New University of Michigan Tinnitus Discovery — Signal Timing

[awake 44]

I'm not that scared of TFI not being reduced significantly. If the study objects were new sufferers (<6 months), their feelings were totally distorted by panic/lack of understanding/hate towards doctors. Even when they felt better, they might have been frustrated that they do not have 100% silence.

 

[UKBloke]

Maybe the TFI scores reflect the fact that the participants' tinnitus was of fairly recent onset <one year, so habituation yet has to do its part of reducing the distress in general, so even with a good reduction in intensity, the TFI scores would still be significant because participants will only be happy with total silence. Just a theory.

I think that sounds like a very good theory.

 

[Nick47]

I saw a mention recently (I think somewhere on this forum) of data showing that a cochlear implant in one ear reduced tinnitus in both ears for a significant number of people.

@ploughna, yes that was me I'm just trying to look at options here as I'm incapacitated at times with this. Not deep enough hearing loss for a cochlear implant but too deep for hearing aids to benefit. I feel fcuked! Basically severe to profound deafness from 4000 Hz - 8000 Hz in one ear and that's driving the bilateral tinnitus. @dj_newark did ask Dr. Shore about wearing the ear piece in one ear, with her replying it usually reduces perception of tinnitus in both ears BUT well, there are questions that can't be answered yet due to the parameters set on the study.

 

[Aussie Lea]

I don't mean to derail from this amazing news, but as someone who now has more than tinnitus to worry about, do you guys think this device getting FDA approval and becoming available to the public will affect hearing loss research in anyway?

Not even conspiracy theorists could come up with that line of thinking. This device does not touch hearing loss and hearing loss remains an issue that is very lucrative for anyone who comes up with solutions. The work there continues for sure.

 

[Sironketchup]

Considering Dr. Shore has tinnitus herself, it makes me even more excited about this.

A doctor having tinnitus and coming up with positive results after 10 years sounds just too big for just another scam.

But well, you never know.

 

[Fightthearmy]

Considering Dr. Shore has tinnitus herself, it makes me even more excited about this.

A doctor having tinnitus and coming up with positive results after 10 years sounds just too big for just another scam.

But well, you never know.

I'm sure there's a name for that sort of fallacy, i.e. personally affected ==> better results. No-one's saying this is a scam, but if the methods to show efficacy are inadequate, then that is a major concern.

P.S. I don't know if Dr. Shore has tinnitus or if you're just projecting - I don't care, FTM.

 

[prowlinacage]

Considering Dr. Shore has tinnitus herself, it makes me even more excited about this.

Really?! Huh. In all my reading about her and listening to her, I never knew that. I like knowing she has some skin in the game and it makes even more sense that she would be super, extra rigorous about trial design, analysis, and not over-sharing before peer review.

 

[dd314]

Exploring what "somatic" really means in the context of tinnitus is going to be quite a rabbit hole.

It's cool that even the audio-only stimulation decreased tinnitus by 5 dB. That might be good news for the non-somatic people.

 

[Mathew Gould]

TFI is so problematic that I largely discount it as a metric. But let me put a bit of a narrative on these numbers and theorize why that 15-20 point reduction in TFI is all we see from a 75% reduction in tinnitus loudness.

First of all, that reduction in TFI represents roughly a drop in one class of tinnitus distress; "not a problem (0 to 17), small problem (18 to 31), moderate problem (32 to 53), big problem (54 to 72), very big problem (73 to 100)"

If the average participant came in around a 50, they dropped from a borderline big problem to a borderline small problem.

This isn't insignificant. But again TFI is a really poor way to measure tinnitus, it measures our emotions about tinnitus. Though there is a life changing functional difference in a 75% reduction in tinnitus loudness for severe tinnitus sufferers (hearing, concentration, relaxation, lack of a pain response), an average person with average tinnitus in the study might still express irritation that they can hear it in a quiet room or that when they go to bed at night they need to put on a fan and the TFI captures their annoyance they need to listen to this sound at all. In short TFI, the measurement of how we feel about tinnitus, probably isn't linear, we can greatly reduce the volume yet still be troubled that there are phantom sounds at all.

Secondly, maybe the 30 weeks wasn't enough time to capture the habituation process for the new quieter tinnitus. I think, as a rule of thumb, we normally think of someone with 'normal tinnitus' taking 9-12 months to really get over the hump.

First of all, how did they measure a 75% reduction in tinnitus?

Secondly, my tinnitus is mostly reactive (goes up with TV, etc), is this device going to work for reactive tinnitus?

I can hear my tinnitus everyday, although I would say it only bothers me about 12 days out of the month. The annoying days are when it's in my head and the non-annoying days is when it's in either ear.

 

[Stanley Samwise]

my tinnitus is mostly reactive (goes up with TV, etc), is this device going to work for reactive tinnitus?

