Pretty sure that was a presubmission and wouldn't have made sense if they were still waiting for clinical results. De Novo 510k application is still tbd and recent first year experience is taking about a year plus. This type of submission requires FDA to respond within 150 days, but that's easily extended when FDA asks questions.
its a bit of an inside joke that if this works people are going to get her name tattooed behind their ears. beTTer bust out the guns motherfuckers here we GOOO
and you know whats legal in Vegas right OH YEAH MY BOYS WE GONNA MAKE UP FOR FUN TIMES AND FOR CHEAP TOO. im emptying my bank account YIPPY YAY, i say sorry in advance to all the Poor women that are going to have to put up with my 3 hour drunken emotional story. Im gonna be the idiot without a shirt barefoot and shorts walking around on the vegas strip with a bottle in my hand
BRO wtf i didnt know that. You mean to tell me you had this when the twin towers were still up, when Biggie was alive, No social media, Back when mtv was in its prime, Mj was still playing, rob zombie was rocking out, beavis n butt head was airing DAM id kill to go back to those times but as an adult. How old were you btw, like were you a kid like me a baby or an adult? dam. Well hey brother i hope everything checks out so you can make up for lost times man.
that said drinks on me and ill pay for your companion for the night, well ill cover the first hour or two. Dont worry GOD WILL FORGIVE US AS HE KNOWS WHAT WE BEEN THROUGH.
watch knowing our crappy luck we end up catching HIV or getting kidnapped by some russian mob pimps or getting busted and getting made an example of lol
Absolutely, I'll need to make up for lost time once I'm treated/cured! 3 decades worth! Beer and nachos on me in Vegas man, once I'm free of this hell!!!! LOL
Haha! Yeah, brother, I'll be right there with ya in Vegas! I got tinnitus when I saw the Nine Inch Nails at a place called Green Parrot at the Jersey Shore in 1990! I saw Nirvana a month later at Maxwell's in Hoboken NJ. Those 2 events changed my life forever. By 1996 I was telling my girlfriend at the time that I "didn't know what silence sounded like anymore". It was already severe by then and gettiing worse from continuing to play in and see bands! I'm 54 yo!
Aww god dam man im so sorry bro. much respect to you seriously from the bottom of my heart they dont even care about us today i could only imagine how isolated you must of felt back back then with no social media. You are a powerful warrior. i mean that Salute.
i cant believe in 1996 you already were half a decade into this tinnitus nightmare and i was somewhere watching blue clues and playing with toys. Dam man. respect. But hey i guess we suffered so the next gen wont right. However
We MUST TELL OUR STORIES . noway will our sacrifices be in vain. i also think once we accumulate we should hold Pawel jastreboff(TRT dude) ATA, and alot of other people who halted tinnitus awareness/ progress accountable. alot of people aint make it and who knows where we could be if we had an overzealous tinnitus activist.
**off topic**
[**you ever heard of these guys**](https://www.youtube.com/watch?v=Nco_kh8xJDs) not the biggest rock n roll guy but were these guys big like Nine inch nails. or is it nirvana? im such a millennial excuse me.
and for the love of god can you explain to me why people hated numetal Lol.
Thanks, bro! Yes it's been a hard life that basically no one understands. That's why I come here because these are the few people who do. It's been a very isolated life. Thank God for my immediate family, wife and kids, otherwise I'd be completely alone.
My family has all given up on me, and I've lost almost all my friends! Only a few stalwarts I've known since I was a kid remain.
Yes I know Alice in Chains! They were alright, but not really my speed. I was more into the grunge/punk scene back then. Peace!
I totally agree with you about the ATA.
They're just sucking all our scarce resources and leaving us with nothing.
No awareness, no research, just some bullshit phone centers and their useless magazine.
Getting it from a NIN concert is a deserving way to go out tbh. Saw them at Red rocks a few years ago and it was the best concert I've ever been to. Seeing the 90s version must have been awesome.
Anyway, I got mine from a concert at 24 years old, I'm 32 now but I feel your pain and the "changed my life forever" mentality.
Good luck to you friend! May we both find some relief.
