New University of Michigan Tinnitus Discovery — Signal Timing

[GregCA]

Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking sound like a white noise through headphones and gradually increase the level until it covers the sound of your tinnitus. However, for some, like myself, tinnitus can be unmaskable. That's how they go about it in these medical trials and an audiologist who knows about tinnitus can also do this for you.

MML is a different characteristic of your tinnitus. It can also be established, but it doesn't have to match your tinnitus volume.

Here is some more info on how to match pitch & volume:

ENT and Audiology News: Measuring the Pitch and Loudness of Tinnitus

Basically, it's through comparison of similar stimuli (not through masking). There are other resources online that explain this process.

 

[AmePerdue]

Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking sound like a white noise through headphones and gradually increase the level until it covers the sound of your tinnitus. However, for some, like myself, tinnitus can be unmaskable. That's how they go about it in these medical trials and an audiologist who knows about tinnitus can also do this for you.

Are some tones more maskable than others?

How do they account for day-to-day fluctuations or natural spikes that can be weeks or even months long?

 

[Fightthearmy]

Need to be realistic and look at all options, and not hang our hat on just one.

I'm currently looking at religion, self-help books, Propofol, strong liquors, and fire. These are the realistic options to look at, near-term.

But it's been a decade. A decade.

Very strange and ambiguous the way you phrase "It's been a decade". Is English your first language?

 

[Forever hopeful]

Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking sound like a white noise through headphones and gradually increase the level until it covers the sound of your tinnitus. However, for some, like myself, tinnitus can be unmaskable. That's how they go about it in these medical trials and an audiologist who knows about tinnitus can also do this for you.

Except relatively quiet, but very high frequency tinnitus may also be very difficult to mask but not necessarily considered loud. That is my case.

 

[Bhaveen]

Hi all. Thank you @Markku and @Hazel for getting the Q&A done. It's really helpful.

Sorry if I'm asking something that is easy to spot, but are the results saying that only 65% of those in the study experienced symptom relief? From my knowledge, everyone on the first trial had symptom relief so I'm surprised if only 65% achieved it here in the second study.

I appreciate any comments. Thank you.

 

[Guywithapug]

 

[kingsfan]

Very strange and ambiguous the way you phrase "It's been a decade". Is English your first language?

"It's been a decade" sounds like proper English to this American.

 

[BTaylor12]

Very strange and ambiguous the way you phrase "It's been a decade". Is English your first language?

It's been a decade is fairly self explanatory. Or let's just say "10 years"?

 

[dj_newark]

I'm currently looking at religion, self-help books, Propofol, strong liquors, and fire. These are the realistic options to look at, near-term.

Very strange and ambiguous the way you phrase "It's been a decade". Is English your first language?

That's a completely normal use of the English language. Where are you from?

 

[StoneInFocus]

Bro.

You say you have had tinnitus since last year.

By the time this device comes out, your tinnitus could already be 10 dB lower or you could be completely habituated to it.

As Dr. Shore has said, "the goal is to return to a state in which people can function well."

Let's try to put things in perspective.

 

[F-u-T]

I believe Dr. Shore has been working on this research for close to 20 years now.

 

[Kaoru]

Sorry if I'm asking something that is easy to spot, but are the results saying that only 65% of those in the study experienced symptom relief?

Not exactly.

The study says:

The responder analysis showed that more than 65% of the PP population and more than 55% of the ITT population who received bisensory treatments had TFI score reductions that were clinically significant (≥13 points decrease from baseline) and remained constant during the active washout phase.

Tinnitus level is subjective. So when a patient declares having minor improvement, you can not be sure if it is an actual improvement or placebo effect. That's the reason behind the 13 points rule in this study.

You only have 65%, but at least, you can be confident that it is not placebo. For the remaining 35%, we can not be sure. But it seems pretty reasonable to think that some of them, if not most of them, experienced some relief as well at a more modest level or for a shorter span of time.

Also, the curves of the TFI score reduction seems to suddenly break at the end of treatment. This suggests the results could be even better if the treatment period was longer.

 

[SarahMLFlemmer]

You say you have had tinnitus since last year.

