New University of Michigan Tinnitus Discovery — Signal Timing

[AmePerdue]

Just like Lenire, Tinnitus Retraining Therapy etc., etc.

All I want is to reduce my tinnitus loudness, I did my own habituation. So far only Auricle is promising in that aspect. Lenire isn't meant to reduce loudness, neither is TRT.

 

[BadNeighbors]

This article gives a pretty good explanation on the role of peer reviewers:

→ The Task of the Referee

I've never reviewed a medical science paper, but in the social sciences my job as a reviewer is to verify that the researcher's understanding of the established research, that their methods are sound and actually work for their research question, that they interpreted/analyzed their data properly, and then also small things like grammar, flow, and such.

Most papers are rejected from journals and it is very, very rare for a paper to be accepted when first submitted. The few papers that make it into a journal usually go through a revise and resubmit process.

The main reasons I suggest that an editor rejects a paper is because I believe that the methods are terrible and produced bad data or I believe that the data interpretation is so poor that I don't think the researcher is capable of fixing the problems.

However, I will ask the editor to ask the researcher to revise and resubmit if the data analysis doesn't answer all of my questions and I have faith that the researcher can provide this information. I will also suggest a revise & resubmit if the paper just has structure problems, despite the research being well done (not all researchers know how to write).

Addressing the question about approving papers reviewers don't agree with, I've only voted to accept one paper that I didn't agree with. However, this was a social science theory paper. I hated the theory that the author was discussing, but I couldn't deny that the paper was well done and the data supported their ideas. I requested that the author acknowledge key faults associated with the theory in their manuscript and told the editor that while I disagreed with the paper, it shouldn't be rejected, instead it should published so it could inspire debate.

However, theory papers are abstract, unlike something like Dr. Shore's recent paper. If it was 30 years ago and Dr. Shore was just thinking out loud saying, "I think if we shock people, it'll retrain the brain to shut up because of X, Y, and Z," a reviewer could disagree but accept it as it would create discussion in the community. But, since she is directly testing a hypothesis, I don't think a reviewer would say, "I disagree with your interpretation of the data, but I'll vote to accept it."

 

[T Toledo OH]

Besides @linearb, was anyone else on Tinnitus Talk part of the Auricle trial?

 

[awake 44]

All I want is to reduce my tinnitus loudness, I did my own habituation. So far only Auricle is promising in that aspect. Lenire isn't meant to reduce loudness, neither is TRT.

I feel the same. I did what I could to habituate. I've been doing TRT for a year and a half now. All I can say TRT helped a little bit and I learned how to minimize the impact of tinnitus on my life. But TRT does not cure, and I find Jastreboff almost a sadist, as he thinks achieving silence will never be possible.

 

[Cernuto]

View attachment 55135

I'm a little surprised how simple the audio/electrical stimulation waveforms look. This is not a difficult thing to do from an engineering perspective. What does look difficult is the calibration.

It looks to me calibration includes factoring in the participant's audiogram, and the participant's ability to match their tinnitus. Given the variability inherent in these parameters for those of us whose tinnitus changes daily, I believe proper calibration will present some challenges. Meaning, it will require a few visits to get our calibrations right.

Best scenario is a highly-qualified audiologist with open flexibility in their appointment schedule, who has plenty of patience, skillful guidance, and the proper equipment to detect 'hidden hearing loss'.

 

[Cernuto]

One thing I've noticed about dB is that's quite a varied and confusing scale/system. There's sound pressure levels (literally the pressure of sound moving through air) and then there's perceived volume, which don't appear to be the same thing.

Then there's this inverse square law thing going on when it comes to a halving (or 6 dB reduction) of volume, which is why I'm not convinced by @Gabriel's analogy of knocking a 40 dB fader back to 37 dB. It's not the same as a 3 dB reduction in perceived volume - well, to my understanding at least!

In time hopefully we can get more info, perhaps from Dr. Shore herself, about how patients' hearing perceive these dB figures in real-world use.

I may be wrong, but gathering from the device's study, you are not being barraged with a continuous, loud audio tone. The audio stimulation signal only lasts for 10 milliseconds, followed by 10 seconds of silence. 10 milliseconds of audio is barely anything relative to 10 seconds. I mean it's going to be barely perceptible as anything other than a chirp. So, every ten seconds you'll hear a very brief chirp, almost like a click. Packed in that chirp is your tinnitus frequencies corrected for your hearing loss. The chirp is almost immediately followed up by an electrical stimulus to your jaw or neck, which is also very brief.