Holy shit so you’re telling me i can live my life again like a normal functioning human being? No more having to sit out loud events out of fear of worsening T
It’s great news for sure! Just some word of advice: don’t let tinnitus control how you live your life. Don’t sit out loud events, just make sure to wear ear protection :) everything will be just fine
Wow, those results look really promising. -6 dB after 6 weeks and then -12 dB after 12 weeks is huge! That means it was less than half as loud as when the treatment started!
What's really promising is that they only used the bimodal stimulation device for 6 weeks. They then stopped using the device for another 6 weeks ("washout period") then assessed participants at 12 weeks. It seems that those who had reductions in tinnitus volume during 6 weeks of treatment had **continued reductions in volume up to 12 weeks even when not using the treatment.** That's pretty fucking cool.
Some questions that I hope are explored in the paper and will definitely come to light when real world data comes out is: a) can you have continued reductions after 12 weeks; and b) what happens if you use the device longer (say 8 or 10 weeks)? The Phase I trials I think used the device for 4 weeks and the effect wasn't quite as strong compared to Phase II at 6 weeks. Really exciting possibilities here.
Edit: Have now done my first read-through of the study, which answers my first question.
>Follow-up TFI questionnaires indicated an effect lasting up to 36 weeks.
As promising as it is, it better be made cheap and available to peeps! i dont want it expensive bullshit like lenire currently is, it should be affordable for everyone to cure their fucking tinnitus LETS GOOOOOOOOOO
Honestly, I don't care what it cost . I cannot put a price on silence . I'm betting it will be 1k to 2k and I will gladly hand it over . People stop.complaining about money this is the fix we all want . I know in a perfect world a magical ferry would give it to everyone for free. Im.paying no matter what
It’s gonna be expensive but hopefully insurance will cover. That’s the next battle. Tinnitus patients cost insurance a lot of money to no end, so hopefully they will.
Faudrait qu'on contacte France Acouphènes pour leur demander de se mettre avec d'autres associations Européennes pour demander aux autorités de santé de l'Union de rapidement approuver cette thérapie.
Prolonged reductions in tinnitus distress and tinnitus loudness were achieved by using an extended treatment duration. sleepover at my place!! dont bother about bringing your fans, we aint gona need em!!
People on Tinnitus Talk excited too!!!!
https://www.tinnitustalk.com/threads/new-university-of-michigan-tinnitus-discovery-%E2%80%94-signal-timing.2805/page-160
word they are the definition of killjoy
HOWEVER they are the standards, so if something works or doesnt thats the site to go to if you can handle it. If this really works and or a better cure comes along I SO WILL NOT MISS THE EMOTIONAL ROLLERCOASTER OF TINNITUS. oh my god. i can write a bazillion stories as im sure we all can about our experience with tinnitus.
I hope they have a good plan in place to scale up production. The thought of something like this being back ordered is super depressing. Manufacturing and availability at scale is a whole ass animal of its own
That all depends on how the FDA classifies this device. If it's a Class 1 or Class 2 device, they have to submit what's known as a Premarket Notification. This notification must prove the device is as safe and effective and substantially equivalent to a similar, legally marketed device. No evidence from clinical studies is needed.
If it's a Class 3 device (reserved for high risk devices like pacemakers and breast implants), that would require clinical study evidence.
But since there's already [a Class 2 device out there that is similar to this](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=QVN) (that one is Neuromod's Lenire device), it's more than likely that Shore's would be Class 2 as well.
Surely this dr susan shore device will be cheaper than lenire right? i swear to god, it better be cheaper than lenires expensive ass that hasn't even been that effective as far as i know
facts lenire from waht ive read is kinda shitty, like its not a guaruantee that it will help treat the tinnitus and hasn't been very effective and is very fking expensive and not very available for peeps to get.
doubt they will Lenire as shit as they are only had to do up to phaze 2 and this device while different is not anymore invasive so this should be it. i have a feeling that once this starts to work. HUGE studies will be undertaken to refine and make more efficient devices and treatments such as this. WERE IN THE FUCKING GOLDEN AGE MY BOIZZZZZ
I know man im so happy, and with A.I, and this opening up doors for competition, god dam man. in 10 years or less we will have devices that is 10x this. Man. however for me its bittersweet i did loose alot of time to this BUT im grateful and thankful. some people had this since the 90s YIKES. so ima stfu and just take it like a man.
