New University of Michigan Tinnitus Discovery — Signal Timing

[AfroSnowman]

Remember, for what it is worth, that this was first trialed successfully in guinea pigs. There was no checking whether they could modulate their tinnitus or tone matching and it worked. So at least a little hope is warranted.

 

[Joshyboy]

I don't think the results will be as spectacular as the trial results, they rarely are

Any guess for success rates? I'm thinking on average 10%-50% reduction of tinnitus in 60% of people.

 

[SarahMLFlemmer]

I like the sound of that timeline. I wonder what makes you think approval will take place in July 2024?

I believe the same!

Best case scenario: if the FDA submission is put in the first quarter of 2024 (latest being March), and it only takes 90 days to approve, the latest we should see it out should be in July!

I do wonder how long it will take to train the doctors that will be making it available for us.

I'm hopeful, nonetheless, to see it by mid next year!

 

[Joeseph Stope]

I believe the same!

Best case scenario: if the FDA submission is put in the first quarter of 2024 (latest being March), and it only takes 90 days to approve, the latest we should see it out should be in July!

I do wonder how long it will take to train the doctors that will be making it available for us.

I'm hopeful, nonetheless, to see it by mid next year!

I'm packing my bags. Where's my tent? Does the weather get awful hot or cold in Michigan?

 

[RunningMan]

Any guess for success rates? I'm thinking on average 10%-50% reduction of tinnitus in 60% of people.

10% would so little. 6 dB would be 50%, and the average reduction was greater than that in the trial.

53% of the entire group of 99 receiving active treatment had clinically significant improvement in their tinnitus scores compared with 20% in the control (placebo) group, so that's 33% points better for those receiving the active treatment. Weed out those who got worse and dropped out or didn't follow the protocol, and the results look a little better for those who remained, so the PP group had 60% having clinically significant improvement with the active treatment vs. 25% control (placebo). So, that's 40% points better with the active treatment.

Real world results, which I expect will include some people who couldn't have qualified for the study, will probably have lower results. But, hopefully we will see close to 50% or more with a perceived improvement when combined with the placebo effect. I'm willing to give it a shot.

 

[Nick47]

Any guess for success rates? I'm thinking on average 10%-50% reduction of tinnitus in 60% of people.

Realistically, I think 10% will get a big benefit, 30% decent benefit and 10% a little benefit, the rest no benefit.

 

[MiaVIL]

Why are we so pessimistic that it will only help 60% of people? Dr. Shore is putting up a lot of money for this and isn't she focusing all her attention now on Auricle?

 

[SarahMLFlemmer]

I'm packing my bags. Where's my tent? Does the weather get awful hot or cold in Michigan?

I'm in Cali, so I'm not too sure! I think it gets pretty cold in that area.

 

[ajc]

Why are we so pessimistic that it will only help 60% of people? Dr. Shore is putting up a lot of money for this and isn't she focusing all her attention now on Auricle?

Thinking it might help 60% of people is far from pessimistic.

There are very few treatments out there for any condition that help 100% of people or anywhere close to it.

If the device helps 60% of tinnitus sufferers, it's a fucking amazing achievement. It probably won't help 60% to a great deal, but maybe a little bit...

 

[Nick47]

Why are we so pessimistic that it will only help 60% of people? Dr. Shore is putting up a lot of money for this and isn't she focusing all her attention now on Auricle?

Nothing pessimistic at all. The trial results showed 60% but placebo 20%.

 

[R0B]

"Regulatory Pathway: Presubmission to FDA complete with feedback for path forward for DeNovo device"

I keep seeing references to 510(k) approval process but the last time I looked, De Novo was mentioned on the Michigan Univesity website. I looked at the site again but they changed things around and I can't find it anymore. Maybe they won't go with De Novo after all but when I looked last time it was mentioned.

 

[WillBeNimble]

I would say the really good thing is if the device does help people, an infrastructure will be built around it. You'll stop being told "Oh, there's nothing we can do." If you have mild to moderate tinnitus, you'll be recommended the device. As part of it, extended audiograms will become more commonplace, which they always should have been. This in turn will hopefully push us to a more hearing conscious society and doctors, with less people being hurt and more dangers identified. This is all good.