 

[Karl Tallman]

I have read most of the recent pages on this thread but didn't see this topic discussed.

Does anybody have any knowledge or insight if Dr. Shore's device will be effective for those that have difficulty matching the frequency of their tinnitus because it's above 8 kHz and they also have moderate-to-severe hearing loss above 8 kHz, making it difficult to mask or even identify the frequency of their tinnitus?

If you can't hear the audio stimulation signal timed with the electrical stimulation due to severe hearing loss from 8 kHz to 10 kHz (50-60 dB in my case) and profound loss above 10 kHz, can this treatment still work?

 

[ErikaS]

I have read most of the recent pages on this thread but didn't see this topic discussed.

Does anybody have any knowledge or insight if Dr. Shore's device will be effective for those that have difficulty matching the frequency of their tinnitus because it's above 8 kHz and they also have moderate-to-severe hearing loss above 8 kHz, making it difficult to mask or even identify the frequency of their tinnitus?

If you can't hear the audio stimulation signal timed with the electrical stimulation due to severe hearing loss from 8 kHz to 10 kHz (50-60 dB in my case) and profound loss above 10 kHz, can this treatment still work?

I think to be most effective, you need to be able to hear the sound stimulus that best matches your tinnitus in at least one ear. The inclusion criteria for the trial stated "no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies." However, it is still a little unclear how "exact" the auditory stimuli needs to be for your tinnitus sound, especially for those of us who have variable multiple sounds. Let's say you'd describe your sound above 10 kHz and like a hiss, which is considered wide band noise-like. Because you cannot hear at 10 kHz and up, is it possible to play 6 kHz at wide band noise and get some positive effect? I'm not sure. I just often go back in my mind to what @linearb shared with us about the first trial and how not only was the input sound not completely and exactly specific to one of his tinnitus sounds, but it worked and it lowered his tinnitus sounds volume and intrusiveness as a whole.

 

[Nick47]

If you can't hear the audio stimulation signal timed with the electrical stimulation due to severe hearing loss from 8 kHz to 10 kHz (50-60 dB in my case) and profound loss above 10 kHz, can this treatment still work?

I'm in a similar but possibly worse situation. My left ear is normal between 250 Hz - 8000 Hz, my right ear has severe-profound hearing loss from 4000 Hz onwards.

Nobody knows the answer to your question, unfortunately.

I do know you only wear one ear piece with the device. Do you have bilateral hearing loss? If you scroll back 10-15 pages, around December 2022, Dr. Shore said you only wear one ear piece because tinnitus is in the brain and contralateral pathways influence the other side.

 

[UHPTS]

The audio stimulation signal only lasts for 10 milliseconds, followed by 10 seconds of silence. 10 milliseconds of audio is barely anything relative to 10 seconds.

Could you please point me to the document where you got this information from? Thanks.

 

[annV]

Could you please point me to the document where you got this information from? Thanks.

It's in the eFigure 2 under "supplemental content".

 

[UHPTS]

The audio stimulation signal only lasts for 10 milliseconds, followed by 10 seconds of silence. 10 milliseconds of audio is barely anything relative to 10 seconds.

I'm looking for that 10 second delay really hard but can't find it bro. From the diagrams it looks more like 85 ms or 150 ms. Hard to tell. There are two diagrams that reveal signal content and some mention in the text. The diagrams are different though so it is bit of a guesswork to figure out what is the signal progression.

 

[Cernuto]

I'm looking for that 10 second delay really hard but can't find it bro. From the diagrams it looks more like 85 ms or 150 ms. Hard to tell. There are two diagrams that reveal signal content and some mention in the text. The diagrams are different though so it is bit of a guesswork to figure out what is the signal progression.

Like I said, I may be wrong, and after reviewing it again, it looks like I was wrong. I got the 10 seconds from here, under the Intervention section:

Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

It says: "Open-circuit and short-circuit checks for all treatments were performed, with subthreshold electrical stimulation delivered every 10 seconds during the treatments."

So, after reviewing, it looks like circuit checks are performed every 10 seconds, possibly interleaved with the treatment. My apologies for my confusion. I'm even more confused now after seeing this other figure here:

It clearly shows the electrical stimulus preceding the audio, which is the opposite of what's explained in the text that follows it: "...spectrum is digitized and programmed into the device as the signal to be delivered to the subject. The amplitude is limited to 95 dB SPL and is delivered together with an electrical stimulus delivered a short time after the auditory stimulus..."

Also note the chart extends out to 200 milliseconds.

