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The results are remarkable, though the eligibility criteria for participants are more restrictive than in most trials. Taken at face value, the results suggest that the treatment is highly effective.

In the Dr. Shore device, the tone played matches the frequency of the tinnitus. This is not the case with the Lenire device. The Lenire team analyzed trial participants who, by chance, had tinnitus at the same frequency as the tone played by the device but found no improved response in these...

The Susan Shore device has generated a lot of press in the mainstream media, but the results for her device are nowhere near as convincing as the results from this study.

What I’d like to know is what percentage of chronic tinnitus sufferers meet the eligibility criteria for this treatment. Let’s say it’s 50%. If we take the results of this trial at face value, it’s fair to say the author has solved the problem of chronic tinnitus for 50% of the population. So...

The same author wrote this paper. The results show that the therapy does NOT work for those without residual inhibition. Interestingly, the results for the residual inhibition group were not as good/convincing as those in the paper under discussion. Perhaps he was more selective in the most...

I noticed a few things about the participants. They are all relatively young, ranging in age from 18 to 43, and their tinnitus frequency is tightly clustered around 6.2 kHz. The average duration of tinnitus was two years, with none lasting longer than four years. A few candidates had reverse...

Why didn’t they have a question at the end something like: “In either weeks 1-6 OR 12-17 you were subject to a low level electric shock. Which do you think it was?” And then compare what they thought with what actually happened. If the responses indicated that the participants couldn’t tell...

Maybe it has worked, and they’re delaying the publication of results until they can figure out how to protect their IP. :) There have been some recent articles on this therapy with a bit more information: Researchers Develop Headphones That May Treat Tinnitus by Rewiring the Brain The...

Some people say this and others say you need to wear hearing aids for a while for them to work. Would it be possible to set up an online question for this? Something like: I have used hearing aids, and they are benefiting me. A) The benefit was perceptible within less than 30 minutes of...

All these Lenire studies have one thing in common. That is, they cannot distinguish differences between the results of various arms. If they could show that one arm was statistically better than another, it would be conclusive proof that it is doing something. Instead, no matter how different...

According to this, the estimated study completion date is 2024-01-30. Not sure what the "estimated study completion date" actually means. I guess it could be the completion of the trial and the publication of the trial results could be subject to another timeline...

Last night my wife and I walked to a nearby neighnorhood mulberry tree for a good feed of mulberries (we used a torch as it was late). I woke this morning after a very good night sleep. And for the first time in quite a while I had a very engaging and vivid dream. Linking the two, I did some...

Does anyone know if Mirtazapine is the type of medication that can be taken ad hoc? Usually I know before going to bed when I am going to have a rough night sleeping (maybe once every 3 or 4 nights) and would be good if I could take it on these nights only (presumably this would help to reduce...

Yes, that's what she is saying. Clinical trial designs can be broadly classified into parallel and cross-over designs. In the parallel design one group of people get treatment A and one gets treatment B (one of which may be a placebo) and the impact on the patients are compared between groups...

It does seem like there is some science/rationale behind this approach. More information here: I'm hoping we get some info about the results of this trial soon. If it's successful, maybe someone on Tinnitus Talk who is good at electronics/soldering could set up a business shipping out...

Here are the results from the first trial. Seems like Group 2 did quite well in loudness, but not quite as good in TFI (although roughly comparable). Also notice the swift return to baseline.

Thanks for that, very helpful. Personally, I think it is quite a reduction. If I set my speakers so that the 0 dB matches my tinnitus loudness (something that is not easily done with precision), and then listen to the -10 dB file (or perhaps it should be -14 dB, refer to my post above) file, I...

Here are some observations and queries: 1) The total number of participants who completed the study according to protocol (the "PP" group) was 56, which represents quite a high drop-out/non-compliance rate (originally 99 participants). The sample size is not that large. 2) In numerous parts of...

