New University of Michigan Tinnitus Discovery — Signal Timing

Because everybody's "cured" it in mice. Any company past or present in the tinnitus game had to show some positive results in animals before moving to humans. Hough also has cured it in mice.

Lots of ailments can be cured in animal subjects and it doesn't translate to humans.

Honestly, I'm sorry to nay say. I hate reading posts on here that do. Yes, I'm suffering and frustrated. Having recently been turned down from OTO-313's trial because I have bilateral tinnitus, and Frequency Therapeutics because I don't have the "right" hearing loss - yeah, I'm pissed. To be honest, I'm really sick of companies being irresponsive to inquiries, withholding info, like Frequency Therapeutics not disclosing exactly what hearing loss one needs to be eligible, or Otonomy why you need unilateral. At least with Hough I get responses quickly.

I think 3 years is odd to test a device that shocks you and plays noise in your ear. 1 year should be enough to say "we're experiencing really positive results" or "things are going slower than we thought.". I mean, being that we aren't injecting a drug into our system, the test group should be huge. It either provides relief or it doesn't.

Yes, I know I'm not a scientist. I just can't take coming on here and reading page after page after page of speculations, and basically no hope or info being offered from these companies.

I think I got spoiled in a way at first. It was like ok we have this company Frequency Therapeutics. Well they're well funded now... ok they're public now, ok wow they're testing in my home town. Then I get cut. Well, we have Otonomy. Nope. I can't. It's just set back after setback. And speculation after speculation.

That's why I'm becoming pretty impatient or short winded with people making claims about so and so curing it in an animal, or whether or not it's in the brain or the ear.

For a while I felt like I was right in the sweet spot of a cure coming and now I've lost hope. I'm tired of trying to heal this wound and I can't.

 

Unfortunately Dr. Shore, unlike Lenire, has been in no hurry to have her version of this therapy commercialised.

She's been at this for nearly two decades after the initial tinnitus neuromodulation results came out of the University of Minnesota. And she's had successful results on humans for years now.

She's stated that she's had to wait for funding, through her university, before she can move onto the next stage of testing. Never any mention of co-opting commercial investment funds to kick this along, until quite recently.

Not doubting her careful methodical process in her work, but frankly, she has dragged her feet with her device. I don't understand why. Is it a consequence professorial tenure? That you get your salary paid regardless of whether your research is commercialised or not. I can only speculate.

If Dr. Shore had sought investor funding as researchers usually do when they have strong proof of concept, her machine could have been on the market well and truly by now.

 

Have you tried the device out and have you noticed any improvements?

 

I understand the frustration. I completely understand where you're coming from, but feeding into the negativity will not help. It's best to try and be realistic and accept that we're going to have to keep waiting for something to really help. That's why I've been trying to habituate to my nearly unmaskable tinnitus, not much luck yet but I have comfort in knowing that help could come sometime in the next few years, maybe even as soon as next year if Dr. Shore finally commercializes her device.

As Dr. Shore said, basic science comes from animal testing first. Yes it's a shame they are only barely getting this down but it's not like it's their fault, this condition has never really been taken seriously by the medical community. Only more recently is it getting a little bigger, and I think in large part to being a veteran disability.

Where we are now is still better than in the past. Imagine if you were alive and got this 20 years ago? Back then there wasn't even any "cured in mice". Just "get used to it" from the doctors. Even when I talked to an ENT when I first got this, that's pretty much what she said! I had to inform her of all the research going on. She didn't even know about any of it.

The truth is these companies are under no obligation to get back to our inquiries, and have set up there clinical trial requirements for a reason. The end product once on the market will likely not be of the same requirements, and even the next phase will probably have different requirements.

All of these are still experimental, even if we are accepted we can't have a "I'm gonna be cured" mentality. Though I'm trying out OTO-313, I understand I might only get the placebo. Even if I do end up with the real drug, I'm mentally prepared that it might not do anything. That's why it's still in trials, they're not even sure if it works yet.

What does looks like it works is Dr. Shore's device, and I am a little upset that it's been taking so long for this to move forward and get into people's hands. They know we are suffering, some of us much harder than others, yet there is still much red tape placed in front of them and they probably could be doing more to get past it.

 

Are you worried about any side effects with trying OTO-313? Did you have to sign an NDA?

 

I had to educate my ENT on developing treatments just about a month ago... he didn't even realize that they were testing Otonomy and Frequency Therapeutics under their own umbrella. I told HIM about it!

What sucks is if you go back to the early pages of the research forum here, we're all talking hopeful back in 2012.

I get it. This is a supremely hard nut to crack. But I need more PR and dialogue from the leaders of this research. I want to know failures as much as successes. I want to have feedback. But it's all this speculative bullshit. "Seems like this could work, but, we don't know. We need to try more of this, once we get funding". And then that's over.

Sorry. Nobody needs to hear me vent. Trust me. I was DELICATELY hanging onto positivity just a few weeks ago. I still do. I'm happy that tinnitus is starting to get more attention.