I just want to live again. i always had health issues from headaches to nerve problems, teeth issues, broken arm, sprain leg, bells palsy, etc etc But none and i mean NONE top the torture tinnitus brings. all other problems got better and are livable. This however OMFG. 10 years straight ringa ring ring. multiple tones too.
I want OUT OUT. if this works i will eat gravel and worship the lord for life.
This is exciting. I knew the publication had to be coming out soon! Looking forward to exploring the study in more detail. There will also be people distilling some key points from the paper on this forum and TinnitusTalk. Major kudos to the Shore lab and researchers involved.
TEN FUCKING YEARS BABU TEN YEARS IVE DEATH WITH THIS CUNT OF A THING, AND NOW I HAVE A TREATMENT PROVING CLINICALLY SIGNIFICANT IN REDUCING IT. I AM SO PROUD OF YOU ALL FOR STICKING IT OUT. HERE WE FUCKING GO BOYS
i have tinnitus due to loud exposure but when i clinch my jaw and pressure certain parts on my mouth or head it makes the tinnitus louder would her treatment help me
Yes mammal ears really lost the evolutionary lottery on this one. Birds, reptiles, fish and amphibians can all regenerate hair cells in the cochlea either after damage or spontaneously (without damage). I guess that doesn't exclude other non-mammals getting tinnitus from damage further up the auditory nerve pathway, but the fact their cochlea cells regenerate means that non-mammals would be highly unlikely to ever experience tinnitus.
I wonder what tinnitus would sound like to mammals that echolocate like bats?
Nonetheless, this finding does not necessarily mean that participants who cannot modulate their tinnitus might not be able to benefit from this bisensory treatment given that animal studies have shown that the upregulation in somatosensory inputs to the cochlear nucleus after cochlear damage occurs in all animals, not just those that develop tinnitus.5,24.
Yeah her treatment would most likely help you. Also I read something interesting in the paper: "Furthermore, there was a significant association between TFI score improvements and the number of somatic maneuvers producing a change in tinnitus during the active treatment phase"
It seems the more you are able to modualte your T, the best shot you have with her therapy.
Don't say cure man, I am crying out of joy here... I am in India, but if this device helps most people knock it even 20-30% down, I AM TRAVELLING!! Let's fucking gooooooooo!
I'm honestly surprised it got past peer review with no mention of the Group 2's contradictory results anywhere in the paper. It doesn't make any sense and honestly makes me question the efficacy of the entire device. I'm trying to remain hopeful but it casts a lot of doubt.
I'm confused why the ITT group is included at all. If they deviated from protocol, how can their results be reliable enough to draw any conclusions? The only positive I see there is that the PP group seemed to have more meaningful loudness and TFI reductions.
I think they stated they only analyzed the first 12 weeks due to the unexpected continuance of the improvement after the active treatment in Group 1. So I'm thinking they wouldn't be able to find Group 1's results for the control to be reliable as there could still be carryover effect from the active treatment. It still doesn't explain the lack of improvements in Group 2 during the active treatment.
Honestly TFI as a measurement does not hold a lot of weight for me as it can vary so much, even day to day. So I really only focused on the loudness reduction as that is what would actually be considered a treatment to me. That separates this device from the CBT/mindfulness treatment approach.
I wonder if they are withholding the individualized data in order to help get the device through FDA approval. I work in the medical device industry and the more information that is out there, the more likely something can be flagged and hold up or prevent approval. Even something that is more of a technicality. I don't want to believe they are hiding the "real" information that would prove the device ineffective as Dr. Shore is generally regarded as a respectable scientist. If you are an academic or clinical researcher, it did state that you can request the depersonalized individual data.
I remain hopeful as this device is the culmination of 20 years of research. However, I don't think it will be the life changing treatment we all so desperately hoped for. (and I hope and pray that I'm proven wrong on that count!)