 

[dj_newark]

This is what Bard (Google's Generative AI similar to ChatGPT) has to say about the FDA approval for a Class 2 510(k) submission:

The FDA's goal is to make a decision on a 510(k) submission for a class 2 medical device within 90 days. However, the actual time it takes to get approval can vary depending on the complexity of the device and the completeness of the submission. In some cases, the approval process can take longer than 90 days.

Here are some factors that can affect the approval time for a 510(k) class 2 medical device:

• The complexity of the device. The more complex the device, the more time it will take for the FDA to review the submission.
• The completeness of the submission. If the submission is incomplete or missing important information, the FDA will need to request additional information from the manufacturer. This can delay the approval process.
• The workload of the FDA. The FDA's workload can fluctuate, and if the agency is understaffed, it may take longer to review submissions.

If you are a manufacturer of a class 2 medical device, there are a few things you can do to help ensure that your 510(k) submission is reviewed and approved as quickly as possible:

• Make sure your submission is complete and accurate. The FDA will not review a submission that is incomplete or missing important information.
• Work with a qualified consultant. A qualified consultant can help you prepare your 510(k) submission and ensure that it meets the FDA's requirements.
• Be patient. The FDA's approval process can take some time, but it is important to be patient and work with the agency to ensure that your device is safe and effective.

As for the first and second bullet points in the second part of this message, Dr. Shore and her team has this covered. No one is more accurate, efficient and comprehensive in their documentation than her. And we know that they have a qualified FDA specialist on the Auricle team. She revealed that during the Palm Springs Hearing Seminar late last year.

I'm hoping to hear of FDA approval soon, but I think the device being approved this year is a very safe bet.

 

[IndyMLVC]

I'm hoping to hear of FDA approval soon, but I think the device being approved this year is a very safe bet.

Apologies if this was already answered but, once Dr. Shore's device achieves FDA approval, how long after that can the manufacturing begin? Or can they legally begin manufacturing beforehand if they're sure of approval so that they can be immediately ready for distribution?

 

[dj_newark]

Apologies if this was already answered but, once Dr. Shore's device achieves FDA approval, how long after that can the manufacturing begin? Or can they legally begin manufacturing beforehand if they're sure of approval so that they can be immediately ready for distribution?

I think that's impossible to say without more knowledge of manufacturing which I certainly don't have. However, I think no company in their right mind, either large or small, would begin manufacturing a medical device before it was approved by the FDA. No matter how confident they'd be in its approval!

 

[Ngo13]

I think that's impossible to say without more knowledge of manufacturing which I certainly don't have. However, I think no company in their right mind, either large or small, would begin manufacturing a medical device before it was approved by the FDA. No matter how confident they'd be in its approval!

I work in medical device manufacturing. Usually, the submission to FDA would have required a small validation batch to be manufactured in order to perform the required studies and generate the data used to qualify the device. Companies may choose to sell the devices part of the validation batch, but large scale manufacturing usually doesn't start until FDA approval because of the capital risk. There's a bunch of requirements a manufacturing site has to meet before it can begin manufacturing (separate from device regulatory approval), which also may include an audit from the FDA.

Hopefully, the people at Auricle have already been getting the necessary framework (validated equipment, approved suppliers, QMS, staff) and FDA site registration required so as soon as the device is approved they can begin manufacturing.

 

[Jonno02]

I work in medical device manufacturing. Usually, the submission to FDA would have required a small validation batch to be manufactured in order to perform the required studies and generate the data used to qualify the device. Companies may choose to sell the devices part of the validation batch, but large scale manufacturing usually doesn't start until FDA approval because of the capital risk. There's a bunch of requirements a manufacturing site has to meet before it can begin manufacturing (separate from device regulatory approval), which also may include an audit from the FDA.

Hopefully, the people at Auricle have already been getting the necessary framework (validated equipment, approved suppliers, QMS, staff) and FDA site registration required so as soon as the device is approved they can begin manufacturing.

Agree. I would assume Auricle's manufacturing contractor already have ISO 9001 and 13485, at least, so after approval it'll be smooth sailing for manufacturing.

 

[AfroSnowman]

I work in medical device manufacturing. Usually, the submission to FDA would have required a small validation batch to be manufactured in order to perform the required studies and generate the data used to qualify the device. Companies may choose to sell the devices part of the validation batch, but large scale manufacturing usually doesn't start until FDA approval because of the capital risk. There's a bunch of requirements a manufacturing site has to meet before it can begin manufacturing (separate from device regulatory approval), which also may include an audit from the FDA.

Hopefully, the people at Auricle have already been getting the necessary framework (validated equipment, approved suppliers, QMS, staff) and FDA site registration required so as soon as the device is approved they can begin manufacturing.