It does make me worried that there will be less investment after though. HOWEVER, there will always be wars and combat wounds that will ruin hearing all at once, so yeah, there's still a reason to do the research.

 

[Jim Vasilakis]

As part of it, extended audiograms will become more commonplace, which they always should have been.

Extended audiograms aren't going to be very useful since everyone has damage to the higher frequencies due to age. A person in his 30s who doesn't hear 17000 Hz, there is no way to know if it's due to age or noise damage.

 

[Joshyboy]

I don't think they changed timing, but instead the intensity of the pulses:

It really is fascinating how Susan and her team have perfected the exact tone/pulse needed to calm the auditory nerve. Many have tried before... Neosensory Duo, Lenire, magnetic pulses, TENS and haven't gotten the results promised. It feels like such a simple stimulation process, yet she seems to have gotten the timing, sound and location placements better than anyone before her.

 

[SarahMLFlemmer]

Extended audiograms aren't going to be very useful since everyone has damage to the higher frequencies due to age. A person in his 30s who doesn't hear 17000 Hz, there is no way to know if it's due to age or noise damage.

I agree. I am 36 and my audiogram shows hearing loss at 16 kHz. I think it's either from natural aging or possibly it is the Hz my tinnitus is already at and that's why I can't hear it, because my tinnitus kinda cancels it out. Just my speculation so IDK.

 

[chinup]

My residual inhibition works at any tone frequency. My 9.5 kHz tinnitus disappears even if I play a 400 Hz tone. I don't think there will be a definitive answer to this question until individuals get their hands on the device.

That's interesting. I have to match the tones to within a few Hz. Unfortunately I have over a dozen tones, so while I'm inhibiting lower frequencies the higher ones come back and vice versa... eventually I'll make an audio file with all of the tones and enjoy sweet sweet silence for a few seconds.

I agree that ultimately it's anyone's guess as to how the device will work.

10% would so little. 6 dB would be 50%, and the average reduction was greater than that in the trial.

53% of the entire group of 99 receiving active treatment had clinically significant improvement in their tinnitus scores compared with 20% in the control (placebo) group, so that's 33% points better for those receiving the active treatment. Weed out those who got worse and dropped out or didn't follow the protocol, and the results look a little better for those who remained, so the PP group had 60% having clinically significant improvement with the active treatment vs. 25% control (placebo). So, that's 40% points better with the active treatment.

Real world results, which I expect will include some people who couldn't have qualified for the study, will probably have lower results. But, hopefully we will see close to 50% or more with a perceived improvement when combined with the placebo effect. I'm willing to give it a shot.

The elephant in the room is that no one knows what happens with genuine long term use of the device. Can you completely nuke your tinnitus if you zap your ears daily for a year straight? That's one of the biggest questions for me.

 

[Jonno02]

It really is fascinating how Susan and her team have perfected the exact tone/pulse needed to calm the auditory nerve. Many have tried before... Neosensory Duo, Lenire, magnetic pulses, TENS and haven't gotten the results promised. It feels like such a simple stimulation process, yet she seems to have gotten the timing, sound and location placements better than anyone before her.

I think it's because she's a scientist at heart and this is essentially her life's work. She's in charge and has taken her time to get things as good as they possibly can be.

Other ventures are likely a 'invest and we'll deliver something in 'X' years' so they just launch whatever nonsense they've come up with in that time.

 

[Jim Vasilakis]

I agree. I am 36 and my audiogram shows hearing loss at 16 kHz. I think it's either from natural aging or possibly it is the Hz my tinnitus is already at and that's why I can't hear it, because my tinnitus kinda cancels it out. Just my speculation so IDK.

Only a 24-year-old can hear 17000 Hz so I think it's natural. There is a reason ENTs don't do extended audiograms. Unless you are a kid, every adult is going to have some loss in those frequencies.

 

[WillBeNimble]

Extended audiograms aren't going to be very useful since everyone has damage to the higher frequencies due to age. A person in his 30s who doesn't hear 17000 Hz, there is no way to know if it's due to age or noise damage.

But what if that same person can't hear 14 kHz? Should we not test to catch that?

Also, there's a general curve we can find for when people lose that hearing if we collect the data. This would make the above statement false, because we'd have a general idea of where you should be more accurately to the current times and if one is taking care of their ears.