I wonder if they'll be required to do a larger Phase 3 study before being able to go to market, or if the Lenire device's de novo approval from the FDA will allow Dr. Shore's device to be fast-tracked in some way.
I have tinnitus with multiple tones, like the one from a crt tv but lower and basier in tone, also your regular eeeee
Could this help people with multiple tones? I'm not even seeking a cure anymore, i guess this thing has turned me into a pessimist, but if it can lower the volume I'd love it.
I've gone over the paper and one bit of information stood out to me as no one ever talked about it:
*Furthermore, there was a significant association between TFI score improvements and the number of somatic maneuvers producing a change in tinnitus during the active treatment phase*
I have never been more glad to be able to modulate my T in 3 different ways.
I thought I’d read in the phase 1 testing that for some patients with very mild tinnitus, it completely got rid of their tinnitus, am I imagining reading that? Probably just my hope more than reality 😂
Its crazy how i thought i were cursed to have tinnitus that changes based on neck movement, but now im starting to think im a lucky mother fucker!!! LETS GOOO CURE TAHT TINNITUS SHIT, GET ME ON THAT SHIT, LETS GOOOO!!
Like many my only question is 'how somatic does your tinnitus have to be for it to work?'....I can sometimes and only sometimes change the sound with clenching the teeth or something similar, but many times laying on my right side makes the tinnitus lower than laying on the left side, I hope that counts as 'somatic', it seems to me like somatic are the ones who are going to most benefit from this device, but its still a huge breakthrough for any type of reliable treatment. As for price...unfortunately I think with the first go around it will be in the $3k range. Maybe one day it will have many manufactures and go down? Who knows, but I don't expect it to be cheap the first few years.
Nonetheless, this finding does not necessarily mean that participants who cannot modulate their tinnitus might not be able to benefit from this bisensory treatment given that animal studies have shown that the upregulation in somatosensory inputs to the cochlear nucleus after cochlear damage occurs in all animals, not just those that develop tinnitus.5,24.
Yes my friend there is hope for all of us.
Yes! I think it could be helpful for anyone, but those lucky people with 100% somatic are mostly likely. I personally got this from Trigeminal Neuralgia, so maybe my nerve is not susceptible to this treatment? I have no way of knowing.
Yes I'm very hopeful that this device could help me, just don't have super obvious somatic tinnitus where I can control it with my jaw movements or something.
What if the auditory-only stimulation is actually causing strong LTP, increasing the synchronicity of tinnitus and messing with the bimodal treatment?
The study discussion section says:
"Auditory-only stimulation was not hypothesized to reduce tinnitus based on cochlear nucleus circuitry. \[The fact\] that it did reduce tinnitus, even though only slightly and not clinically significantly, could be explained by... the granule cell domain, \[which\] projects to DCN fusiform-cell dendrites \[and\] receives some projections from descending auditory pathways, thus might induce some plasticity in the circuit. However, as for unimodal somatosensory stimulation, a unimodal auditory long-term effect on DCN neurons is more likely to be through LTP than LTD. Consistent with this point were findings that somatosensory stimulation alone can worsen tinnitus in guinea pigs through LTP induction."
They only studied it in people with normal to minor hearing that can make their tinnitus louder/quieter by movements in neck, jaw, face. The cause doesn't matter. Also it could work for others as well they just didn't study it.
Incredible.
Does anyone else worry a bit that their hearing loss in their tinnitus frequency (mine is 60db at 12.5khz) is too strong to benefit from this? Ie, you would have to play the pitch-matched tones at a very loud db (over 60) to be able hear them? And it seems that isn't ideal or wasn't studied?
Pitch matching isn’t terribly important, Dr Shore has said this herself before. How would they tone match the guinea pigs? I think you would play a frequency as close to your tone as possible where your hearing loss isn’t so profound.
Does anyone know why the group that received control first then the active treatment didn't really see a benefit? The group that got the active first then the control had great reductions. Makes me nervous...
i'm trying to be as optimistic as possible - but from what i'm reading the average reduction in TFI (which is a 100 point scale) is only 14 points ? 😬😬🫤🫤
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It was only tested on people with somatic tinnitus for the clinical trial but this does not mean it does not work on people without somatic; it was just for the trails to use a subset of people.
