New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

Nice job @Markku and @Hazel! I really appreciate the hard work. When she says "The company is certainly working on a regulatory clearance" I hope that means is that they've submitted to the FDA!

 

[Brian Newman]

Dr. Shore really didn't care about hyperacusis and noxacusis, did she lol.

 

[2noist]

 

[llecrup]

10. Current or former use of any of the following medications within the past 6 months: high dose aspirin (>325mg/day), high dose NSAIDs (ibuprofen, Motrin, Celebrex) (>800mg/day), narcotics (any opioids), lithium, clonazepam, oxazepam, cholinergic medications (anti-dementia medications), anti-depressant medications (serotonin specific reuptake inhibitors; SSRIs, tri-cyclic anti-depressants; TCAs); anti-seizure/convulsant medications (Depakote), anti-psychotic medications (Haldol, Seroquel), Ototoxic medications, other chemotherapy agents, benzodiazepines, and central nervous system stimulants

I guess I will have to give up sleep for 6 months if I want to try this device.

 

[RunningMan]

I guess I will have to give up sleep for 6 months if I want to try this device.

Looks like those lists are regarding the inclusion and exclusion criteria that were used for participating in the study rather than a patient using the device for treatment after it's approved commercially. For example, one of the items listed is "9. Resides within 100 miles of the study site." It makes sense that they would be more selective for the study participants.

 

[Markku]

everyone for the kind words.

I know there are open questions that we didn't get the answers for, but we just have to accept the fact that, at the end of the day, it is a business they are running, in a very regulated sector, and it is understandable if they think it's better to be safe than sorry.

We don't stop here though, any opportunity we get, we'll keep updating the community on her work and Auricle. You can expect more in future.

Looks like those lists are regarding the inclusion and exclusion criteria that were used for participating in the study rather than a patient using the device for treatment after it's approved commercially. For example, one of the items listed is "9. Resides within 100 miles of the study site." It makes sense that they would be more selective for the study participants.

Yes, this answer will likely get amended soon.

 

[Boone]

When she says "The company is certainly working on a regulatory clearance" I hope that means is that they've submitted to the FDA!

Go and take a look for yourself. You can search the FDA's public 501k premarket database. I couldn't find anything related to Auricle, but perhaps someone with more know-how and more time could find something.

FDA: 510(k) Premarket Notification

 

[Ngo13]

Based upon her answer about compassionate use and not being able to support it due to Auricle's lack of infrastructure, I don't believe Auricle is at all close to market ready. I think it will take some time after FDA approval before they are able to distribute. It's understandable, since I'm sure no one wants to financially back a company who doesn't have an approved device (yet).

Bad news for us though, I think we will be waiting a lot longer than anticipated. But it will be worth the wait I'm sure!

 

[SarahMLFlemmer]

Interesting to hear that Dr. Shore has tinnitus herself, although she said hers was mild. It's crazy that she wouldn't want to try her own device. She did state that was because of conflict of interest, which I get, but oh man, that would be so hard for me!

 

[InNeedOfHelp]

Thank you for summarizing @Markku. Nicely formatted too.The only answer that for me was really helpful is the following:

Are you planning any follow-up studies?

There will be real-world studies once the device is marketed.

I'm hoping that she unintentionally gave away here that there is currently no FDA requirement on the table for additional studies, especially since the crossover part was not considered for analysis (and likely submission...)

I'm starting to worry a little bit - it's been 12 months after completion of the study, 8 months since presenting the first results.

 

[Lurius]

Well, it was extremely disheartening to read that part of the inclusion criteria was an ability to modulate your tinnitus with neck and jaw movements and that your hearing loss can be no greater than -50 dB. If that's what's going to be the bottom line with the device, I might have to end it all, after all.

 

[Nick47]

I'm not enthused by the potential timelines. Was it really not possible to say if the device has been submitted for approval with the FDA, CE etc?

 

[Markku]

Was it really not possible to say if the device has been submitted for approval with the FDA, CE etc?

Nope. And she of course also consulted others in the company, so it's definitely company policy not to discuss it.

 

[Hardwell]

Interesting to hear that Dr. Shore has tinnitus herself, although she said hers was mild. It's crazy that she wouldn't want to try her own device. She did state that was because of conflict of interest, which I get, but oh man, that would be so hard for me!