By the time this device comes out, your tinnitus could already be 10 dB lower or you could be completely habituated to it.

As Dr. Shore has said, "the goal is to return to a state in which people can function well."

Let's try to put things in perspective.

Thank you for keepin' it real!

 

[Fightthearmy]

That's a completely normal use of the English language. Where are you from?

Believing my English on par with my native language (Swedish), the sentence is still not easy to grasp. The ways this could be parsed are as following:

A) The author thinks it'd be surprising if these things were no longer moving at a snail's pace, even now.

B) The author thinks the reason you shouldn't get too excited is because a decade is a very short time in medical R&D, even when there's no COVID-19.

C) The author wants you to consider that lots of other research has taken place over a decade.

 

[DeanD]

Believing my English on par with my native language (Swedish), the sentence is still not easy to grasp. The ways this could be parsed are as following:

A) The author thinks it'd be surprising if these things were no longer moving at a snail's pace, even now.

B) The author thinks the reason you shouldn't get too excited is because a decade is a very short time in medical R&D, even when there's no COVID-19.

C) The author wants you to consider that lots of other research has taken place over a decade.

As an Englishman the sentence articulates the point that this has taken Dr. Shore ten long years to get to the point we are now, and it hasn't even launched yet - which seems an incredibly long time for something like this to still not be available from the moment it was first discussed.

I got the poster's point, it made perfect sense and I agree with him.

It did make me chuckle reading your post above. My English is far from perfect but if you tried to explain what you just did to an average British person they would look at you as if you had gone quite mad.

Sidenote: It's very sad to read the posts from 2013 so full of hope.

 

[andrewdaniels]

Sidenote: It's very sad to read the posts from 2013 so full of hope.

I felt the same... Lots of hopium reading the posts from 2013... similar to now

 

[F-u-T]

Sidenote: It's very sad to read the posts from 2013 so full of hope.

It's disheartening knowing there is finally something that seems like it will help many of us sitting on a shelf collecting dust. I hope we don't have to endure this same conversation for the next two or who knows how many years before we are able to get some real world feedback on this device.

 

[dj_newark]

Believing my English on par with my native language (Swedish), the sentence is still not easy to grasp. The ways this could be parsed are as following:

A) The author thinks it'd be surprising if these things were no longer moving at a snail's pace, even now.

B) The author thinks the reason you shouldn't get too excited is because a decade is a very short time in medical R&D, even when there's no COVID-19.

C) The author wants you to consider that lots of other research has taken place over a decade.

If you came up with all those alternate interpretations of a simple, straightforward sentence, it's not. It's abundantly clear what he meant.

It's been a long 10 years since this thread was launched. I'm hoping for FDA approval this year and hopefully a few short years to commercialization. This thread is almost all speculation, but that is my hope.

 

[dj_newark]

Except relatively quiet, but very high frequency tinnitus may also be very difficult to mask but not necessarily considered loud. That is my case.

I don't really think that TFI/THI or MML are great ways of determining how someone is doing with their tinnitus. All you can really do is rely on someone's feedback to see how they are doing, due to the subjective nature of the disorder.

Masking to determine tinnitus volume is not an exact science by any stretch. There's so much variability there due to both human nature and the nature of the disorder itself. I have, however, been in medical trials for tinnitus where both were used.

There's lots of reasons why you may no be able to mask someone's tinnitus. As I've mentioned already, my tinnitus is not maskable. Until we have a more exact way of measuring tinnitus we are stuck with these imprecise methods. And practitioners/charlatans such as Dr. Ben Thompson will swear by them as if they are gospel!

I am waiting for an objective measure for tinnitus almost as much as I am waiting for Dr. Shore's treatment or XEN1101/BHV-7000.

 

[Jonno02]

June of 2013 was the first post on this thread about the device.

Thinking we'll be wearing this thing next year? I've got a bridge to sell you.

Need to be realistic and look at all options, and not hang our hat on just one.

Don't get me wrong, if it comes out tomorrow I'm signing up to try it. But it's been a decade. A decade.

A decade of development and studies.

We need to remember, this is a University venture. Not some multi-national medical device manufacturer that has a budget of £150M to funnel into this project alone. It's been a decade of researching the actual science behind tinnitus, animal studies and models, device development for humans and 2 clinical trials.