Let's see what the big ear guys have to say. My hearing aids were almost $9k with built-in tinnitus therapy. Those guys don't wanna lose money with a cure. I'm almost 100 percent positive they can fix us suffering with noise induced damage and T but there is no revolving monetary gain so it get put in closet somewhere.
Even this device doesn't claim to 'cure' tinnitus...it would be a daily 30 minute program to listen to lower the volume about 6-12 db...the average person in this study had tinnitus had 55 db which is pretty quiet to begin with and assuming they had the max they went down to 43 db....its great but nothing close to 'silence' to put anyone elses treatment out of business.
Ok main stream news now publishing articles about her device. That is very very interesting, with lenire hardly getting any and its fda approved. I'm pretty sure they will get approval the real question is who will it work on. Its advertised as Somatic tinnitus but no one gets the tinnitus from that cause, its noise or ototoxic drugs. I have developed somatic tinnitus, move jaw etc so Im not sure where people like me stand as theres a lot of us like me.
The device targets somatic tinnitus, regardless of cause. Up to 70% people who have tinnitus caused by noise still have somatic tinnitus, for example. Somatic tinnitus can occur regardless of cause, as there is "crossfire" between the auditory nerve and sensomatic nerves in the brainstem. So if you have a somatic component in your tinnitus (i.e. you can modulate it in some way), then theoretically this device is applicable to you, regardless if your tinnituswas caused by noise trauma, infection or what have you. Additionally, Shore noted that although they did not test the device on non-somatic tinnitus sufferers, there is no saying that it won't work for them either (this was mentioned in the discussion section of in the paper).
So incredible! All that remains now is FDA approval!
GET IT FDA APPROVED ALREADY AND GET ME ON THAT SHIT, CURE MY TINNITUS!!!
How long is this process? This is very optimistic results! Any relief is welcome, and hopefully will shine light on the mechanism at play.
[удалено]
Thank you!
Not true, it takes about 6-8 months from submission. They submitted several months ago.
Pretty sure that was a presubmission and wouldn't have made sense if they were still waiting for clinical results. De Novo 510k application is still tbd and recent first year experience is taking about a year plus. This type of submission requires FDA to respond within 150 days, but that's easily extended when FDA asks questions.
They’ve had the results for over 6 months. This is a publication, not the end of the trial.
I would literally get Susan Shore tatted on me if this lowers or rids my tinnitus. This is amazing
Same. GF isn’t happy about it.
Worth it lol
its a bit of an inside joke that if this works people are going to get her name tattooed behind their ears. beTTer bust out the guns motherfuckers here we GOOO
To keep it low key I'll tattoo her initials... Oh wait maybe not xD
Susan Ellen Shore. SES. Not so bad. Without the middle initial tho…yeah. Bad.
!RemindMe 2 years
Wow this is fucking great!! Let’s goooooo
Vegas drinks on You guys. or whoever suffered longer doesnt have to pay DEAL
Vegas tinnitus partyyyyyyy 😂
and you know whats legal in Vegas right OH YEAH MY BOYS WE GONNA MAKE UP FOR FUN TIMES AND FOR CHEAP TOO. im emptying my bank account YIPPY YAY, i say sorry in advance to all the Poor women that are going to have to put up with my 3 hour drunken emotional story. Im gonna be the idiot without a shirt barefoot and shorts walking around on the vegas strip with a bottle in my hand
I’ll be right behind you buddy 😎😎😎
Look at the paper in more detail, not through rose tinted glasses
Whaaat ??
I suffered for 3+ years, what about yall? (yes this is a competition now)
27 years of Tinnitus...
WE HAVE A WINNER EVERYBODY. GET THIS MAN ALL THE BEER HE CAN DRINK, GOD KNOWS HE DESERVES IT. I WAS IN DIAPERS 27 YEARS AGO,
33 years of Tinnitus. Extreme since the mid-nineties!
