New University of Michigan Tinnitus Discovery — Signal Timing

In my view, Dr. Shore, being science driven and not a businesswoman, will either launch something that works, or launch nothing. She has no obligations to investors like Neuromod, her primary goal and ambition is to be recognised as someone who improved quality of life of tinnitus patients, not the one who elevated revenues of Auricle.

 

That’s a good point. Precision appears to be the name of the game with the device and so it makes sense that they wouldn’t leave pitch matching and calibration up to the end user.

 

I question whether you would even be able to determine or match your pitch by yourself. I also wonder how pitch matching is done. Is it when you can't hear your tinnitus pitch? Because I can't hear a whole slew of frequencies.

 

@Survivor234 just joined and acts like they own the place.

 

@Survivor234, well, you need to be able to determine what your pitch is because, in the end, there is no way for another person to know it. And it really isn't that difficult to find the pitch, if the pitch is clear (for many people their tinnitus is a mess of pitches and broadband noises so it can get tricky or maybe impossible).

Also, there are a lot of musicians and sound creators/producers around here who design sounds themselves, so it would actually be easier if they let the end user make the sounds.

 

???

I'm just saying what others have said before and giving good reasons for why. I don't know how pointing out that it would be difficult to pitch match (something people have already stated they have difficulty doing) and asking questions about what pitch matching is means that I'm acting like I "own the place". I wouldn't even know what that would mean.

Is this really something that deserves an argument?

 

Buddy, the clinical trial is going on. When the device is approved and goes to market you can ask all these questions, but killing them with so many questions now while it is going through the clinical trial, for me, makes no sense.

Let them do the work and once it is ready for market, then we should know the answer to all the questions.

Bothering them with so many questions will only make them ignore you. I know we are all desperate for a cure or even something that helps us, but this is what it is and we need to wait.

 

I'm not asking the researchers questions though, I'm asking people here questions. I was asking people here about how pitch matching is supposed to work, especially considering that people here have difficulty with doing it. Like, take into consideration the actual post you're responding to. Where in the post you're quoting did I mention the researchers or say I would ask them anything?

And the guy I was responding said I was acting like I "own the place". Just because I asked people here a question about pitch matching and responded to someone who was talking to me. I have no idea why they were so aggressive or what their deal is.

 

Given Auricle has been around for 2+ years they're certainly already working on getting audiology training and distribution in place. If the device becomes FDA approved, you better believe Auricle will be quick to monetize. They're not sitting on their hands waiting to see if it gets approved or not before building the business.

 

Hard Agree. This is why academics, researchers, companies, CEOs, etc, setup Q&A events or interviews with people like those running the TinnitusTalk Podcast. They are establishing an appropriate forum for potential patients / customers / doctors / investors, etc to ask questions and get qualified answers. Let's show them some respect and not blast them via email, tweet at them, or utilize any other pedestrian means to bother them. The field they're working in (hearing loss / tinnitus / hyperacusis) is already EXTREMELY underfunded and under-researched given its prevalence (MILLIONS) and duration (since recorded history of mankind), let's not scare away or disenfranchise the small cohort of people who can actually move science / commercialization towards a useable treatment.

 

All I hope is that the global distribution is faster than Lenire. After 2 years Lenire still is not available in the US.

For us in Europe, I hope this does not mean the device reaches us in 2024. I hope some big pharma is interested in licensing/buying Auricle. They have worldwide network, hospital network etc. A startup cannot do this on their own fast enough.

 

Unfortunately, this device may not work for those who have moderate or worse hearing loss at the tinnitus frequency, and for those who won't be able to find their frequency, especially if you have several tones, or hissing sounds.

 

@InNeedOfHelp, I believe the reason why Lenire isn't well distributed, even in Europe, is that it doesn't work. Clinicians see that patients are not satisfied.

My ENT told me that if something works (I'm hopeful that the Shore device will), then there will be much greater distribution and everyone will run to get it. He told me that if it works, it will come fast even to my country (Greece) which is a lot more underdeveloped than rest of Europe etc.

