). The range of possibilities, then, is probably (from most pessimistic to most optimistic): "this doesn't actually work the way we thought it did, it does nothing"; "this works for some people for a short period of time and then the effect wears off"; "this works for some people over an extended period of time as long as the treatment is continued"; "some people achieve a reduction of tinnitus with long-term therapy which is sustained after cessation of device use".

They're definitely tinkering with some interesting and novel neurological mechanisms, and I think it's pretty reasonable to expect that whatever happens, some useful things about tinnitus will be learned. My own subjective experience was that there did seem to be an effect which was achieved after ~14 days of use, and sustained for 14 days of use and then tapered off within a day or two following discontinuation. However, if this actually turned into a product right off the bat in 2020-2024 which dramatically reduced tinnitus in the long-term in a majority of patients, I'd be somewhat surprised.

 

[BuzzyBee]

My own subjective experience was that there did seem to be an effect which was achieved after ~14 days of use, and sustained for 14 days of use and then tapered off within a day or two following discontinuation. However, if this actually turned into a product right off the bat in 2020-2024 which dramatically reduced tinnitus in the long-term in a majority of patients, I'd be somewhat surprised.

It must have been nice to have those 14 days! Too bad you had to discontinue use and then go back to your normal level, but if the device really gave you 14 good days, that's terrific.

 

[threefirefour]

No, sorry, lack of clarity: you said the trial was "supposed" to start in 2018. That's not true, they haven't missed any milestones. The signaling all along has been "we think we're on to something and we're trying line up funding to prove it", and that remains the case.

The goal of the tech is to reduce the subjective experience of tinnitus on a temporary basis. They believe they have demonstrated an effect in animals and a small number of humans which represent some significant minority of the tinnitus population. What the long term effects of continued treatment over months or years is, is not something which has even been speculated about, as far as I know (nor will the Phase-II attempt to solve that). The range of possibilities, then, is probably (from most pessimistic to most optimistic): "this doesn't actually work the way we thought it did, it does nothing"; "this works for some people for a short period of time and then the effect wears off"; "this works for some people over an extended period of time as long as the treatment is continued"; "some people achieve a reduction of tinnitus with long-term therapy which is sustained after cessation of device use".

They're definitely tinkering with some interesting and novel neurological mechanisms, and I think it's pretty reasonable to expect that whatever happens, some useful things about tinnitus will be learned. My own subjective experience was that there did seem to be an effect which was achieved after ~14 days of use, and sustained for 14 days of use and then tapered off within a day or two following discontinuation. However, if this actually turned into a product right off the bat in 2020-2024 which dramatically reduced tinnitus in the long-term in a majority of patients, I'd be somewhat surprised.

This product seems to get worse and worse with every revelation...

 

[Jab4]

No, sorry, lack of clarity: you said the trial was "supposed" to start in 2018. That's not true, they haven't missed any milestones. The signaling all along has been "we think we're on to something and we're trying line up funding to prove it", and that remains the case.

The goal of the tech is to reduce the subjective experience of tinnitus on a temporary basis. They believe they have demonstrated an effect in animals and a small number of humans which represent some significant minority of the tinnitus population. What the long term effects of continued treatment over months or years is, is not something which has even been speculated about, as far as I know (nor will the Phase-II attempt to solve that). The range of possibilities, then, is probably (from most pessimistic to most optimistic): "this doesn't actually work the way we thought it did, it does nothing"; "this works for some people for a short period of time and then the effect wears off"; "this works for some people over an extended period of time as long as the treatment is continued"; "some people achieve a reduction of tinnitus with long-term therapy which is sustained after cessation of device use".

They're definitely tinkering with some interesting and novel neurological mechanisms, and I think it's pretty reasonable to expect that whatever happens, some useful things about tinnitus will be learned. My own subjective experience was that there did seem to be an effect which was achieved after ~14 days of use, and sustained for 14 days of use and then tapered off within a day or two following discontinuation. However, if this actually turned into a product right off the bat in 2020-2024 which dramatically reduced tinnitus in the long-term in a majority of patients, I'd be somewhat surprised.

There seemed to be an effect? Can you please elaborate more on this? More details on the effects you had.

 

[linearb]

This product seems to get worse and worse with every revelation...

I remain bullish on this one, but I don't want anyone to come to unrealistic conclusions based on bad data from me. I think it's better than anything else on the market; how much that means depends on one's perspective.

There seemed to be an effect? Can you please elaborate more on this? More details on the effects you had.

I documented this elsewhere but I can't find it and I post too much. In general, the trial required keeping twice-daily subjective self-ratings of tinnitus volume and distress on a 10-point scale. My usual rating for volume flutters between 4 and 8, and distress between maybe 3 and 7. There's a lot of variation there, I get 2 days once in a while, but during the second 2 weeks of the experimental period I flatlined, never noting anything higher than 4 for volume or 5 for distress. That was significant enough that by the end I was (very cautiously, at a low volume) using earbuds again without any distress, which is basically unprecedented over the last ~10 years.

They also attempted to do objective volume matching in the lab, using sound generators in a sound-proof booth, but I have no idea how my scores on that changed (or not) because I was not given access to my full data.

Because of how the tech is supposed to work (details further back in this thread, search for my username), it's critical that patients are able to modulate their tinnitus with muscle movements of a muscle which is innervated by nerves that pass through the temporomandibular junction. This means that if you cannot change the sound or volume of your tinnitus by moving your jaw or neck, it is not likely that this tech will help you. I believe that ~80% of tinnitus patients are able to do this; this tech is likely to help some subset of those people, if it works as the developers believe.