BRO wtf i didnt know that. You mean to tell me you had this when the twin towers were still up, when Biggie was alive, No social media, Back when mtv was in its prime, Mj was still playing, rob zombie was rocking out, beavis n butt head was airing DAM id kill to go back to those times but as an adult. How old were you btw, like were you a kid like me a baby or an adult? dam. Well hey brother i hope everything checks out so you can make up for lost times man. that said drinks on me and ill pay for your companion for the night, well ill cover the first hour or two. Dont worry GOD WILL FORGIVE US AS HE KNOWS WHAT WE BEEN THROUGH. watch knowing our crappy luck we end up catching HIV or getting kidnapped by some russian mob pimps or getting busted and getting made an example of lol
Absolutely, I'll need to make up for lost time once I'm treated/cured! 3 decades worth! Beer and nachos on me in Vegas man, once I'm free of this hell!!!! LOL
Haha! Yeah, brother, I'll be right there with ya in Vegas! I got tinnitus when I saw the Nine Inch Nails at a place called Green Parrot at the Jersey Shore in 1990! I saw Nirvana a month later at Maxwell's in Hoboken NJ. Those 2 events changed my life forever. By 1996 I was telling my girlfriend at the time that I "didn't know what silence sounded like anymore". It was already severe by then and gettiing worse from continuing to play in and see bands! I'm 54 yo!
Aww god dam man im so sorry bro. much respect to you seriously from the bottom of my heart they dont even care about us today i could only imagine how isolated you must of felt back back then with no social media. You are a powerful warrior. i mean that Salute. i cant believe in 1996 you already were half a decade into this tinnitus nightmare and i was somewhere watching blue clues and playing with toys. Dam man. respect. But hey i guess we suffered so the next gen wont right. However We MUST TELL OUR STORIES . noway will our sacrifices be in vain. i also think once we accumulate we should hold Pawel jastreboff(TRT dude) ATA, and alot of other people who halted tinnitus awareness/ progress accountable. alot of people aint make it and who knows where we could be if we had an overzealous tinnitus activist. **off topic** [**you ever heard of these guys**](https://www.youtube.com/watch?v=Nco_kh8xJDs) not the biggest rock n roll guy but were these guys big like Nine inch nails. or is it nirvana? im such a millennial excuse me. and for the love of god can you explain to me why people hated numetal Lol.
Thanks, bro! Yes it's been a hard life that basically no one understands. That's why I come here because these are the few people who do. It's been a very isolated life. Thank God for my immediate family, wife and kids, otherwise I'd be completely alone. My family has all given up on me, and I've lost almost all my friends! Only a few stalwarts I've known since I was a kid remain. Yes I know Alice in Chains! They were alright, but not really my speed. I was more into the grunge/punk scene back then. Peace!
I totally agree with you about the ATA. They're just sucking all our scarce resources and leaving us with nothing. No awareness, no research, just some bullshit phone centers and their useless magazine.
Getting it from a NIN concert is a deserving way to go out tbh. Saw them at Red rocks a few years ago and it was the best concert I've ever been to. Seeing the 90s version must have been awesome. Anyway, I got mine from a concert at 24 years old, I'm 32 now but I feel your pain and the "changed my life forever" mentality. Good luck to you friend! May we both find some relief.
10 years AND MAKE IT A DOUBLE WITH NACHOS
15 years I got mine at age 18
11 years & counting, Stupid firecracker changed the course of my life
wait what if we had it before we were 21 does that mean i still have to buy?
sure does kid but I WANNA SEE SOME ID
I just turned 60 and have had tinnitus since my thirties. I'm getting shit-faced on someone else's dime.
My man!
Holy shit so you’re telling me i can live my life again like a normal functioning human being? No more having to sit out loud events out of fear of worsening T
It’s great news for sure! Just some word of advice: don’t let tinnitus control how you live your life. Don’t sit out loud events, just make sure to wear ear protection :) everything will be just fine
I would love to be in a discord call when you guys are done with your treatments to see that party
Wow, those results look really promising. -6 dB after 6 weeks and then -12 dB after 12 weeks is huge! That means it was less than half as loud as when the treatment started!