So if their ducks are in a row so to speak, how long do you figure it should take to get something like this to begin manufacturing after FDA approval?

 

[awake 44]

So if their ducks are in a row so to speak, how long do you figure it should take to get something like this to begin manufacturing after FDA approval?

Again, all we do here is speculating.

When it comes to the parameters and the way the device works, that is a good exercise, as we have a lot of official data.

When it comes to the business side, we have almost zero insights. Let's wait for the interview with Dr. Shore. I'm only saying this because such speculation results in focusing too much on stuff we have no control over.

 

[BobbieJay-1954]

I'm a long time lurker of this thread and I wanted to stop by and drop off my two cents.

I have mild tinnitus and it's been manageable for quite some time but these last few weeks have been particularly bothersome. I've seen people not only here but also in my personal life struggle with tinnitus and I couldn't imagine the pain of hearing it over pretty much everything. The shower and driving in a car EASILY mask mine so I am very fortunate. I'd say sleep is the most challenging part but an oscillating fan on mode 2 and Melatonin seems to do the trick.

I know that some people have their doubts about the efficacy of Dr. Shore's device but I am very optimistic that it will help a large portion of us. It would help out mild sufferers like me for sure but those with debilitating tinnitus NEED this. It could become a life saver - literally. Maybe it'll reduce it by a little bit... maybe a lot. Maybe entirely! Who knows? All I know is that your skepticism and concerns are completely valid.

Looking to the future and seeing a glimmer of hope like this is very comforting. It's nice to know that there are people out there who are acknowledging our pain, have actually worked towards a research based treatment and are weeks / months away from approval.

I've seen all the jokes about Dr. Shore tattoos and whatnot but if this device works, there will be celebrations like no tomorrow. No longer will we have to suffer in silence. We can finally claim it back to ourselves.

Stay strong everyone. Don't give up the fight just yet.

 

[Karl Tallman]

I'm also optimistic that this is finally the breakthrough we've been waiting for and that Dr Shore's device will help millions of tinnitus sufferers to some degree. It's also exciting that other tinnitus researchers could piggyback on her findings and fine tune it making it even more effective in the future.

I just don't understand why, when several years ago Dr Shore's animal trials concluded and showed that this could be an effective and promising treatment for reducing tinnitus in humans, the US VA, other countries and other tinnitus support organizations didn't kick in millions of dollars in funding to assist with this research?

I read that the US VA spends over a billion dollars a year for tinnitus disability claims alone, yet doesn't step up to contribute funding to a possible major breakthrough in tinnitus treatment?

With more funding and collaboration, the University of Michigan could have run human trials on thousands of people with varying causes of tinnitus. They could have run trials with just veterans with varying degrees of tinnitus and hearing loss and have a much better understanding of what types and degrees of tinnitus this treatment will be most effective in reducing. Instead we get a trial with just 99 people and a narrow set of tinnitus parameters.

I don't understand why there wasn't much more collaboration years ago when this path of treatment showed great promise? So frustrating.

 

[AfroSnowman]

I'm also optimistic that this is finally the breakthrough we've been waiting for and that Dr Shore's device will help millions of tinnitus sufferers to some degree. It's also exciting that other tinnitus researchers could piggyback on her findings and fine tune it making it even more effective in the future.

I just don't understand why, when several years ago Dr Shore's animal trials concluded and showed that this could be an effective and promising treatment for reducing tinnitus in humans, the US VA, other countries and other tinnitus support organizations didn't kick in millions of dollars in funding to assist with this research?

I read that the US VA spends over a billion dollars a year for tinnitus disability claims alone, yet doesn't step up to contribute funding to a possible major breakthrough in tinnitus treatment?

With more funding and collaboration, the University of Michigan could have run human trials on thousands of people with varying causes of tinnitus. They could have run trials with just veterans with varying degrees of tinnitus and hearing loss and have a much better understanding of what types and degrees of tinnitus this treatment will be most effective in reducing. Instead we get a trial with just 99 people and a narrow set of tinnitus parameters.

I don't understand why there wasn't much more collaboration years ago when this path of treatment showed great promise? So frustrating.

I'm pretty sure that she was in part VA funded.

 

[dj_newark]

I'm pretty sure that she was in part VA funded.

Both the ATA and NIH funded Dr. Shore's studies in part. But to what extent is not known. Had they both not put so much into the "wishful thinking" tinnitus treatments, like TRT, I can almost guarantee they would have put more into funding her studies.