This idea of age-related hearing loss was made because of a flawed extrapolation of data from Guinee pigs to humans. Hearing is powered by an inner ear battery that we thought would run out of juice eventually because it does for Guinee pigs, leading to the upper bands dying off. This just isn't the case, as shown by this study. It is largely our exposure to loud noises. There's plenty of people that can hear WELL above their ages hearing bands due to taking care of their hearing, and unfortunately, many that hear well below. Now, should we blast high frequency noise louder than 30-40 dB to try and find the edge of the hearing band, no, but we should at least establish what that edge is.

I agree. I am 36 and my audiogram shows hearing loss at 16 kHz. I think it's either from natural aging or possibly it is the Hz my tinnitus is already at and that's why I can't hear it, because my tinnitus kinda cancels it out. Just my speculation so IDK.

If you can hear above it, I would venture a guess it might be your tone. If you're tone searching, I would caution you on some of the online tone generators, as they can be set rather loud to start. If you can't hear it, I would say listen to one octave lower, so 8 kHz, to see if it sounds similar. If it does, well, it might be your tone that you can't hear anymore. Then again, maybe a warble would help, as that helps distinguish from tinnitus. However, it doesn't mean that extended audiograms wouldn't give the medical field more insight on what causes tinnitus, nor sufferers, especially for the more mild cases, who more than likely can still hear their tone, and at that point, pinpoint what dB level of loss they have, so it can be monitored and prevented from getting worse. With Dr. Shore's device though, it will swap to treatment, rather than monitoring. Undoubtedly, with release of the device, research-minded ENTs will get a treasure trove of data to sort through. Lucky them.

Also, it sounds like you got your extended audiogram to find that loss. Which does tell you more about the state of your hearing then a normal audiogram, and if everywhere else is fine, points to it being your tone if you can't match it with a tone generator anywhere else, because let's be real, there's 17ish kHz to go through, and it could be any one, as we don't have a previous extended audiogram from before you got tinnitus to compare against. If you had one from like 5 years ago and it showed that you had better hearing up to 17 kHz, then perhaps it is the 16 kHz.

 

[SilverFox]

Only a 24-year-old can hear 17000 Hz so I think it's natural. There is a reason ENTs don't do extended audiograms.

This is not necessarily true. I heard 20 kHz into late twenties and can hear 18 kHz now in mid-thirties. There are many people like this; age-related hearing loss is individual.

I found extended audiograms very useful because they actually show the whole picture, unlike a standard audiogram which leaves you guessing after 8 kHz. Yes, frequencies above 8 kHz are not useful in everyday life, but full testing is useful for clinical diagnostics.

 

[SarahMLFlemmer]

But what if that same person can't hear 14 kHz? Should we not test to catch that?

Also, there's a general curve we can find for when people lose that hearing if we collect the data. This would make the above statement false, because we'd have a general idea of where you should be more accurately to the current times and if one is taking care of their ears.

This idea of age-related hearing loss was made because of a flawed extrapolation of data from Guinee pigs to humans. Hearing is powered by an inner ear battery that we thought would run out of juice eventually because it does for Guinee pigs, leading to the upper bands dying off. This just isn't the case, as shown by this study. It is largely our exposure to loud noises. There's plenty of people that can hear WELL above their ages hearing bands due to taking care of their hearing, and unfortunately, many that hear well below. Now, should we blast high frequency noise louder than 30-40 dB to try and find the edge of the hearing band, no, but we should at least establish what that edge is.

If you can hear above it, I would venture a guess it might be your tone. If you're tone searching, I would caution you on some of the online tone generators, as they can be set rather loud to start. If you can't hear it, I would say listen to one octave lower, so 8 kHz, to see if it sounds similar. If it does, well, it might be your tone that you can't hear anymore. Then again, maybe a warble would help, as that helps distinguish from tinnitus. However, it doesn't mean that extended audiograms wouldn't give the medical field more insight on what causes tinnitus, nor sufferers, especially for the more mild cases, who more than likely can still hear their tone, and at that point, pinpoint what dB level of loss they have, so it can be monitored and prevented from getting worse. With Dr. Shore's device though, it will swap to treatment, rather than monitoring. Undoubtedly, with release of the device, research-minded ENTs will get a treasure trove of data to sort through. Lucky them.