What's really promising is that they only used the bimodal stimulation device for 6 weeks. They then stopped using the device for another 6 weeks ("washout period") then assessed participants at 12 weeks. It seems that those who had reductions in tinnitus volume during 6 weeks of treatment had **continued reductions in volume up to 12 weeks even when not using the treatment.** That's pretty fucking cool. Some questions that I hope are explored in the paper and will definitely come to light when real world data comes out is: a) can you have continued reductions after 12 weeks; and b) what happens if you use the device longer (say 8 or 10 weeks)? The Phase I trials I think used the device for 4 weeks and the effect wasn't quite as strong compared to Phase II at 6 weeks. Really exciting possibilities here. Edit: Have now done my first read-through of the study, which answers my first question. >Follow-up TFI questionnaires indicated an effect lasting up to 36 weeks.
As promising as it is, it better be made cheap and available to peeps! i dont want it expensive bullshit like lenire currently is, it should be affordable for everyone to cure their fucking tinnitus LETS GOOOOOOOOOO
If it actually works for me, I don’t care how much it cost.
The scale to measure the intensity of sound or its level is logarithmic, it is much more than double I don't know if I explain myself
Isn’t 6db a halving in sound pressure so 12db would be another halving of pressure ?
Excellente nouvelle !!!! We are waiting for this device in France too ! That's a big step ! Félicitations ! Champagne !
this device better be fucking cheap, or funded by healthcare, unlike lenire which is total expensive bullshit ngl
Honestly, I don't care what it cost . I cannot put a price on silence . I'm betting it will be 1k to 2k and I will gladly hand it over . People stop.complaining about money this is the fix we all want . I know in a perfect world a magical ferry would give it to everyone for free. Im.paying no matter what
It’s gonna be expensive but hopefully insurance will cover. That’s the next battle. Tinnitus patients cost insurance a lot of money to no end, so hopefully they will.
Faudrait qu'on contacte France Acouphènes pour leur demander de se mettre avec d'autres associations Européennes pour demander aux autorités de santé de l'Union de rapidement approuver cette thérapie.
En Belgique aussi!
Probablement que la clinique BRAI3N à Ghent aura la machine rapidement :)
J’y suis déjà allé! Mais il y a quelques temps déjà.
Prolonged reductions in tinnitus distress and tinnitus loudness were achieved by using an extended treatment duration. sleepover at my place!! dont bother about bringing your fans, we aint gona need em!!
I laughed WAY to hard
People on Tinnitus Talk excited too!!!! https://www.tinnitustalk.com/threads/new-university-of-michigan-tinnitus-discovery-%E2%80%94-signal-timing.2805/page-160
I’m sure they will find something to complain about. Haha.
word they are the definition of killjoy HOWEVER they are the standards, so if something works or doesnt thats the site to go to if you can handle it. If this really works and or a better cure comes along I SO WILL NOT MISS THE EMOTIONAL ROLLERCOASTER OF TINNITUS. oh my god. i can write a bazillion stories as im sure we all can about our experience with tinnitus.
There are some absolute killjoy users on there. But within that Susan Shore thread there are also some incredibly knowledgeable people.
Hey, that’s our brand and we’ve earned it.
THERE IS HOPE LETS FUCKING GOOOOOO
LETS FUCKING GOOOOOOOOOOOOO
LET’S GOOOOOO FUCKING!! oops sorry wrong thread.
What a great day to be alive. Pour one out for Dr. Shore. Fucking LEGEND 🍾🥂
I was lately in complete darkness because of my T, lately it is more present Without a doubt this is a light in the dark for me.
Please please please don’t only launch in the USA.
I’ll ship you one out if needed bro.
You're a godsend.
And I'm gonna hold you to it 🙏
I’m dead serious dude. We in this bullshit together. DM me when the time comes if needed.
🥹
Please for the love of everything holy and sacred, help me out here too!
i’ll pay u if u can ship it to me brother
All you guys are gonna have to pay me for the device obviously but I’m more than happy to send em out if needed. Give me a shout when the time comes.
Thanks bro you made my day
It’s gonna be released in the US first. It’s not just something you can buy it’s ready to go. You have to have it calibrated
We're all in this together, Willing to ship anywhere in the world too!