 

[Bambam0]

I don't understand why there wasn't much more collaboration years ago when this path of treatment showed great promise? So frustrating.

You also have to remember that a system propped up to support $1B worth of annual claims has good reason to keep that 'system' in place. You know, for their own benefit!

 

[Gb3]

With more funding and collaboration, the University of Michigan could have run human trials on thousands of people with varying causes of tinnitus. They could have run trials with just veterans with varying degrees of tinnitus and hearing loss and have a much better understanding of what types and degrees of tinnitus this treatment will be most effective in reducing. Instead we get a trial with just 99 people and a narrow set of tinnitus parameters.

I don't understand why there wasn't much more collaboration years ago when this path of treatment showed great promise? So frustrating.

@Karl Tallman, I think initially they were planning a 400 person trial but then COVID-19 happened.

 

[Karl Tallman]

@Karl Tallman, I think initially they were planning a 400 person trial but then COVID-19 happened.

Darn! 400 participants would have given us much more insight into the effectiveness of the treatment. Damn COVID-19!

Thanks for the information!

 

[dd314]

Where are we on the question of what qualifies as somatic tinnitus? Dr. Shore's trials only recruited people with this pseudo-etiology, but she never actually tested the device on "non-somatic" tinnitus, did she?

Like many here, my tinnitus is from an acoustic trauma and did not present with any somatic components — until one day, when I bit into a piece of sandy broccoli and heard an ominous "ping" sound, and was thereafter given a new sound that I could modulate by opening and closing my mouth. This new sound virtually disappeared after 5 months, leaving me with only "non-somatic" (???) tinnitus.

I've also had yawns trigger TTTS because the middle ear muscles are all controlled by a branch of the trigeminal nerve, and it runs directly through the TMJ. The reason that so many of us get hyperacusis (not noxacusis) after an acoustic trauma is that the brain lowers the the acoustic-reflex threshold because the auditory pathway is injured, and it send this signal via the mandibular branch of the trigeminal nerve (one of Dr. Shore's stimulation points).

So, what are the odds of a person having both types of tinnitus? It seems like too much of a coincidence...

If tinnitus is really generated from overly excited fusiform cells in the DCN, as Dr. Shore claims, then it shouldn't matter how aligned your facial nerves are; it's not really a separate etiology. Is tinnitus fundamentally just one thing?

 

[dj_newark]

Where are we on the question of what qualifies as somatic tinnitus? Dr. Shore's trials only recruited people with this pseudo-etiology, but she never actually tested the device on "non-somatic" tinnitus, did she?

Like many here, my tinnitus is from an acoustic trauma and did not present with any somatic components — until one day, when I bit into a piece of sandy broccoli and heard an ominous "ping" sound, and was thereafter given a new sound that I could modulate by opening and closing my mouth. This new sound virtually disappeared after 5 months, leaving me with only "non-somatic" (???) tinnitus.

I've also had yawns trigger TTTS because the middle ear muscles are all controlled by a branch of the trigeminal nerve, and it runs directly through the TMJ. The reason that so many of us get hyperacusis (not noxacusis) after an acoustic trauma is that the brain lowers the the acoustic-reflex threshold because the auditory pathway is injured, and it send this signal via the mandibular branch of the trigeminal nerve (one of Dr. Shore's stimulation points).

So, what are the odds of a person having both types of tinnitus? It seems like too much of a coincidence...

If tinnitus is really generated from overly excited fusiform cells in the DCN, as Dr. Shore claims, then it shouldn't matter how aligned your facial nerves are; it's not really a separate etiology. Is tinnitus fundamentally just one thing?

I think the only reason it was tested on somatic tinnitus is because she's determined that group is most likely to benefit from her treatment. It doesn't mean that it doesn't work for other kinds, only that it hasn't been observed to. And she's too much of a methodical scientist to make claims about what she hasn't observed directly. We'll know more, of course, once the device is released about whether it works for other kinds. There will be more studies after it's been released, and she's said she will try to get the device to work more effectively for the types it already does and get it working for other kinds of tinnitus as well.

 

[AfroSnowman]

I think the only reason it was tested on somatic tinnitus is because she's determined that group is most likely to benefit from her treatment. It doesn't mean that it doesn't work for other kinds, only that it hasn't been observed to. And she's too much of a methodical scientist to make claims about what she hasn't observed directly. We'll know more, of course, once the device is released about whether it works for other kinds. There will be more studies after it's been released, and she's said she will try to get the device to work more effectively for the types it already does and get it working for other kinds of tinnitus as well.

Where did you get the information about her working in further improvements to the treatment?