Yesterday I worked as an electoral office during the NSW election here in Australia. It's a 1-off day job starting from 7:00 am and ending at around 11:00 pm. Most of the work is crossing off names and handing out ballot papers and then counting up the results. I was a bit apprehensive at the...

Not so easy as there are many treatments that "work" according to the scientific studies, but don't seem to work in practice. That's why forums such as these are valuable as they can provide a consensus (taking into account multiple perspectives) on the value of a treatment.

We found a clear relationship between perceived loudness and TFI when we looked at the cohort for the Lenire study. But I guess perceived loudness is not the same as loudness. I believe loudness can be measured reasonably objectively by asking the person afflicted with tinnitus if they can hear...

The cynic in me suggests that the closer a product gets to commercialisation, the more untethered the claims become...

I think we’ll need the full paper to come out to fully understand this graph. According to the graph, there were also people in the control arm who had similar increases. Maybe the device was not responsible for the increases. It could be that some people in the trial had tinnitus volume that...

Did you do any other tests other than hearing? What about THI or loudness tests?

Maybe the placebo group will get some music? I agree it’s not that simple as some types of treatment may induce a placebo response more than others. Much easier with a pill!

Maybe she's used it and it has improved her tinnitus (I understand that the device rarely eliminates tinnitus).

This p-value is for the correlation between the change in TFI and the change in loudness during the active phase. I don't think this is indicative of the effectiveness of the device? Also, not sure why there would be a significant correlation during the active phase but no significant...

Look at the green dots. These represent readings for people without the treatment. There are many more green dots on the left of the vertical line than the right. This means that TFI is improving. But there are about the same number of green dots below and above the horizontal line, meaning...

Yes, on some days I can hardly hear my tinnitus and on others it is quite bad. So, if I started the treatment on a good day, and then had a reading after the treatment on a bad day, the result could potentially be a lot worse, but maybe not as bad as it would have been without the treatment...

The graphic is interesting (source). It shows the loudness of the sham group being reduced by about 5 dB (almost 50%) at the end the 12 weeks period, and progressively improving. Maybe because most (?) of the trial participants have had tinnitus for less than 1 year and we are seeing...

The duration of the treatment was 6 weeks, so I guess this means that after the end of the treatment there was, on average, a 50% reduction in loudness, and during the next 6 weeks (with no treatment) there was, on average, additional loudness reduction of 50% (i.e. 50% of the remaining 50%, to...

Hi Manny, I raised the same issue quite a few pages back. It seems like showing that this issue has been overcome in the trial protocol is critical, but it's not mentioned anywhere in the original paper. Maybe they are seeing results because some people are detecting (maybe even subconsciously)...

You are right. There are so many studies out there for treatments which have positive, statisitically significant results, but which are not adopted because in practice they don't work (if they did, we'd have a batch of treatments endorsed by our national health authorities, which we don't, and...

TFI reduction of 10.1 for the control and 17.8 for the treatment. No significant statistical TFI reduction difference between the control and treatment arms. Seems like the control was a good one, with the only issue being the staff administering the trial were not blinded. If it does work...

Stop beating around the bush and tell us what you really think.

How about a double-blinded sham controlled positive result that is ALSO replicated by at least one set of independent researchers...! Would have knocked out Lenire (no control) and DeSyncra (probably not able to be replicated by an independent party - and unlikely that anyone would bother).

We’re lucky Penicillin was invented when it was as otherwise we might have been up for several hundreds of thousands for treatment by a wonder drug...!

No control again, however: “After obtaining the consent of the Office for Registration of Medicinal Products of the Republic of Poland, a randomized, double-blind, placebo-controlled clinical trial has been planned for a large population of 300 patients with subjective tinnitus in the period...

How did the testing go?

The other thing about Seoul is that it has very wide (and busy) roads in the city (apparently to facilitate tank access in the event of a war). To cross these roads, there are plenty of underground tunnels. When we arrived in Seoul a few years ago we weren't aware of the tunnels and crossed over...