Last night NPR did a show about hearing loss and tinnitus. The guest didn't provide any news to us, but one interesting thing I took away - they studied tribes of people who weren't exposed to the modern world - and the elderly had just as good hearing as an infant.

 

Doctors learn mostly from laboratories. They provide them with information about drugs, treatments and their side effects. Years ago a dermatologist mistakenly gave me the information she had about Accutane. In the booklet the laboratory explained everything she had to explain to me, step by step. Really poor and easy to understand. That's why doctors then deny side effects so easily.

I had to update a prestigious ENT, a "tinnitus specialist", in my country about Lenire.

 

Let's say that Lenire comes to America. Can't Susan Shore skip the rest of the trials like Phase 3 under the 510(k) process? Many medical devices have gotten approved a lot faster because of this. So if they get the timing down in Phase 2 and they see no need for a Phase 3, let Lenire come in and then tell the FDA that the device is "substantially equivalent" to one that is now allowed on the market. It would save costs and get Michigan's and maybe Minnesota's device to market faster. Just a thought.

 

But what was the life expectancy of these people? I bet it was much lower than that of the modern world.

BUT I do get your point!! The modern world has wrecked our hearing.

 

I asked about that and they said they already tested it in 50 people and no one got worse or had any significant side effects. In fact they told me some people started getting better. Only common headaches and things like that were what they saw, from getting the shot itself (even placebo saw these as they are common with ear shots).

Basically I asked if I should freeze some sperm and they said I won't have to.

About the NDA, I was looking out for it and I actually don't remember seeing it. I might have to do it the next time I go but I'll ask.

 

Email her man, I'm not sure but I think the FDA is already looking at her device but she might be able to give you a better response to that question!

https://medicine.umich.edu/dept/khri/susan-e-shore-phd

 

Yeah I saw those, but a lot of the things they were looking at were things we still are now, just they were in the very early stages now it's a little better for us because they are at least in the later stages, might release soon, or even are being released (neuromod but we know the jury is still out on that one).

 

Hey everyone. I just got a message from the University of Michigan about participating in the trial for bi-modal stimulation. I'll try and provide updates as the situation progress's. I'm not super up to date on the thread as it's 50 pages long, so I'm sorry if this is old news.

https://umhealthresearch.org/index.html#studies/HUM00143675
^^ This is what I'm referring too.

 

Is the trial actively recruiting now? Did the trial start yet?
(I’m having a lot of trouble locating accurate online info on this.)

 

Yes it is, you have to live within 100 miles of Ann Arbor, Michigan and preferably tinnitus of 6 months to a year.

I'll be honest and say that I've thought about moving over there to participate lol

 

No clonazepam usage in 6 months. They denied me for that.

 

Way to go!

Dr. Shore has it down. I bet you're about to have some quiet moments.

Let us know exactly how quiet it gets!

 

Oh my god, they explained why they avoid the use of benzos?

 

Oh yeah, I forget about the drugs. I heard of denial for some ADs before though.

Did they say why? Is it because some people report tinnitus changing with it?

 

I guess benzos can affect neuroplasticity.

 

They did not explain. I’m assuming Don Tinny is probably right.

 

These companies are pickier than hell about participants. I mean let somebody try it, if it works for them great, if not, make note of their specific traits and it could be why it failed for them.

 

It's not a company it's a university, and they probably have good reason for it.

 

I was referring to all the current ones in clinical trials - which are turning down people left and right for no apparent reason other than you don't quite meet our requirements.

I believe I read that even Dr. Susan Shore prefers unilateral tinnitus sufferers for this trial. I just don't get it. With as little that's known about tinnitus - I don't see the harm in letting as many different cases try it. Sure, label and categorize participants as such, but... in my opinion these trials should try as many different groups as possible. We don't know what we don't know.

It seems especially frustrating when we're talking about a device. I'd pay money just to have the chance to try it.

 

I've seen a lot of comments like this lately--not just picking on you lol--and I understand where it's coming from, we're mostly all in the same boat--some better and some far worse for sure.

But you can't do science that way. You have to establish a baseline removing as many variables as possible, then once you think you understand you can build out from that foundation. Cheers to all.

 

Got my email back.

“Thank you for your responses.

Although we are still actively recruiting subjects for our pivotal FDA clinical study and I appreciate your interest in participation, our inclusion criteria unfortunately require that participants’ permanent residence be within 100 miles of the study site. Our governing IRB also does not allow for our subjects to relocate in order to participate at this time. The protocol stipulates that participants come to the study site for weekly visits and evaluation during the 6-month treatment period, so this is why we require that participants reside nearby as extended travel or moving can negatively impact tinnitus.”

 

...

Humph. That’s...weird?

 

Just move first then inquire for the forms after. They won't know you just moved.

 

I never even got a response from the doctor.

I’m about 150 miles unfortunately.

 

Unfortunately it’s too late for that. I had already mentioned the move and my email has my full name. I didn’t realize they had completely excluded those willing to move - I thought they only had a preference for current residents.