Just to put things into perspective. I regularly work with PhD students in the medical device field, and a PhD project is usually extremely narrow - nothing like developing a brand new technology like this. One of the recent ones I was involved with looked at blood platelet aggregation at various steps of chemotherapy/radiotherapy/immunotherapy. This took 4 years just to observe something and draw conclusions from it.

So 10 years to study the science behind this condition, locate the problematic area of the brain, prove your theories in animals, develop a device that should work on humans, prove your device works twice over and then get ready for regulatory submission is really quite good going for a University. Had this been a private company with many staff devoted to this 24/7 rather than having other job responsibilities outside of their research working at a University, we'd maybe be looking at those timelines halved, but then we've seen with Lenire that private companies have a vested interest to hit market whether it works or not.

Whether she's worked on this for 10 years or 20 years doesn't matter, the point is the same. None of us on this forum are as brilliant in the area of brain disorders/tinnitus as Dr. Shore's team. If we were, we'd be on it. This will be a bitter pill for some, but as much as great discussion takes place here, we just regurgitate what we've read in publications or say "I think this and that has something to do with tinnitus". Easy to say, difficult to prove and ever harder to develop a treatment for.

I'm not saying this device works as we hope, or that it'll cure everybody and I'm going to completely discount Lenire in this statement... because well... duh. On paper, this looks to be the first of its kind. A treatment for a condition that is so misunderstood and dismissed by so many in the medical profession - "just get used to it, it's just a noise." I'm not saying Auricle will have manufacturing contracts in place to hit the ground running when they get FDA approval or that their process for hitting market will be streamlined and we'll all be happy. If they get approval and a year later this device is still not out, sure, tear them a new one because that's the easiest part of the whole journey.

But I feel like we're going down a path here of saying that this device has taken so long to come out just because Dr. Shore and her team have purposely taken their time and it's just not really a good look, especially when she's just taken part in a Q&A for us all.

 

[Bhaveen]

Hi all.

I'm trying to take in all the information so apologies if this has been answered elsewhere.

I'm reading about a 10 dB reduction in tinnitus volume in the trial, which apparently is a 50% reduction in volume. Does that mean the participant would have a tinnitus loudness of 20 dB in the first place?

I'm just worried as from what I read 10 dB isn't actually that loud (equivalent to a quiet whisper) and if the participants only had 20 dB level of tinnitus in the first place, this again isn't a very loud tinnitus.

So are we saying the most we can hope for is the reduction in volume equivalent to a quiet whisper? Have I got something wrong here?

I appreciate any help. Thank you.

 

[annV]

I'm just worried as from what I read 10 dB isn't actually that loud (equivalent to a quiet whisper) and if the participants only had 20 dB level of tinnitus in the first place, this again isn't a very loud tinnitus.

So are we saying the most we can hope for is the reduction in volume equivalent to a quiet whisper? Have I got something wrong here?

No.

If you have 80 dB tinnitus and it reduces to 70 dB, that's 50% of reduction in perceived volume. That's how decibels work, it is logarithmic.

 

[andrewdaniels]

No.

If you have 80 dB tinnitus and it reduces to 70 dB, that's 50% of reduction in perceived volume. That's how decibels work, it is logarithmic.

I also recall Dr. Shore saying that 6 dB was roughly 50% of perceived volume (but I could be wrong).

 

[kingsfan]

Hi all.

I'm trying to take in all the information so apologies if this has been answered elsewhere.

I'm reading about a 10 dB reduction in tinnitus volume in the trial, which apparently is a 50% reduction in volume. Does that mean the participant would have a tinnitus loudness of 20 dB in the first place?

I'm just worried as from what I read 10 dB isn't actually that loud (equivalent to a quiet whisper) and if the participants only had 20 dB level of tinnitus in the first place, this again isn't a very loud tinnitus.

So are we saying the most we can hope for is the reduction in volume equivalent to a quiet whisper? Have I got something wrong here?

I appreciate any help. Thank you.

