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Man’s a research-study-finding-machine.

Even large companies don’t tend to multi-submit. The amount of resources you’d need would be astronomical. Not only to prepare the submissions,...

Perhaps it’s best you find yourself another online community that aligns with your view. Tinnitus Talk is a support forum, not a place for you...

When it comes to the headphones question, there are a few important things to remember about the advice given on Tinnitus Talk: 1. Most of the...

For non-implantable devices and pharmaceuticals, the FDA scrutinizes patient safety instead of device efficacy. Basically, all they’re interested...

I would be surprised at that, to be honest. It is one thing saying it, but money talks. And the copycat devices will start to pop up soon.

This is a good take.

Depends on severity. If a major change, it may need re-submission. If it’s generally bug fixes and improvements that don’t affect the...

Nobody knows anything about Auricle. We don’t know if they’re contract manufacturing or doing it in-house. We don’t know what supply agreements...

I have to say, this means absolutely nothing to me. Gives me zero reason to doubt the device. I’m an analytical chemist. Not a programmer. But...

Fantastic, absolutely love to hear a success story. Would be good to know what you took/dosage so we may have the opportunity to see other...

33% success rate for a gen 1 device is still huge. I don’t think anybody here is expecting this to be a golden bullet. But if it works for 33% of...

[MEDIA]

Treatment 1 in Study 2 and Group 1 and 2 in Study 1 all agree. It looks like Treatment 2 in Study 2 are the outlier here with how little effect...

I suppose it’s all sort of inconsequential now anyway. We’re at the stage now that it’s a ‘it works or doesn’t’ as we’re waiting for regulatory...

For medical devices, the regulator is there to ensure patient safety. Auricle do have (supposed) clinical proof the device works and has no major...

It kinda does though. They chose 12 weeks for any other type of treatment as they would have no way of knowing the return to baseline time for...

You've obviously completely made your mind up, no matter what answers people try to give you. Not really sure what you're getting out of staying...

I posted a huge reply to that post but I decided to delete it. Glad I did as this says it better.

I checked the patent and found: The method of claim 4, further comprising applying the somatosensory stimulation signal to the subject by...

Unless specific data points are released, I don’t think we’ll ever really know the specifics to that level. I’m trying to look at this device...

Bluetooth suffers from audio latency up to 20x that of wired headphones. This can increase further depending on range and external factors such as...

Sorry to hear that. About the nerve thing, I wonder if this is why they paired it with Gabapentin?

Lenire’s head of R&D: WRITE THAT DOWN!!!

Good point. @gameover, don't stress about this too much either way. People that develop medical treatments like Dr. Shore don't really get...

Ah ok, thanks for the clarifications. I’m not sure why they would have done that for software like this, but I have to laugh as it hits close to...

Why do you think it’s a bit of a mess? The setup steps in the slides looks quite thorough and it’s obviously designed to be run with specific...

Because Lenire ‘trials’ were a total sham.

Doesn’t make you weak my man. You’re dealing with something there is no escape from, no shutting out and no turning off. I’m not saying it’ll...

I think it’s because she’s a scientist at heart and this is essentially her life’s work. She’s in charge and has taken her time to get things as...

Absolutely. My most recent ENT at a private hospital in the UK told me ‘there’s no glory for us ENTs in tinnitus as there’s no cure.’ But I also...

Good luck! I’m sure I’ve seen before that Lidocaine reduces tinnitus momentarily by itself, but I think this study is presenting the combination...

My residual inhibition works at any tone frequency. My 9.5 kHz tinnitus disappears even if I play a 400 Hz tone. I don’t think there will be a...

Nobody knows this, not even Dr. Shore. If your tone is 8 kHz and you can’t hear over 6 kHz, nobody knows what setting your tone at 6 kHz will...

Thank you for the correction, that’s really interesting! Could you tell me where that’s discussed as I’d like to educate myself on it.

I don’t think they changed timing, but instead the intensity of the pulses:

I asked this a few pages back. This is something I’m really interested in. For me it’s potentially one of the largest causes for any spread in...

That’s for the FDA to decide. They have similar modalities, but perhaps different enough to warranty separating them, i.e. different nerves. (I...

If you can predict that, play the lottery. Unfortunately, it’s an impossible question to answer.

Please cite an FDA source that agrees this (and I assume Lenire?) are equivalent substitutes. You don't make 'pre-arrangements'. It's one thing...

It does not matter how many people are suffering with this condition, approval takes as long as it takes. It does not matter that people get in...

I SO agree with this. One day I match my main tone at 4910 Hz and the the next day I’m like ‘wtf that’s way too low, it’s 5500 Hz’ today. Yet in...

Well done. Just to add: If the FDA require additional information (AI request) or have a list of questions (very common, I think the average...

I feel that’s because an objective measurement and a cure are intrinsically linked. A lot of conditions are discovered through analysis. For...

As per the patent, it appears to cover up to 24 kHz.

Right you are! Even better.

Not quite there yet, but I feel like we’re at risk of this thread becoming an echo chamber of negativity. Susan Shore never said this would...

Yep.

That’s great news. But I still wonder if you’d see on average a greater than 6 dB reduction within the same timeframe (for all tones) if you were...

I was having a daydream about this earlier (again). I am a believer that Dr. Shore’s device works as per the study data but is maybe just in its...

The website photo is a 3D render. Looks almost like an artist’s impression. Possibly either they don’t quite know the final form of the device yet...

It’s the same principal as Susan Shore’s device; same target nerve. It’s thought that maladaptive neuroplasticity is the root of tinnitus, so why...

The tinnitus device comes with a phone app. Would be nice to be able to change our tonal frequency with this as it appears the Michigan Device can...

To be fair, at least two people have had their tinnitus eliminated by the device in the first study, IIRC.

I kinda believe there isn’t much difference between early onset (which will then be chronic) and chronic. It’s the same thing, the only difference...

I’m genuinely happy this has worked for you. But I refuse to put my trust in a company that conducts the most comically selective ‘studies’ and...

ATA and BTA will probably hate it, because it’ll mean less donations for them to do sweet FA with. Instead, people will spend their money on Susan...

Unfortunately the objective, cold, hard truth is that Susan Shore owes us nothing. She has no requirement to keep us updated, although we’re all...

This isn’t pharmaceutical. Medical device doesn’t equal pharmaceutical. There are medical device manufacturers just as large as big pharma that...

I’m very much with you on this, I fall into the optimist camp too. Unfortunately these things do take time and people do tend to get anxious when...