I can hear my tinnitus everyday, although I would say it only bothers me about 12 days out of the month. The annoying days are when it's in my head and the non-annoying days is when it's in either ear.

From my understanding all tinnitus is reactive to a certain degree, whether we actively notice it or not. I doubt it would be an exclusion criteria for whether or not the device was to work for you or not. But that's just my understanding.

 

[AfroSnowman]

I just thought of one more reason that TFI m

ow did they measure a 75% reduction in tinnitus?

They used a software program called Tinn Tester (or some name like that). You go in and match the pitch and volume of your tinnitus. Click, measurement is done. So as people were in the study over a 12 week period of time, their average tinnitus volume was matched at 75% less volume than when they began treatment.

If Dr. Shore's theory about the source of tinnitus being overactive synchronized fusiform cells is right and this treatment calms it down, I don't see a logical reason why reactive tinnitus would be any less affected by this treatment. But I'm just talking from a place of pure ignorance, I really have no idea.

 

[Tomas80]

If 75% reduction in tinnitus loudness is an average number, someone must have had an even bigger reduction. Mathematics... do I understand it correctly?

 

[Gb3]

If her theory is right about the DCN, it's only a matter of time before someone can stimulate it directly and completely eliminate tinnitus!

Not to derail this topic, but this is kind of what XEN1101 does.

I meant directly via a direct stimulation, not a pharmaceutical.

 

[Alue]

Well, hyperacusis is a far less studied condition and we know a lot less about it than tinnitus. It can take many different forms as I've read on this forum during the last 1.5 years that I've been here. Before it all began for me, I would have said that it's all misophonia and it's just psychological reasons that a person dislikes being around sound. I couldn't have imagined that there are actual pathological reasons and ear injury that would cause pain or increased perceived loudness of sounds.

In my experience, many doctors deal with it like they know better, patronising and even victimising us. For example, since my tinnitus onset, I have a weird vibrating/muscle twitching/TTTS sensation in my ears when I hear sudden noises or speaking to one person in relative quiet (doesn't happen always). With more noise around it just disappears. But still, it can become quite uncomfortable. Nearly all of the doctors I've seen, dismissed it as "there is no such condition". Well...

I don't think there is a solid diagnosis for hyperacusis or misophonia. There are some tests like LDL or so, but still they don't know show anything about what is really happening. *shrugs*

I've been dealing with hyperacusis since early 2016. Seen more than a handful of audiologists, ENTs, and a couple of otologists. I did the LDL test before, but that's pretty useless if you ask me, it's so subjective and of course I'm going to stop the test before you get to a volume that is going to cause me problems.

It's gotten worse over time. Loud noises and environments have created more tones, beeps, etc. that have not gone away. I've been loosing more and more of my high frequency hearing despite protecting my ears as much as reasonably possible.

I don't mean to scare other people that are new. Most don't deal with this. Sorry for getting off topic, I'm glad the Phase 2 was successful.

 

[Mathew Gould]

They used a software program called Tinn Tester (or some name like that). You go in and match the pitch and volume of your tinnitus. Click, measurement is done. So as people were in the study over a 12 week period of time, their average tinnitus volume was matched at 75% less volume than when they began treatment.

If Dr. Shore's theory about the source of tinnitus being overactive synchronized fusiform cells is right and this treatment calms it down, I don't see a logical reason why reactive tinnitus would be any less affected by this treatment. But I'm just talking from a place of pure ignorance, I really have no idea.

OK, so if Tinn Tester says my tinnitus is 60 dB and it gets reduced by 66%, my new tinnitus would then be 20 dB as measured by Tinn Tester, which is basically not even audible. This seems good to me.

 

[AfroSnowman]

Does anyone have an example of how long it takes the FDA to approve a novel device?

I've drunk the Kool-Aid, I believe this will be a significant difference-making treatment, now I really want to get my hands on one so I can get back to life ASAP.

 

[cjbhab]

OK, so if Tinn Tester says my tinnitus is 60 dB and it gets reduced by 66%, my new tinnitus would then be 20 dB as measured by Tinn Tester, which is basically not even audible. This seems good to me.

No. I think you'd get a 12 dB reduction so it is now 48 dB - but basically easily masked.

 

[Karen1979]

If 75% reduction in tinnitus loudness is an average number, someone must have had an even bigger reduction. Mathematics... do I understand it correctly?

They would use a standard deviation. For the standard normal distribution, 68% of the results lie within 1 standard deviation of the mean; 95% lie within two standard deviations of the mean; and 99.9% lie within 3 standard deviations of the mean.

This would have been spread over a bell curve. There will be outliers so a few with lesser reduction and a few with more reduction. 75% would have been the average.

 

[UKBloke]

Exploring what "somatic" really means in the context of tinnitus is going to be quite a rabbit hole.