It means your tinnitus would be half as loud. 20 dB is twice as loud as 10 dB (the whisper you are referring to), but 50 dB is 8 times louder than 10 dB, I believe. So 50 dB reduced to 40 dB is going to feel like a significant decrease in volume.

 

[ploughna]

No.

If you have 80 dB tinnitus and it reduces to 70 dB, that's 50% of reduction in perceived volume. That's how decibels work, it is logarithmic.

Nice little test on this website that will demonstrate what 6 dB increments in volume sound like - scroll down the page and click on the log level test. Please be careful with your speaker/headset volume setting before clicking:

AudioCheck: The Non-Linearities of the Human Ear

 

[RunningMan]

I also recall Dr. Shore saying that 6 dB was roughly 50% of perceived volume (but I could be wrong).

Yes, that's in the Q&A somewhere, but I have read elsewhere, that tests have shown people may perceive somewhere from 6 dB to 10 dB to be twice as loud (increasing) or half as loud (decreasing). It also takes a greater change for dynamic sounds to be perceived twice as loud.

Also, in the trial, the active treatment resulted in about 5 to 6 dB reduction greater than the placebo.

There are some audio samples posted earlier in this thread showing some of these dB differences with tones.

 

[Alue]

Through masking levels. Yes, most tinnitus is subjective, but to determine volume they use MML - or Minimum Masking Level. They play a masking sound like a white noise through headphones and gradually increase the level until it covers the sound of your tinnitus. However, for some, like myself, tinnitus can be unmaskable. That's how they go about it in these medical trials and an audiologist who knows about tinnitus can also do this for you.

They did matching level when I went through clinical trials years ago. It's then matching level - sensory level to estimate the volume.

Some of my tones cannot be masked either.

 

[LGuapo]

Decibel isn't actually a unit of loudness at all, perceived or otherwise. Decibel is just a log scaling of a ratio, kind of like saying "twice as much", but logarithmic instead of linear.

In acoustics, the values being compared are often sound pressure levels. In this case, dB comparison = 20log(P1/P2), where log is the base-10 logarithm, and P1 and P2 are the two pressure levels that are being compared.

Notice that 20log(2) is roughly 6. This says that if one sound pressure measurement is twice as much as another, we say the first is 6 dB more than the other. Also notice that 20log(1/2) is roughly -6. So it's also true that a pressure level that is half as much as another is 6 dB less. This is why people sometimes say 6 dB is twice as loud (or quiet.)

This isn't really true though, since humans don't perceive loudness as a log scale of pressure difference like this. 6 dB is twice as much sound pressure, but not twice as perceived loud. To talk about perception of loudness, one needs a psychoacoustic metric, like the "sone" metric. For sound pressure levels (above 40 dBspl), a doubling of sones is roughly an increase in 10 dB. This is why people sometime say 10 dB increase is twice as loud. But it's even more complicated than this.

Why above 40 dBspl, you might ask. Well, human perception of comparative loudness varies depending on absolute pressure levels. (It also depends on frequency, and even time ordering in seemingly anti-causal ways!)

You may also ask, how can we even talk about a pressure level being above 40 dBspl if dB is a comparison of two pressures. Well, in fields where dB is a common comparison metric, is is also common to pick a conventional reference value. That is what dBspl is. So 40 dBspl is a sound pressure level that is 40 dB more than the agreed upon pressure reference level (which is 20 micropascals).

 

[JFR]

1. **General Understanding**: While decibels measure sound pressure levels in a logarithmic way, the general public often equates it with "loudness" for simplicity's sake.

2. **Versatility**: Decibels are used in many fields beyond acoustics because of their ability to describe ratios effectively.

3. **Practicality**: Even if decibels don't perfectly capture human perception of loudness, they're a globally recognized and practical standard for quantifying sound levels.

In essence, while decibels might not directly indicate perceived loudness, their widespread use and practicality make them an effective measure for most contexts.

 

[Bhaveen]

Does anyone with any FDA knowledge know if Neuromod announced it publicly when they submitted documents regarding Lenire for FDA approval?

Is it common practice for companies to publicly announce when they have submitted for FDA approval?

I just can't understand why Dr. Shore couldn't give us a yes or a no as to whether or not they have sought FDA approval...