Hi Toby. My understanding is rotating the headphones 180 won't work as this will also involve rotating the microphones and you will still hear external sound coming from the right in the right headphone. The idea behind this treatment is that you hear ambient sounds coming from the left in the...

Looking at the graphic in the original post, looks like you need to do it for at least 40 hours to start seeing some effect (the more the better). How did you get the mirror'ed headphones?

Oops, you are right. And no manufacturer is going to include the swap feature because (almost) no one will have a need for it (and it also could have safety issues). I wonder how hard it is to do this? These headphones aren’t cheap!

Wouldn’t it be easy enough to test this. You can buy headphones or earbuds with “ambient mode”, e.g. https://blog.taotronics.com/headphones/what-is-ambient-sound-mode-on-headphones/. Then just swap the left and right and see if it works...

There was an article about this in the mainstream press today (The Daily Telegraph in Sydney). Just a short article saying that 1 in 10 suffer from tinnitus and the Bionics Institute has developed a test which is 87% accurate...

Someone should do a study and write a learned paper on “Placebo effects in tinnitus trials”! Seems like they would have plenty of material.

We’ll need to wait for this to be sure it actually works. Let’s hope they can get it done quickly. Sounds promising.

I'm not buying it. As others have said, they could have done all the stats pre-work in advance and just plug in the numbers when they become available at the end of the trial. Probably would take no longer than an afternoon to determine whether the trial has been successful and to what extent.

I've thought about this as well. If the treatment was with a pill, you could even do blinding (e.g., someone from the forum sends out a batch of pills to participants which could either be placebo or the real deal). I think liability would be an issue though - what happens if the treatment...

I’ve made enquiries, but they’re too expensive. Around AUD $8k I think. Trial period is short, but you can get 3 months I think by paying refundable $2k. If they break/I lose them during the trial period, I’m down $8k. Maybe I’ll try some cheaper Specsavers ones later. The whole hearing aid...

I don't know. It's strange. There must be heaps of $$ to be made if it works. Maybe there is a reulctance because there is no drug which works for tinnitus despite many attempts and they have drawn the conclusion that as a consequence this one probably wont work either? Maybe people with...

Well, the article states: Age and tinnitus duration were also associated with poor clinical outcomes because of the likelihood of chronic maladaptive neuroplasticity and complex causes (for example, age-related hearing loss, cochlear cell degeneration, or psycho-emotional pathology) of auditory...

So many trials with positive results. So few available treatments that work…!

This looks like a very interesting treatment and hopefully it's legit! Especially interesting is that the results persist for at least the year after treatment. The data for the patients is presented with the article as an image. I've copied some of the chronic data for each patient from the...

Exactly. Trials/results without controls are fairly meaningless...

It looks promising to me, and it will be very interesting to see the results later this year. It’s a little strange that the original paper doesn’t mention the technique used to ensure the participants weren’t able to distinguish between the sham and treatment stages and the method of ensuring...

Neuromod have stated that 86% of participants who undertook the treatment in their trial saw an improvement. This stat only has meaning if all the participants in this 86% had a significant difference from a control that was above the MCID for the scale they used (which they didn't) and there...

Well, I've done a natural experiment by losing quite a bit of weight (got a few kilos to go). I'm now 75.9 kg (167 pounds for Americans) and my target is 74 kg. I've lost about 14% of my body weight. Below is weight graphs from 2012 to now (with a break while I was working overseas being the...

Could very well be due to a placebo effect. It could be that you are anticipating relief from your tinnitus from this new treatment, hence your stress levels are going down, hence your tinnitus is going down...

Yes, some go to 12 kHz, but typically these models area at the top of the range, and hence more expensive. For example, Oticon OPN 1 goes to 10 kHz. I tried a normal hearing aid without success, but thinking of trying a wideband version to see if it helps (as I think my tinnitus is around 9.6 kHz).