Member- Jul 7, 2020
- 403
- Tinnitus Since
- 05/2020
- Cause of Tinnitus
- Unknown/Stress
Yes, there is a dramatic decrease in efficacy as regards reducing tinnitus loudness once treatment is stopped.
New University of Michigan Tinnitus Discovery — Signal Timing
- Thread starter Hudson
- Start date
Going through these graphs again gives me some doubts.
What I don't understand about these graphics is that in A+C, during placebo washout, there is an increase higher than baseline in TFI and loudness. This suggests to me there is a chance of worsening if the parameters are not set up correctly? But this is not reflected in B+D where there is a minor positive placebo affect? The graphs should be showing more or less the same?
Placebo did not have the electric shocks, right?
- Jul 7, 2020
- 403
- Tinnitus Since
- 05/2020
- Cause of Tinnitus
- Unknown/Stress
Going through those graphs gives me immense hope regarding tinnitus loudness reduction. Active outperforms Placebo by a wide margin.
I'd also imagine if you had a dramatic reduction in tinnitus loudness that, when it returns to 'baseline' after discontinuation of treatment, it might appear psychologically 'louder'.
Anyway. Hopefully we can just use this device indefinitely.
Absolutely I'm positive, but the risk of worsenings, whether psychologically or not, is there with sound treatment. Whether it is white noise, hearing aids, etc.
Last week, on their website, the British Tinnitus Association published their advice on Lenire, and they said:
Potential negative consequences
About one third of people reported exacerbation of tinnitus but for most this seemed to resolve by the end of the study.
I'm still bullish either way but I'm speculating Auricle might have the same safety profile as Lenire.
Does anyone have any kind of estimate on how long it takes to publish a scientific paper like this? I know it's a long shot but this is my last hope and if this fails like OTO-313... I'm trying to not get butterflies about this but I'm at the end of my rope here.
- Jul 7, 2020
- 403
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- 05/2020
- Cause of Tinnitus
- Unknown/Stress
Similar situation here. No one knows unfortunately. Prof. Shore said we must be 'patient'.
- Jul 16, 2019
- 89
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Unknow. Maybe stress?
BrysonKingMe
Member
- Mar 31, 2022
- 238
- Tinnitus Since
- 2016
- Cause of Tinnitus
- Paradoxical on Klonopin leading to a shitton of other proble
3 things:
1. The average TFI was relatively low in the first study. Too lazy to look it up but it was hovering around 30-40 I think? Might be wrong, but that is a 50% reduction in TFI. That is not small.
2. I agree with Padraigh, the chart lines up to exactly what you would expect. Once the actual treatment stops, the TFI goes above the baseline. Imagine you had dramatically quieter tinnitus for a week, then all of the sudden it went back to normal. I think anyone would show more distress than their baseline showed.
3. I think any severe tinnitus sufferer would be okay using a device every day for the rest of their lives for relief.
- Oct 31, 2020
- 1,254
- Tinnitus Since
- 9-17-2020
- Cause of Tinnitus
- turning everything up to 11
On the original trial it was stated that none of the participants experienced any worsening:
"No patient experienced a worsening of symptoms or quality of life, or other adverse events. Some said their phantom sounds got less harsh or piercing, or became easier to ignore." [source]
AfroSnowman
Member
- Jul 23, 2019
- 1,075
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- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
I think it was two different groups, one received the treatment and then sham, one received sham and then treatment.
On the chart it is differentiated; one line is dotted, the other is solid.
AfroSnowman
Member
- Jul 23, 2019
- 1,075
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- 04/2019
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- Jul 7, 2020
- 403
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- 05/2020
- Cause of Tinnitus
- Unknown/Stress
This device is NOTHING like Lenire.
Lenire does not target any physiological cause of tinnitus. The University of Michigan device does.
Yes there was no worsening. One poster was quoting from the recent Lenire TENT-2A trial where approx one third had a worsening of their tinnitus.
Can we just forget about Lenire really.
I've met Dr. Brendan Conlon and whilst he was a lovely man, he does not have a fraction of the publication history of Professor Shore's team. He is a practicing ENT, not a researcher and whilst Hubert Lim has been brought aboard to help refine the treatment it remains essentially the product of Dr. Conlon's initial research.
Above all Lenire does not attack a physiological proven source of tinnitus like the University of Michigan device.
If people can't see anything but positives from that chart I posted then they need to keep looking.
Results vs sham are quite good.
@BrysonKingMe, the starting TFI was 29 points. 10 patients had a greater than 13 point reduction.
Also, let's not forget that this was a clinical trial for four weeks.
In the real world application of this device it will be possible to refine and change the parameters mid treatment to a set that may be better for you.