Honestly, I fully understand this. Before my worsening I was at a stage with my tinnitus that I wouldn't have been tempted to alter it in anyway.

Well, it was extremely disheartening to read that part of the inclusion criteria was an ability to modulate your tinnitus with neck and jaw movements and that your hearing loss can be no greater than -50 dB. If that's what's going to be the bottom line with the device, I might have to end it all, after all.

This was known from the absolute beginning that those were the stipulations to be involved for the study. in regards to the modulation aspect, it doesn't mean it won't or can't work. It just means it's not been tested as of yet.

I'm not sure how the ability to modulate ties in to the treatment. My original tinnitus was easy to modulate. At its worst four months ago, after the worsening, I could not modulate it at all. It has eased off slightly and can now be modulated again at times. Again though, not all the time and not for all the tones.

Will the device work for me? Who knows. But it'll work for some people, quite possibly the majority. And that makes me happy that some people will find relief even if I don't myself.

 

[Ryan Scott]

I'm not enthused by the potential timelines. Was it really not possible to say if the device has been submitted for approval with the FDA, CE etc?

I have been feeling for a while now that we won't be seeing this device anytime soon. The 2 year time frame everyone figured seemed very optimistic to me.

 

[DeanD]

Well, it was extremely disheartening to read that part of the inclusion criteria was an ability to modulate your tinnitus with neck and jaw movements and that your hearing loss can be no greater than -50 dB. If that's what's going to be the bottom line with the device, I might have to end it all, after all.

I understand the modulation part, but I don't understand the dB limitation of the device.

If a person has severe hearing loss, why can the machine not transmit at a higher volume for those individuals - frequency may play a part in the modulation, but volume too?

Statistically, aren't those with the greatest hearing loss more susceptible to tinnitus in the first place?

 

[InNeedOfHelp]

From my understanding, even though speculation, I think the funding / investor is private equity and not big pharma. We need a large company behind this, focused on neuromodulation (such as Abbott Laboratories) to drive this launch.

We don't need a start-up driving this launch independently, dealing with regulatory approval across different countries, manufacturing/suppliers, logistics, audiologists, etc. It will take years to set up the logistics (look at Neuromod...).

Personally, based on thoughts and current known information (which is none), I think their fundraising route was done completely wrong, and a licensing agreement with a larger company would have made much more sense.

 

[Tomas80]

Many sufferers have suicidal thoughts. It seems inhumane to me that we don't even know an estimate of how many years we will have to wait for help, even though the device has been tested. It is extremely frustrating. The obstacle to my normal life is actually bureaucracy...

 

[eagerUser]

What does Dr. Shore mean by no one experiences true silence? Does she mean that even those without tinnitus don't experience silence or what? Or was she referring to the patients undergoing the treatment? We had an example of @kelpiemsp who experienced silence from a somewhat similar device (University of Minnesota).

 

[El BUZZ]

A question I would have liked to be addressed by Dr. Shore is: Would it be possible to (for example) use earbuds to listen to music at a moderate volume after having benefited from the device? I mean, any chances of going back to pre-onset habits after using the device with successful results?

 

[Josh59]

Doesn't anyone have a neighbour who has a friend, who in turn has a cousin, who knows someone working at the FDA to quickly validate Dr Shore's device?

In any case, great work @Markku & @Hazel!

I would have liked an answer to my question:

"Would excessive (even involuntary) stimulation of the mandibular, trigeminal, dorsal nerve trigger or accentuate the volume of somatosensory tinnitus already present? And why? Or is the aggravation only manifested by sound?"

Let's be patient, let's keep hope.

 

[lolkas]

I'm not enthused by the potential timelines. Was it really not possible to say if the device has been submitted for approval with the FDA, CE etc?

Well, by the looks of it, the device does work. Now, they obviously know more than we do about it, and if it is all that promising, then they are going to hide as much as they can before going to market with it.

Imagine this: you got something developed and tested, based on your testing it does really work and your local market has about roughly 40 million people whom would definitely give it a go. Even if this device costs out of pocket about $2,500, you would have a $100B market right there. This is insane. What about the rest of the world? It's like an ocean of money.

So I do understand their "secrecy" around this whole process.

