New University of Michigan Tinnitus Discovery — Signal Timing

[Utdmad89]

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!

From what?

 

[Anuar Lukios]

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!

Why do you think it shouldn't work for low-frequency tones?

 

[SarahMLFlemmer]

You won't need to stay in America for 12 weeks. You'll buy the device and take it home and use it. That's it!

Do you still think we'll be able to take the device home or do you think we'll have to visit and get it done?

 

[dj_newark]

Do you still think we'll be able to take the device home or do you think we'll have to visit and get it done?

You'll have to visit a clinic to set the device, but I think it's designed for home use.

 

[Muggumbo]

Do you still think we'll be able to take the device home or do you think we'll have to visit and get it done?

Pretty sure it's all going to be done at home since the study was done at home. The only thing an audiologist needs to do is adjust the tone.

 

[Dkellz]

There's something seriously comforting to me that someone reading this thread daily, with bothersome tinnitus, is going to get relief from this device.

It won't be us all, but there's someone out there who is at the end of the road this device will save. There's something amazing about that and the day we can read this experience on this thread will be absolutely amazing.

 

[Pixelito]

There's something seriously comforting to me that someone reading this thread daily, with bothersome tinnitus, is going to get relief from this device.

It won't be us all, but there's someone out there who is at the end of the road this device will save. There's something amazing about that and the day we can read this experience on this thread will be absolutely amazing.

I think that Dr. Shore's device will save many. A 65% success rate is pretty much the beginning of the end of tinnitus as we know it.

 

[R0B]

There are several concerning reviews of Lenire on Tinnitus Talk of it making tinnitus worse for people. I'm surprised that these sort of results did not show up in the trial results. It also makes me concerned about any other treatments like the Michigan Tinnitus Device that's coming out and what the reviews will be like even though the trial results look good. Any thoughts if it will be a different story in this case?

 

[Jonno02]

There are several concerning reviews of Lenire on Tinnitus Talk of it making tinnitus worse for people. I'm surprised that these sort of results did not show up in the trial results. It also makes me concerned about any other treatments like the Michigan Tinnitus Device that's coming out and what the reviews will be like even though the trial results look good. Any thoughts if it will be a different story in this case?

Because Lenire 'trials' were a total sham.

 

[Anuar Lukios]

There are several concerning reviews of Lenire on Tinnitus Talk of it making tinnitus worse for people. I'm surprised that these sort of results did not show up in the trial results. It also makes me concerned about any other treatments like the Michigan Tinnitus Device that's coming out and what the reviews will be like even though the trial results look good. Any thoughts if it will be a different story in this case?

If you read the Q&A by Susan Shore, she specifies that there were no side effects (except a little discomfort from the electrodes at the beginning, until you get used to it) and that the worsening present in the graph was due to exposure to loud noises (such as concerts) during treatment.

 

[Muggumbo]

One thing that I'm excited to see is how people will use the device outside of a trial setting. Technically you could let the thing run all day if you want. There might be a better effect when using it longer than the 30 minutes the people in the trial did.

 

[slc]

One thing that I'm excited to see is how people will use the device outside of a trial setting. Technically you could let the thing run all day if you want. There might be a better effect when using it longer than the 30 minutes the people in the trial did.

Hopefully we'll be able to get data from real world treatment. I would hesitate to use it all day until I learned more, lol! But your point is well taken. It would be a very useful follow-up study to assess different lengths of time for treatment, both in terms of daily dose and number of weeks used.

 

[Tomas80]

Do you think Dr. Shore's device will be personalized? Any special setting for each person? For example, according to hearing loss, or tinnitus frequency? I'm asking if it would be possible for someone from Europe to secure 2 devices and sell one to me when visiting the USA. Auricle would lose nothing, not even a dollar, but I would save on an expensive trip...

 

[slc]

Do you think Dr. Shore's device will be personalized? Any special setting for each person? For example, according to hearing loss, or tinnitus frequency? I'm asking if it would be possible for someone from Europe to secure 2 devices and sell one to me when visiting the USA. Auricle would lose nothing, not even a dollar, but I would save on an expensive trip...

I am guessing that Auricle will train audiologists to adapt the device to individual users. It seems that setting the frequency, or band of frequencies, will be needed. It would be great if that could be done remotely during an online appointment.

I wonder how they will address us folks whose tinnitus varies in frequency as well as those with multiple frequencies. I believe some of these questions came up in the Q&A with Dr. Shore as well as within this thread.

 

[Muggumbo]

Do you think Dr. Shore's device will be personalized? Any special setting for each person? For example, according to hearing loss, or tinnitus frequency? I'm asking if it would be possible for someone from Europe to secure 2 devices and sell one to me when visiting the USA. Auricle would lose nothing, not even a dollar, but I would save on an expensive trip...

It has to be set by an audiologist with access to the software they use. It needs to be adjusted to the frequency of your tinnitus.

 

[SarahMLFlemmer]

It has to be set by an audiologist with access to the software they use. It needs to be adjusted to the frequency of your tinnitus.

I don't even understand how we would find that frequency.

 

[AfroSnowman]

I don't even understand how we would find that frequency.

Pick a dominant tone among the many.

 

[SarahMLFlemmer]

Pick a dominant tone among the many.

I think my tone is the frequency that I "stop hearing at." So 16 kHz is enough to "drown out" my tinnitus, so I think that would be the tone. Not sure.

 

[Nick47]

My tinnitus is just a screeching, grinding, broad white noise. I've never sat there and counted the number of tones.

