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I would love to be wrong, but I do not think any weakening of the FDA will make much of a difference. I would love to see Lenire, with their fresh influx of funding, $10 million on top of the previous $33 million, license the technology from the University of Michigan for a next generation...

I've put it out of my mind and won't be holding my breath—if it happens, it happens. Any of the other approaches discussed in other threads on Tinnitus Talk are likely to come to market sooner. Everything that could be discussed has already been covered, so we might as well close this thread...

I wouldn't be surprised if Auricle were leveraging the expertise of their development/manufacturing partner who also provides FDA approval support, in2being. It would make sense for Auricle to use in2being given their familiarity with the details of the device and experience with the process...

Regarding the points above describing various inconsistencies in results, I have to hope that during all this time we're left waiting, there's some work going on to refine and fine-tune the treatment parameters for optimal results. It'd be pretty disappointing if the only thing happening is...

Maybe @Hazel can reach out for another update from Dr. Shore after some appropriate time period has elapsed since the last one? It might also be worth reaching out to Neuromod. They're enjoying considerable success right now and, from looking at their company profile and hiring activities, seem...

You could well be right, but they are also actively hiring bio-med and other engineers right now. The job descriptions mention developing next-gen devices.

It will be interesting to see what Neuromod is up to with their Lenire in the meantime - revenue is rolling in, they have electrical, mechanical, bio-med and software engineers on staff who are presumably working on something - improvements to current device, next-gen device, etc?

It's been said before, but I'll say it again - the most expedient and lowest risk approach to take, IMHO, would be to simply license the IP to Neuromod and sit back to enjoy the revenue stream. However, at this point I'd be surprised if Neuromod had any interest as they seem to be enjoying...

Nice little test on this website that will demonstrate what 6 dB increments in volume sound like - scroll down the page and click on the log level test. Please be careful with your speaker/headset volume setting before clicking: AudioCheck: The Non-Linearities of the Human Ear

in the end, it all boils down to money - bringing the product from prototype stage to something that can be manufactured reliably in volume, FDA (and other) regulatory approvals, launch onto market, enlisting audiologists and providing them with support, training, etc. It all adds up, that's...

Probably worth keeping an eye on this (or other similar venture funding focused sites) for funding status, etc (last funding round was $350K in 2021): PitchBook: Auricle Inc.

The other big unknown is Auricle, the company. No mention of funding on any of the Angel investor databases, the only known employee is the CEO (and maybe one of the PhD students involved in the study whose LinkedIn profile lists him as Head of Engineering for Auricle). It takes a long time and...

This pretty much sums it up! I'm just happy that it's now 2023 and we're starting to have some options to look forward to. After multiple disappointments from other potential treatments, I'm just happy to know that the research looks ever more robust and a tinnitus specific treatment is, in...

Couldn't agree more - be very careful. Mine was stable/non-somatic/unilateral until I had an accidental noise exposure that worsened my condition considerably. Now it's somatic, bi-lateral, much louder and highly reactive!

Great to hear - thanks!

I'm not concerned per se, but your observation kind of supports my point - it looks like a one-person organization with a registered company name and that's about it. There's a lot of work (and cost) to develop the current prototypes into a mass producible product, develop the supply chain, and...

Great to see it moving forward - I hope Auricle are capable of building what's needed to bring it to market in a timely fashion. FDA approval and building the device have reasonably deterministic timelines, it's getting the funding and building out the organization, infrastructure...

Understood re Lenire - I wasn't talking about adjusting to the tinnitus frequency, only amplitude - they do boost the signal at those frequencies where there's hearing loss.

Lenire's approach is similar to how hearing aids are customized for an individual's audiogram - they boost the signal where you have a dip to produce a profile that allows you to hear all frequencies at the correct volume. As previously mentioned, their system allows up to 80 dB loss. For Dr...

Don't rule it out - I saw a mention recently (I think somewhere on this forum) of data showing that a cochlear implant in one ear reduced tinnitus in both ears for a significant number of people.

Since she said FDA approval is being applied for, you would think this indicates that she must have some reasonable level of confidence in the efficacy. Hopefully a clearer picture will emerge going forward because, right now, what we know is that some presumably objective method to measure...

I'd hope that your hearing simply needs to be good enough to hear the sound at the appropriate level - Lenire has a limit of -80 dB at higher frequencies for this reason.

It's the difference between the world of academia and commerce - completely different motivations and measures of success. Papers published, peer recognition, etc vs. $$$. It seems time is rarely a consideration for academics. Unless you count 'within one's lifetime', and even then...

Where are the 100s of people that took part I wonder - all sworn to secrecy I assume! But I agree, the waiting game can be tough to take. I just try not to think about it and deal with it myself as best I can.

If it does turn out to be an improvement or enhancement over Lenire, if it were me, I'd enter into discussions on a technology licensing agreement. Neuromod have the manufacturing and logistics capability, audiologist network (soon to become global), brand recognition, solid financial backing...