New University of Michigan Tinnitus Discovery — Signal Timing

With all this talk of identifying your tinnitus frequency, is there any evidence the device plays sounds set to specifically target that frequency? It seems it just plays a broadband spectrum of frequencies?

Please enlighten me.

 

Yes, the device plays the exact frequency that could be matched to your tinnitus. Please refer to this paper.

However, please note that they cannot 'match' the frequency in animal model of tinnitus accurately either so if you can match it closely enough, you should be fine.

 

I wonder for those who have multiple tones/sounds, would they start with your most distressing tone, the tone that is most affected somatically, or the one that can be best matched to an actual output sound/tone? It will be interesting.

Wouldn't it be something/amazing once one sound is targeted and the “stuff” in the DCN is calmed, that sound AND the other tinnitus sounds ALL started to decrease together? Dream big! Lol.

 

There was another trial done by another group trying the same protocol by Dr. Shore, please refer to this paper.

They mentioned that "When multiple tinnitus sounds were perceived, it was suggested to concentrate on the most troublesome tinnitus sound."

Although this trial's results are a bit discouraging compared to the original trial by Dr. Shore, it must be noted the total duration of the therapy in this trial was just 3 weeks (total of 3 hours of bimodal stimulation) which I find to be very short and they admitted to that in the paper.

 

By this time next year, the device should be out. Hopefully it meets some of our expectations.

 

It took, what, 20 years of fundamental research and they invested $14M USD in this device? I think I read that somewhere. Can somebody confirm the numbers? It’s hard to believe it would not have any effect on tinnitus seeing these numbers...

 

If the device worked, wouldn't things be progressing at a quicker pace? I fear there's another 10 years of research needed before we get anything (as always).

 

This is exactly why I hope it's user programmable. Being able to do your 30 minute treatment at 2,000 Hz and then just pop it to 15,000 Hz for another 30 minutes to treat multiple tones would be the dream.

That... or buy two devices

 

No. It's gone to peer review. And it has had 2 successful phases already.

 

How do you propose to move it quicker?

 

Does anybody know if Dr. Shore's device could also help hissing tinnitus? Or is it designed only for tonal tinnitus? I have very loud intrusive hissing tinnitus beside my other tones.

 

No. The device passed Phase II with resounding success. Check out the thread on the Palm Springs Hearing Seminars for more information.

The paper for the trial is in peer review and will likely be published sometime later this year. No further trials will be needed before release. FDA approval for devices take months, not years (like medicines do). After the paper is published, my feeling is things will start to develop quickly. Dr. Shore wants this device to be released, but she's not known to rush things. However, I think the pace will pick up after the paper has been published.

 

My understanding is that it is for all forms of somatic (and maybe non-somatic) tinnitus.

 

I wouldn’t see why not. A high hiss could be matched with a very high frequency tone, however you’d probably have to be able to hear it played at least in one ear I’d assume.

Also, static is such a common sound that many have distress about so I wouldn’t be surprised if they have static programmed in there. I know if my intrusive, reactive, very high frequency tone/electric static was targeted and decreased, I’m more than half way happy/healed.

 

Is peer review and publication in medical journals required for FDA approval?

 

Well, this topic is a decade old. I don't see how things can move much slower. There doesn't exactly seem to be a rush to get the treatment to people, especially if this thing actually works. I guess we wait for the peer review, then something else, and be lucky to to find out in 2025 if it works or not. Hey ho, at the rate of progress, I won't have to worry my own mortality will fix the hearing issues.

 

I looked at the first few pages of this thread. I don't think these people who posted 10 years ago are on the forum now?

I wonder if they are still interested in the device?

 

It's because tinnitus is a complete joke to society and regulators. It's funny when you suffer.

 

2024. About a year. Probably private here, knowing the NHS.

 

In my experience I think many people suffer from tinnitus due to anxiety and hyperfocusing on it. They stop by for a bit and then leave and don't look back when it no longer bothers them. I fell into this category many years ago when I first noticed tinnitus and came here panicked and looking for a way to fix things without realizing how mild I had it.

My tinnitus was very manageable and light back then all things considered and here I am maybe 10 years later after a horrendous spike in February due to what I think was a virus that knocked out some of my hearing in my left ear. I now truly understand why many of you on Tinnitus Talk are so desperate for a cure/relief. It's very debilitating.

I don't know much about Dr. Shore's device but I'm not sure it would have any effect on my tinnitus as it's probable exacerbated by my slight hearing loss (not enough to warrant hearing aids though), I could be wrong about this so forgive my ignorance. I am hopefully that a drug like XEN1101 or something similar could help because, after the recent failures of Frequency Therapeutics, I doubt hair cell regeneration is around the corner.

 

The 3rd post on this thread from 10 years ago...

 

Wow, a whole 10 years ago I was only 8 with perfect health.

 

Absolutely not. I was near crucified for suggesting that publishing in a journal rather than focussing on regulatory approval and marketing the device was idiotic. Sure, publish after launch to back up your device. But you’ve already proven it in multiple studies. Funnily enough most of the people calling me out didn’t reply once I revealed I work for a Class III medical device manufacturer and know the regulatory approval inside and out. This device at best is Class II, so a lot easier to approve.

I’ll repeat myself anyway. As somebody who has multiple publications, you NEVER prioritise a publication over progressing to market. The only people I regularly see do this are university ventures. Universities place a MASSIVE amount of prestige on publications, and many people on this forum do too, when I have to say, in reality, any old tosh can be published.

Share the knowledge once you’re at market.

The FDA would laugh you out of the room if you tried to use a publication as proof of safety/efficacy. They want raw data, proof of validation, QMS etc. If, for example, the FDA give you a 483 deficiency letter, saying ‘but we’ve published’ isn’t gonna get you far. They’ll probably treat you with contempt, depending on auditor.

Is this what Dr. Shore’s team are doing? I don’t know. But if they haven’t received FDA approval by around August, I’d say there’s a good chance they delayed approval in lieu of publishing.

 

Corruption probably plays a part.

 

Your slight hearing loss shouldn’t be a problem. I believe they even allowed “mild hearing loss” participants in the study. As long as you can hear your targeted output sound from the head/ear piece, you “should” be good

 

2024 for the device to be out on the market is a pretty safe bet. That's what a lot of people seem to think, including myself. We shouldn't bank on that happening, but let's hope!

 

Thanks for clearing up that it's not necessary to publish in an academic journal before FDA approval. I thought it was important. In that case it may be approved earlier than I thought. They started working 'with' the FDA some time ago now.

The publication is likely to be important for health boards, on whether they approve it in their health services though. In Britain the NHS only approves treatments with a certain level of evidence and at a 'cost effective' price. Without good quality evidence these treatments end up at private clinics, Lenire as an example.

 

Thank you for mentioning Palm Springs Hearing Seminar. I was unaware of this.

 

I thought they were trying to get approval at least since early December?

 

I don’t think this is another Lenire though. It’s proven to work.

Tinnitus costs the NHS nearly a billion pounds a year. And that doesn’t factor in secondary issues like anxiety medication for people with tinnitus.

Depending on the device cost and NHS negotiating power, we may well see it on the NHS a year or two after launch.