Also, it sounds like you got your extended audiogram to find that loss. Which does tell you more about the state of your hearing then a normal audiogram, and if everywhere else is fine, points to it being your tone if you can't match it with a tone generator anywhere else, because let's be real, there's 17ish kHz to go through, and it could be any one, as we don't have a previous extended audiogram from before you got tinnitus to compare against. If you had one from like 5 years ago and it showed that you had better hearing up to 17 kHz, then perhaps it is the 16 kHz.

Would hearing loss affect hair cells or not? My audiologist checked all that and the pressure and my hair cells were okay.

 

[AfroSnowman]

I found extended audiograms very useful..,

For me useless. Same tinnitus and same problems hearing as if I didn't get an extended audiogram. Information that I can take no action with is just a curiosity.

 

[RunningMan]

This is not necessarily true. I heard 20 kHz into late twenties and can hear 18 kHz now in mid-thirties. There are many people like this; age-related hearing loss is individual.

Same here. I often tweaked the 16 kHz band on my equalizer and noted the change easily. Now, I can't hear a change.

Residual inhibition doesn't seem to work for me unless I get somewhat close to the tinnitus frequency with the external tone. I have tinnitus tones in low, mid, and high frequencies. I can't even knock those high tones out completely. But after I stop the external tones, the residual inhibition ends and tinnitus returns to baseline over 15 to 30 seconds.

 

[MrChips13]

My audiologist checked all that and the pressure and my hair cells were okay.

How did the audiologist check for that? I had an entire brain MRI of the auditory cortex and was told that it was not detailed enough to detect hair cell damage. At least, that's what I was told. I'm not a doctor.

 

[WillBeNimble]

Would hearing loss affect hair cells or not? My audiologist checked all that and the pressure and my hair cells were okay.

Hearing loss can come from several places. The loss of the hair cells, the loss of connection between the nerves and the hair cell, as well as the loss of the nerve cells. Currently, there is no way to look at any of those directly except post mortem methods. So, we use audiograms to give us an idea of what frequency ranges we can hear.

So, in short, maybe, and I would even go so far as to say most likely. Now, as for why you have tinnitus, that's another question. Could be damage to the nerves, destroyed gates, so on and so forth.

 

[SarahMLFlemmer]

How did the audiologist check for that? I had an entire brain MRI of the auditory cortex and was told that it was not detailed enough to detect hair cell damage. At least, that's what I was told. I'm not a doctor.

The audiologist put some kind of headphones into my ears and somehow watched how my ears responded to the sounds. It's called an OAE test.

 

[slc]

The audiologist put some kind of headphones into my ears and somehow watched how my ears responded to the sounds. It's called an OAE test.

I just looked up the OAE (otoacoustic emissions) test which...

is used to find out how well your inner ear, or cochlea, works. It measures otoacoustic emissions, or OAEs. These are sounds given off by the inner ear when responding to a sound. There are hair cells in the inner ear that respond to sound by vibrating. The vibration produces a very quiet sound that echoes back into the middle ear. This sound is the OAE that is measured.

If you have normal hearing, you will produce OAEs. If your hearing loss is greater than 25–30 decibels (dB), you will not produce these very soft sounds.

(Source: American Speech Language Hearing Association).

I wonder if the OAE test might enable practitioners using Auricle to assess frequencies and to determine the level of response in the cochlea.

 

[AfroSnowman]

As we are now getting close to 2024 and knowing that this is supposed to be submitted to FDA in the first quarter, is there anyplace on the FDA website that lists when devices are under review?

 

[ccm302]

As we are now getting close to 2024 and knowing that this is supposed to be submitted to FDA in the first quarter, is there anyplace on the FDA website that lists when devices are under review?

I'm not sure if this is the correct place to look, but...

• 510(k)
• Premarket Approval
• De Novo

I guess the trick would be searching for the correct thing in the correct field.

 

[dd314]

The more I read about Dr. Shore's device, the more my intuition is telling me it won't help with low-frequency droning, humming and rumbling type sounds, like those common of endolymphatic hydrops. Hope I'm wrong!