 

[Lurius]

Considering Dr. Shore has tinnitus herself, it makes me even more excited about this.

Sorry to put you on the spot like this, I don't mean to question you, I'm just genuinely curious. But how do you have this information?

 

[Samwise_The_Loud]

My thoughts are with @AfroSnowman on the TFI point, I think dB reduction is a far more reliable metric to use and the incorporation of TFI is likely to assist on the FDA approval process.

For what it's worth, I don't believe this is a sham. Trust me, I actually bought and used Lenire. It made my tinnitus worse. I have every reason to doubt another device that is based on a similar premise, but Dr. Shore has been developing this for so many years and her theory of tinnitus is the best I have seen. The results seem comprehensive (at least on what was reported). Further, I would note the amount of funding raised in support of the Auricle company she is going to form.

This may be false hope, but it is hope nevertheless.

 

[AfroSnowman]

Hate to be optimistic, but looking on the chart of dB reduction over 12 weeks after a 6 week treatment, the trajectory hasn't flattened out at 12 weeks. There could very well be a continued decrease in perceived loudness beyond 12 weeks.

 

[Karen1979]

Hate to be optimistic, but looking on the chart of dB reduction over 12 weeks after a 6 week treatment, the trajectory hasn't flattened out at 12 weeks. There could very well be a continued decrease in perceived loudness beyond 12 weeks.

Also based on standard deviation, at least 10% of the participants would have a greater than 75% reduction... I like optimism.

 

[Nick47]

There could very well be a continued decrease in perceived loudness beyond 12 weeks.

@AfroSnowman, I think the effects lasted 30 weeks post treatment?

 

[JRC1]

So I offer this as a more of a question than an assertion.

Wouldn't Dr. Shore's numbers make sense (15-20 pt TFI reduction, 12 dB sound reduction) if the average participant had a TFI which was, say, in the 30s? I believe I read somewhere that the "average" dB of tinnitus is 20 dB. So, if the treatment was effective, and the TFI went from 35 to 18, and the 20 dB was reduced, would all this add up?

And, at least at this point, we don't know what the treatment would do for someone with severe tinnitus and/or hyperacusis?

 

[Markku]

@AfroSnowman, I think the effects lasted 30 weeks post treatment?

A few slides that weren't yet shared in the Palm Springs Hearing Seminar thread:

 

[UKBloke]

Though there is a life changing functional difference in a 75% reduction in tinnitus loudness for severe tinnitus sufferers (hearing, concentration, relaxation, lack of a pain response), an average person with average tinnitus in the study might still express irritation that they can hear it in a quiet room or that when they go to bed at night

Quite. Also, in a trial situation we can't rule out the effect of participants' pre-treatment expectations as a factor when filling out a psychological metric post-treatment.

Personally, as someone who's lived with tinnitus for 30 years, my expectation is such that I'm not looking for silence. A 75% reduction in volume, however, would be out-of-this-world. Quite frankly though, a 15-30% reduction would still make me ecstatic.

This is why we need to see the data for chronicity, and assess how those trial participants who are a few years into this have faired on an invidual basis before I think we can draw some more solid conclusions.

 

[Nick47]

Wouldn't Dr. Shore's numbers make sense (15-20 pt TFI reduction, 12 dB sound reduction) if the average participant had a TFI which was, say, in the 30s? I believe I read somewhere that the "average" dB of tinnitus is 20 dB. So, if the treatment was effective, and the TFI went from 35 to 18, and the 20 dB was reduced, would all this add up?

And, at least at this point, we don't know what the treatment would do for someone with severe tinnitus and/or hyperacusis?

I'm only going on the first trial, but average loudness was about 50 dB and average TFI 30. May be different in this Phase 2 trial but that was the baseline means from Phase 1.

 

[Kam75]

A few slides that weren't yet shared in the Palm Springs Hearing Seminar thread:

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My gosh, all this good news is really coming at the right time! It is coming at a time when my tinnitus is terribly intense and makes me sleep very little.

I'm not normally one to try a brand new treatment. I am a very suspicious person and a bit of a hypochondriac. But honestly if this device was already available, I think I would already be booking a plane ticket to the US.

If all this is true, I would love to see things move forward quickly and this blessed device be released soon.

Please keep sharing good news like this, you don't know how good it feels to read all this. I feel so lonely, physically/mentally ehxausted and isolated because of tinnitus.

My greetings and gratitude to the Tinnitus Talk team and to Susan Shore for doing the best for us.

 

[AfroSnowman]

@AfroSnowman, I think the effects lasted 30 weeks post treatment?

At least 30 weeks, but I wonder if impact of the treatment continued to improve with time. There is a downward slope that just stops being measured at 12 weeks, if that trend continues for 16 or 20 weeks the actual final impact of the treatment may be considerably greater.