This option was not present in the clinical trial to my knowledge.
Trial and error can occur. Maybe with slight adjustments to the positioning of the electrical stimulus and sound timings the other patients might have achieved similar results.
Only time will tell.
I'm Shore it will work
- Oct 31, 2020
- 1,254
- Tinnitus Since
- 9-17-2020
- Cause of Tinnitus
- turning everything up to 11
Here is also table data from the same Phase 1 clinical trial. This is not from the new, more recent clinical trial.
TFI for groups 1, 2, and the total of the two groups together.
TFI - First 3 columns represent the data from the same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the second arm (received sham treatment before active treatment).
Tinnitus loudness for groups 1, 2, and the total of the two groups together.
Tinnitus loudness - First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).
Serious adverse events.
19 patients: age 18 - 65 years
1 patient: >= 65 years
6 female
14 male
[source ]
TFI for groups 1, 2, and the total of the two groups together.
TFI - First 3 columns represent the data from the same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the second arm (received sham treatment before active treatment).
Tinnitus loudness for groups 1, 2, and the total of the two groups together.
Tinnitus loudness - First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).
Serious adverse events.
19 patients: age 18 - 65 years
1 patient: >= 65 years
6 female
14 male
[source ]
- Jul 16, 2019
- 89
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Unknow. Maybe stress?
We don't know when it will be, but one day there will be a time when Dr. Shore's device will be a pile of scrap, because there will be effective medicines for tinnitus. What a paradox...
AfroSnowman
Member
- Jul 23, 2019
- 1,075
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- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
Hopefully you are right, but if Dr. Shore's device can help us make things more tolerable while we wait years (decades) for a cure, it will be a god send.
Personally hoping for either cybernetic ears or regeneration/stem cells to be so effective that we can reconstruct the human hearing apparatus from end to end.
Hopefully Dr. Shore's device will help lead us in that direction.
I wonder how much Dr. Shore's device is going to cost. And how easy it will be to buy it in Europe.
I hope the brain doesn't get used to the pattern in Dr. Shore's device, so that the effect gets reduced in time. Like happens with Lenire. That was the reason why Neuromod changes the parameters in Lenire after 6 weeks of treatment.
What do you think?
What do you think?
- Jul 7, 2020
- 403
- Tinnitus Since
- 05/2020
- Cause of Tinnitus
- Unknown/Stress
So true.
I just think there is no comparison between Dr. Shore's device and Lenire.
Lenire does not target a physiological cause of tinnitus.
In fact the evidence we have from Phase 1 tentatively suggests that Dr. Shore's device will calm those fusiform cells more with continued usage.
I think you are trying to sew doubts about Dr. Shore's device and make up stories, much like you did on the Lenire device. People can look at your posts and see that for themselves. You called Lenire "like using Russian roulette," among other overly negative posts.
Lenire worked for some on Tinnitus Talk, and not for others, disregarding the people outside of Tinnitus Talk that used the device. Just like Dr. Shore's device will probably work for some, and not for others who do not indicate for it.
If the majority on Tinnitus Talk report that Dr. Shore's device works, then I'm not waiting for EU availability. I'll fly to North America immediately, if that's what it takes to get the device.
Dude, I'll be in the seat next to you and high fiving us, crossing my fingers and holding your hand. I already flew to Dublin for Lenire, I can definitely fly to USA for this.
- Jul 16, 2019
- 89
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Unknow. Maybe stress?
I fly with you. We'll fly back to Munich, then we'll celebrate at the Oktoberfest, you're invited to my place.
At this point we should just charter a private Airbus A380 from somewhere in Europe to the USA.
The average hourly rental rate of the Airbus A380 is only around 37,150 USD per hour. Surely we could crowdfund this.
The average hourly rental rate of the Airbus A380 is only around 37,150 USD per hour. Surely we could crowdfund this.
What are we thinking on timelines for this?
Rest of 2022 to analyse the data. January-July 2023 to publish results. September 2023 to finish peer review and publish.
Rest of 2022 to analyse the data. January-July 2023 to publish results. September 2023 to finish peer review and publish.
- Dec 18, 2015
- 618
- 45
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- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
Didn't Dr. Susan Shore say she will not publish the results prior to peer review?
God I hope it will be faster than your estimation. Especially the peer review could start beginning next year. But I don't have a clue how long such things might take.
Hoping they release the device in 2023!
Once Dr. Shore releases the device, it will be copied quite readily from China. My guess is Auricle will sell it for $4,000 to $6,000, some dude in China will buy one, and then mass produces it. All I am saying is there is no need to restrict the finding of the research.
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