On the other hand, there are XEN1101 and BHV-7000 that may potentially affect tinnitus in a positive way and in even more profound way than Dr. Shore's device can, even though XEN1101 and BHV-7000 are not developed specifically for tinnitus. If I were in Auricle's shoes, I would still keep everything low key and hurry up with the process, since you know - if XEN1101 and BHV-7000 come out around same time and do work - fewer people will turn to the device since the population is generally lazy.

 

[El BUZZ]

This thread is starting to feel like a revamped version of the Lenire one before Lenire was released...

May the outcome be a different one

 

[dj_newark]

What does Dr. Shore mean by no one experiences true silence? Does she mean that even those without tinnitus don't experience silence or what? Or was she referring to the patients undergoing the treatment?

I think what she means is that all silence is relative. Our bodies make noise and there are few places on earth that are truly quiet. At least that's my understanding of what she's said! I've had tinnitus for 34 years so I have no idea what quiet may be like at all!

I'm not enthused by the potential timelines. Was it really not possible to say if the device has been submitted for approval with the FDA, CE etc?

Think of it this way. There are known timelines for FDA approval of devices. De Novo devices are supposed to be approximately 150 days (give or take, it varies) and 510(K) is supposed to be decided on in 90 days (same, it varies).

Dr. Shore has stated that predicting when a device will be approved by the FDA is considered "marketing an unproven treatment" which could definitely harm the process with the FDA. And by confirming whether they've submitted to the FDA or not, it could be considered the same as predicting when the device could come out given what we know about the timelines for approval. It would be giving out too much information and could harm the process with the FDA. Loose lips sink ships! They are smart for being vague and noncommittal!

 

[ImmortalWombat]

Let's pray something comes out of this. Let this decade be the decade when tinnitus was cured.

 

[SarahMLFlemmer]

What does Dr. Shore mean by no one experiences true silence? Does she mean that even those without tinnitus don't experience silence or what? Or was she referring to the patients undergoing the treatment? We had an example of @kelpiemsp who experienced silence from a somewhat similar device (University of Minnesota).

We know what we had before tinnitus. I found her answer for this question a little odd too.

I think what she means is that all silence is relative. Our bodies make noise and there are few places on earth that are truly quiet. At least that's my understanding of what she's said! I've had tinnitus for 34 years so I have no idea what quiet may be like at all!

Silence to me is simply not hearing the ringing.

 

[Karl Tallman]

Has the federal government or any other other governmental institution taken interest in the device? Considering tinnitus is the #1 veterans' disability, has the government offered more funding to you?

Outside of the engagement with the FDA, there are no on-going collaborations with any other governmental division or entity

I'm glad someone asked this question and the answer truly shows how uncaring, incompetent, and ineffective our federal government is, especially the the US Veterans Administration!

One billion a year spent on tinnitus claims and along comes the first viable treatment for tinnitus in the history of warfare, yet administrative chiefs in that organization just sit there with their thumbs up their arse instead of pushing for funding to get this device out to the hundreds of thousands of vets suffering from deliberating tinnitus. Absolutely shameful and embarrassing! Heads should roll in that organization!

 

[Gb3]

I don't know why it's so hard to understand she can't answer hypothetical questions because she doesn't have the evidence to back it up.

 

[Watasha]

I'm glad someone asked this question and the answer truly shows how uncaring, incompetent, and ineffective our federal government is, especially the the US Veterans Administration!

One billion a year spent on tinnitus claims and along comes the first viable treatment for tinnitus in the history of warfare, yet administrative chiefs in that organization just sit there with their thumbs up their arse instead of pushing for funding to get this device out to the hundreds of thousands of vets suffering from deliberating tinnitus. Absolutely shameful and embarrassing! Heads should roll in that organization!

Email them, call your representative in Congress.

 

[Karl Tallman]

Email them, call your representative in Congress.

Yes, I should. I've always wondered why Veterans' associations in the US, and there must be many, have never campaigned aggressively for more funding for tinnitus research? If I had severe intrusive tinnitus that resulted from serving my country, I'd be raising bloody hell with my Senators and Congressional representatives to push for major research funding. I would think Veterans' associations would have a lot of clout and support from the public on this issue. Maybe they have campaigned and I don't know. Any veterans on here know the answer?