 

Just looking at the ClinicalTrials site and noticed some differences in the current study vs the old one. Aside from the much higher participant numbers (400 vs 20), this round is testing 6 weeks of treatment vs 4 weeks previously and is testing both 30 and 60 minutes treatments vs just 30 minutes previously.

84 days till April.

 

What is the definition of well-distributed? Lenire is available in about 100 clinics in England, Belgium, Germany, Switzerland, Austria, and Ireland. If the product wasn't successful at all we wouldn't see it in that many clinics.

Plus there was COVID-19 in the last 2 years. A lot of people still don't understand that the technology behind Lenire is the same that is behind UMich device. It is just applied differently. There is some efficacy, maybe UMich has more.

 

Can't come soon enough!

 

Technology is TOTALLY different. Lenire targets no DCN or Fusiform cells. It is just a habituation device. It is a marketing scam basically. Theranos Mark II.

 

Just goes to show how much demand there is for a treatment, even one that is at best modestly better than placebo, and how quickly the existing audiological infrastructure can accommodate the distribution of a product when it becomes available. Imagine how fast audiologist offices will line up to sell a device that is actually effective. Imagine how great it would feel as a medical professional to finally be able to decrease people's suffering while raking in the bucks.

...or maybe it will just be another Lenire

 

April is primary completion date. Analysing data, report etc will take some months...!

Unless they would unblind earlier but I'm afraid that is not the case.

 

I don't think that is the case. Primarily they would like frequency matching, but keep in mind that you don't know the frequency of tinnitus in guinea pigs either. They just went with 8 kHz because this is the most common tone. They don't know if guinea pigs have one sound, multiple sounds, hissing, etc. It might take some trial and error once the device is released. There was no trial inclusion criteria for pure tone tinnitus either.

 

We'll see. I read that they won't be unblinding till the end of the study, but hopefully it won't be too long to get the headline data thereafter. I would imagine the data is sitting there clean as can be waiting for the unblinding to attach the one last attribute to the data lines.

From previous statements both from Shore and Auricle it sounds like the intent is to present to FDA and get to market as fast as possible (assuming the results are what we hope), so I don't think this is the case where an academic will take months to process data waiting to present new data at some conference.

 

Isn’t she a speaker at the Tinnitus Research Initiative in Vancouver at the end of June?

She could end up making a big splash there with some positive results...

 

Can she speed things up?

Asking for a friend.

 

I would imagine those of us who have a barrage of different tones will need to start with the easiest one to match and try to remove/reduce them one-by-one... pulling the curtain back on each one so to speak.

 

Maybe it can address multiple neighbouring frequencies simultaneously...

 

Hi all,

Just got confirmation from Jon Pearson that the device will most likely be prescriptive due to the pitch matching assessment so we will see this distributed in a clinical setting if it makes it to market.

I respect everyone’s opinions and thoughts whether you are for or against contacting business and research members about the project. I’m in a highly distressed state with the recent onset of chronic reactive HF tinnitus so I am beyond being concerned about the opinions of others at the moment. Hope this provides some answers and comfort to anyone who is seeking them.

Much respect to @Survivor234 for the insight you have been able to gain and share while remaining respectful and humble in response to all the criticism that has been sent your way. The lack of compassion from some of the responders has been downright disheartening.

Minor tidbit - I like the branding and marketing as far as the logo goes.

 

How do they know it worked on guinea pigs? Let me guess, the guinea pigs were more happy in life.

 

Tbh, if Dr. Shore's device works in either eliminating or strongly reducing tinnitus (not a shitty improvement you can account for placebo), I don't care waiting another year or maybe two as long as we have something to get out this hell...

 

Hopefully they have a better loudness test than just pumping sound through headphones until it's as objectively loud as your tinnitus. Some may leave the exam with louder tinnitus.

 

Good to know - thanks for the efforts. I hope this speeds things up by not having to build a distributor/retail network but becoming a standard treatment for tinnitus which can be initiated by an ENT. Downside for us in Europe that EMA approval might be required which is not spoken of as of yet...

At least with the 400 people trial we get to know the subgroups that will likely benefit. Phase 1 had 12/20 patients (60%) benefitting.

Let's hope medical devices are fastlaned in chip production land. The global shortage is not in our favor either.