 

[Jab4]

I remain bullish on this one, but I don't want anyone to come to unrealistic conclusions based on bad data from me. I think it's better than anything else on the market; how much that means depends on one's perspective.


I documented this elsewhere but I can't find it and I post too much. In general, the trial required keeping twice-daily subjective self-ratings of tinnitus volume and distress on a 10-point scale. My usual rating for volume flutters between 4 and 8, and distress between maybe 3 and 7. There's a lot of variation there, I get 2 days once in a while, but during the second 2 weeks of the experimental period I flatlined, never noting anything higher than 4 for volume or 5 for distress. That was significant enough that by the end I was (very cautiously, at a low volume) using earbuds again without any distress, which is basically unprecedented over the last ~10 years.

They also attempted to do objective volume matching in the lab, using sound generators in a sound-proof booth, but I have no idea how my scores on that changed (or not) because I was not given access to my full data.

Because of how the tech is supposed to work (details further back in this thread, search for my username), it's critical that patients are able to modulate their tinnitus with muscle movements of a muscle which is innervated by nerves that pass through the temporomandibular junction. This means that if you cannot change the sound or volume of your tinnitus by moving your jaw or neck, it is not likely that this tech will help you. I believe that ~80% of tinnitus patients are able to do this; this tech is likely to help some subset of those people, if it works as the developers believe.

Thanks linearb.

Thanks for your detailed reply.
Sounds more like tinnitus relief than a cure but that's better than nothing.

 

[Markku]

Sounds more like tinnitus relief than a cure but that's better than nothing.

Absolutely agree, being able to reduce tinnitus distress/loudness by a few points on a scale of 1 to 10 without major side effects is nothing to sneeze at. That could sometimes be the difference of a severely debilitating tinnitus and one that can be at least a little bit better coped with.

This means that if you cannot change the sound or volume of your tinnitus by moving your jaw or neck, it is not likely that this tech will help you. I believe that ~80% of tinnitus patients are able to do this; this tech is likely to help some subset of those people, if it works as the developers believe.

This is actually interesting, in our recent, now closed survey (the physical links one), which we got approx 6,100 completed responses for, I believe "only" 46% reported being able to modulate their tinnitus by these movements.

I would have thought it would have been more than that. We'll post the full results once our research contact has started the analysis work - this could take a while still...

But either way, I thank you for sharing your experiences of the trial here, it's been an interesting read.

 

[Greg Sacramento]

Absolutely agree, being able to reduce tinnitus distress/loudness by a few points on a scale of 1 to 10 without major side effects is nothing to sneeze at. That could sometimes be the difference of a severely debilitating tinnitus and one that can be at least a little bit better coped with.

From me: If I was able to have my tinnitus reduced from being severely debilitating by a few points, I'd be very grateful.

 

[BuzzyBee]

Absolutely agree, being able to reduce tinnitus distress/loudness by a few points on a scale of 1 to 10 without major side effects is nothing to sneeze at. That could sometimes be the difference of a severely debilitating tinnitus and one that can be at least a little bit better coped with.


This is actually interesting, in our recent, now closed survey (the physical links one), which we got approx 6,100 completed responses for, I believe "only" 46% reported being able to modulate their tinnitus by these movements.

I wonder if people who reported that they weren't able to modulate their tinnitus just didn't know quite how to modulate it. I cannot modulate mine by clenching, but I've noticed big upswings in tinnitus on occasions when I've moved my neck a certain way or changed posture. It also changes tones when I yawn -- but not always. So maybe people who say they can't modulate their tinnitus may not have pinpointed exactly what muscle or joint movement it is that sets it off.

As far as the device goes, it may not help people who obsess constantly over very low and steady tinnitus (hearing aids should theoretically help with that), but it sounds perfect for people with unmaskable tinnitus that fluctuates wildly or stays between a 7 and a 10 most days. It may also help with feelings of ear fullness relating to muscles spasms.

 

[threefirefour]

Absolutely agree, being able to reduce tinnitus distress/loudness by a few points on a scale of 1 to 10 without major side effects is nothing to sneeze at. That could sometimes be the difference of a severely debilitating tinnitus and one that can be at least a little bit better coped with.

If it can reduce tinnitus on this scale, then by every definition it should be a successful product.

 

[GamingT]

Just got email back from Susan saying she has put me on list to be contacted early next year for trial. I am only 1 hour south of University of Michigan so travel not a problem. Even if it just reduces my tinnitus I will be so happy.

 

[threefirefour]

Just got email back from Susan saying she has put me on list to be contacted early next year for trial. I am only 1 hour south of University of Michigan so travel not a problem. Even if it just reduces my tinnitus I will be so happy.

Awesome. Good for you. Hope you have great success. I wish I could join the trial.

 

[BuzzyBee]

Just got email back from Susan saying she has put me on list to be contacted early next year for trial. I am only 1 hour south of University of Michigan so travel not a problem. Even if it just reduces my tinnitus I will be so happy.

Would you post and keep us updated? I am sure there's a degree of confidentiality to be considered, but whatever info you could share would be appreciated.

 

[GamingT]

Would you post and keep us updated? I am sure there's a degree of confidentiality to be considered, but whatever info you could share would be appreciated.

Sure thing. Assuming that they accept me I will definitely make update to date posts about how effective it is for me.