My hearing loss is at 4000 Hz, 6000 Hz, and 8000 Hz. They don't do extended audiograms in the UK, and being in my late 40s I'm bound to have hearing loss at all frequencies beyond 8000 Hz. I like music and sports and I have lived!

I read that 64% of tinnitus occurs between 3000-10000 Hz, with the most common tinnitus frequency being 8037 Hz. So that is a good place to start, along with your own audiogram.

 

[Jim Vasilakis]

I don't think it needs to be the exact tinnitus frequencies, just approximating.

 

[RunningMan]

Regarding matching the tone, this was covered in the Q&A, so no need to speculate:

Do you need to be able to match your tinnitus tone to use the device? What if you don't have a stable tinnitus tone, but e.g., electrical noises, crickets, screeching, or multiple tinnitus tones in various frequencies? Can all these different tones and/or sounds be treated at the same time? Does the treatment work better for a certain kind of tinnitus, such as tonal high frequency?

The TinnTester interactive tinnitus matching software program is designed to match different kinds of tinnitus and has shown high test-retest reliability. Most tinnitus is narrow band or wide band, meaning it is comprised of multiple frequencies – called the tinnitus spectrum. We matched the tinnitus spectrum and presented this as the sound part of the bisensory stimulus. We did not see differences based on spectrum.

 

[kingsfan]

Can we just do every frequency? I like to be thorough.

 

[Pixelito]

Assuming it will actually submitted to the FDA in Q1, can we guess it'll be about two years before the device will be available?

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!

The FDA goal for a priority review is 6 months. The standard review is 10 months.

90 days? That would be awesome, but I'm not sure where that's coming from. Also, judging by the glacial rate that which Dr. Shore has accomplished everything, a Q1 submission is far from certain.

 

[dj_newark]

Assuming it will actually submitted to the FDA in Q1, can we guess it'll be about two years before the device will be available?

The FDA goal for a priority review is 6 months. The standard review is 10 months.

90 days? That would be awesome, but I'm not sure where that's coming from. Also, judging by the glacial rate that which Dr. Shore has accomplished everything, a Q1 submission is far from certain.

Not sure where that's coming from? It comes from the FDA itself!

The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request.

In this context an AI request would mean an 'additional info request' or in other words the FDA is asking questions of the requestors. This is a normal part of the process and not an indication that anything is wrong. AI requests stop the clock on the FDA approval process, but it should still only be a little more than a few months for the case to be decided.

It may seem that she's moving at a glacial pace, but Dr. Shore has stated she wants to move quickly through the FDA approval process and commercialization. I've found out that the bulk of the work for FDA approval is preparing the documentation to send to the FDA. That alone can take anywhere from 6 months to 2 years or even more!

 

[Fields]

As per the FDA's ruling on Lenire, we know the following:

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Lenire, and substantially equivalent devices of this generic type, into Class II under the generic name combined acoustic and electrical external stimulation device for the relief of tinnitus.

It is then hypothesized that Auricle can take a shortcut by submitting their device as a 510(k) (as an electrical external stimulation device for the relief of tinnitus):

Auricle is similar enough to the Lenire device (although Auricle actually works) that it can be submitted as a 510 (k) submission. FDA rules require a decision within 90 days of submission.

 

[Eric N]

Will Dr. Shore's device prevent tinnitus from getting worse and stop spikes from happening? Or are we destined to wear hearing protection forever?

 

[dj_newark]

We have an update from Auricle CEO Jon Pearson:

Thank you for your kind and considerate message. Speaking on behalf of the founding team, we are greatly appreciative and thankful for your note. We are indeed dedicated and focused on bringing The Shore Lab's tinnitus therapy to market, and thereby being able to provide potential relief to the millions of global tinnitus sufferers.

We are indeed aware of the various online tinnitus communities and other tinnitus-related message boards. It has been impressive and instructive to see both the degree and depth of interest and discussion concerning tinnitus, and it is clearly indicative of the great unmet need for therapeutic relief. As a way of enhancing information about Susan Shore's treatment approach, she was glad to have participated in an interview on Tinnitus Hub. While we could not provide answers to questions pertaining to the regulatory clearance and commercialization questions, we tried to provide additional information that would be clarifying (if not also helpful).

With regard to investment, Auricle is privately held and its capital needs are met. We have several tinnitus sufferers among our investors, so we know that interest in a therapy is significant, real, and deeply personal. Thank you for your offer to provide any kind of support that the company may need, but at present we are focused on and identifiable number of tasks and we have the right resources.

Best wishes to you in 2024.

Kind regards,
Jon

I found this email every encouraging and reassuring!

 

[Joey Lodes]

Will Dr. Shore's device prevent tinnitus from getting worse and stop spikes from happening? Or are we destined to wear hearing protection forever?

The Shore device is designed to treat / lower tinnitus, not mitigate or restore hearing loss. So I would guess hearing protection is still an absolute necessity. Hopefully other researchers can crack THAT code in our lifetime, but the Dr. Susan Shore device is a major step in the right direction.

 

[Pixelito]

The Shore device is designed to treat / lower tinnitus, not mitigate or restore hearing loss. So I would guess hearing protection is still an absolute necessity. Hopefully other researchers can crack THAT code in our lifetime, but the Dr. Susan Shore device is a major step in the right direction.

I guess that was confirmed by one test subject who decided to attend a rock concert during the testing period.

 

[Fields]

I guess that was confirmed by one test subject who decided to attend a rock concert during the testing period.

It will be interesting to see how effective the Auricle device will prove to be when it comes to successive/renewed tinnitus due to various causes.

Would be a relief to know you can fall back on the Auricle device after an unfortunate acoustic trauma, for example.

But surely, after some time, there comes a point you'll get diminishing returns?