That is why I wouldn't rule out a EU release before a US one.
That's amazing. Were those people part of the 20 people of the first study in 2017? Or was that some independent study?
The rules for FDA approval for medical devices are not the same for medicinal use and devices. For medicinal use it takes years, even over a decade to bring a device to market. For devices the rules are very different and a device can be approved in as little as 6 months! I wouldn't bank on an EU release before a US release given that it's being developed in the US and FDA approval device was already set in motion years ago. It can't be finalized of course until the device is released!
They can't sell it before it gets FDA approval. But there will be no Phase III before it's sold.
I know, but EU CE is even more relaxed and shorter timeframes than FDA rules for Grade 2 devices.
Ok. That's true. It does depend a lot on who licenses the technology. I still think it's going to be a US first product though, and that's not just wishful thinking. They are pursuing the equivalent organizations to the FDA in a lot of countries, I think they'll want to roll it out to as much of the world as quickly as they can. I know they have patents for the device in a number of countries around the world.
No. Only two phases for medical devices. They will have to get FDA approval. The process is under the DeNovo pathway. Details of that are here:
That question has already been asked a dozen times. I'm curious about this myself. I have a Zoom meeting with Prof. Dirk De Ridder in October, I will ask him his opinion about it. Although the only one who really knows the answer to this is probably Dr. Shore. But the way I see it, it's all in the brain so I don't see why it shouldn't help everyone.
It would be good to have an updated opening post with all the information currently available because many of these questions come by every few pages. Please take your time to read through the last 10-15 pages. But since you are new and I don't want to scare you away:
Still worked for them. I wouldn't worry about this.
One additional point, I don't believe that the source of the tinnitus (as long as there wasn't a tumor, etc) was one of the qualifying or disqualifying criteria for taking part in this study. I don't believe anything in her papers suggests that her tech is more geared towards noising induced damage as opposed to ototoxic, or anything else. The targeting of somatic tinnitus sufferers was based upon the assumption that those who can already impact their tinnitus by physically pulling of nerves on the face and neck would be promising candidates for the stimulation of those same nerves. The selection of somatic tinnitus sufferers in the study does not exclude that it may be equally impactful on non-somatic tinnitus. It just wasn't tested.- Most of Dr. Shore's research is exclusively around noise induced tinnitus, including this device. It was tested on noise exposed guinea pigs.
- This specific device is not tested on people without somatic tinnitus. But we don't know if the guinea pigs that this was tested on had somatic tinnitus either. Guinea pigs don't talk
- A different bimodal device tested on a Belgian university showed that their device worked the same of somatic or non-somatic tinnitus.
- It would (my theory, not scientifically studied) make sense if it might work slightly better on people with somatic tinnitus - these people might be more senstive to the electroshock stimuli applied since they can already modulate on their own without help.
Regarding the earlier discussion on Phase 2/3. Phase 3 is not required by law but I really wouldn't be surprised if a third study would follow. Perhaps in parallel to the launch.
Thanks, this is helpful. Do you know if the device could be helpful for low frequency / humming tinnitus or is this more targeted towards the traditional higher pitched ringing tinnitus?- Most of Dr. Shore's research is exclusively around noise induced tinnitus, including this device. It was tested on noise exposed guinea pigs.
- This specific device is not tested on people without somatic tinnitus. But we don't know if the guinea pigs that this was tested on had somatic tinnitus either. Guinea pigs don't talk
- A different bimodal device tested on a Belgian university showed that their device worked the same of somatic or non-somatic tinnitus.
- It would (my theory, not scientifically studied) make sense if it might work slightly better on people with somatic tinnitus - these people might be more senstive to the electroshock stimuli applied since they can already modulate on their own without help.
Regarding the earlier discussion on Phase 2/3. Phase 3 is not required by law but I really wouldn't be surprised if a third study would follow. Perhaps in parallel to the launch.
Noise induced tinnitus IS somatic tinnitus in a lot of cases. All you need to do is see if your tinnitus changes when you clench your jaw, press on your face or make movements with your head. If that's the case then you have somatic tinnitus, whether it was noise induced or not!
Err, 20 years research from a university will trump some jumped up entrepreneur. I think it will be a decimate improvement on Lenire, no doubts.
That's the stupidest thing I've ever read about these devices and I've read a lot. Shows once again how clueless even the most "knowledgeable" doctors/researchers/etc are about tinnitus.
No. It's not the same concept. I suspect a lot of what Dr. De Ridder says because he is frequently wrong!
I am not sure about reactive tinnitus. But it will not treat pulsatile tinnitus.
I am less familiar with pulsatile tinnitus. You are right. So, Dr. Shore's device won't be able to treat that, but there are at least existing avenues for treatment.
What device was this? Could you elaborate or, if you have any more information, could you provide it?
there is a subset of somatic tinnitus called somatosensory pulsatile tinnitus whereby the DCN no longer cancels somatosensory sounds hence modulation of sounds through muscle or joint movements. The other theory is that the auditory pathway/brain taps into existing somatic pathways to maintain neural pathways.
Her clinical trial isn't necessarily the same as commercial use but...
Cool. That sounds like I would qualify. I have only mild to moderate mid-range hearing loss, also known as a "cookie bite" hearing loss, and then another moderate drop off in the higher frequencies of around 13,000-14,000 Hz. And presumably that's where the majority of my tinnitus lives.
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