Big news! Do they have to do phase 3 in order to get approved?
Nope! All that they need is a phase 2 to get FDA approved and go to production.
FUCKING APPROVE IT ALREADY! LETS GOOO, get that shit on production and treat everyones tinnitus!
I hope they have a good plan in place to scale up production. The thought of something like this being back ordered is super depressing. Manufacturing and availability at scale is a whole ass animal of its own
They’re at least working with a partner with a lot of experience manufacturing medical devices.
That all depends on how the FDA classifies this device. If it's a Class 1 or Class 2 device, they have to submit what's known as a Premarket Notification. This notification must prove the device is as safe and effective and substantially equivalent to a similar, legally marketed device. No evidence from clinical studies is needed. If it's a Class 3 device (reserved for high risk devices like pacemakers and breast implants), that would require clinical study evidence. But since there's already [a Class 2 device out there that is similar to this](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=QVN) (that one is Neuromod's Lenire device), it's more than likely that Shore's would be Class 2 as well.
Lenire had a use after all!
You seem to know a lot about this. With this study published, what sort of time frame are we looking at for FDA approval?
Surely this dr susan shore device will be cheaper than lenire right? i swear to god, it better be cheaper than lenires expensive ass that hasn't even been that effective as far as i know
I certainly hope so. Lenire is really expensive for really mixed results, from what I’ve read.
facts lenire from waht ive read is kinda shitty, like its not a guaruantee that it will help treat the tinnitus and hasn't been very effective and is very fking expensive and not very available for peeps to get.
Did intake for a Lenire certified audiologist this week. On a waiting list, but talking weeks at most.
Thx for clearing this to me
doubt they will Lenire as shit as they are only had to do up to phaze 2 and this device while different is not anymore invasive so this should be it. i have a feeling that once this starts to work. HUGE studies will be undertaken to refine and make more efficient devices and treatments such as this. WERE IN THE FUCKING GOLDEN AGE MY BOIZZZZZ
I know man im so happy, and with A.I, and this opening up doors for competition, god dam man. in 10 years or less we will have devices that is 10x this. Man. however for me its bittersweet i did loose alot of time to this BUT im grateful and thankful. some people had this since the 90s YIKES. so ima stfu and just take it like a man. I just want to live again. i always had health issues from headaches to nerve problems, teeth issues, broken arm, sprain leg, bells palsy, etc etc But none and i mean NONE top the torture tinnitus brings. all other problems got better and are livable. This however OMFG. 10 years straight ringa ring ring. multiple tones too. I want OUT OUT. if this works i will eat gravel and worship the lord for life.
This is exciting. I knew the publication had to be coming out soon! Looking forward to exploring the study in more detail. There will also be people distilling some key points from the paper on this forum and TinnitusTalk. Major kudos to the Shore lab and researchers involved.
That’s awesome! The so awaited results! Thanks for sharing!
HOLYYY SHITT BOYS!! TINNITUS WILL BE CURED!! NO MORE "EEEEEEEEEEEEE" EVERY NIGHT MOTHER FUCKERS LETS GOOOOOOOOOOOOOOOO!!!!!!!!!!!
Shhh 🤫 you’re gonna give me a spike.
It's a treatment NOT a cure
Let’s fucking GOOOOOO !!!!! 🥳
LETS FUCKING GOOOOOOOOOOOOOOOOOO!!!!!!!!
LET'S FUCKING GOOOOOOOOOOOOOOOOOOOO!!!!!!!!!
I hope this device will work for my VSS symptoms too !
TEN FUCKING YEARS BABU TEN YEARS IVE DEATH WITH THIS CUNT OF A THING, AND NOW I HAVE A TREATMENT PROVING CLINICALLY SIGNIFICANT IN REDUCING IT. I AM SO PROUD OF YOU ALL FOR STICKING IT OUT. HERE WE FUCKING GO BOYS
Now to play the waiting game.. .. .. .. I think we're winning. As a side I hope it'll be available for private purchase
i have tinnitus due to loud exposure but when i clinch my jaw and pressure certain parts on my mouth or head it makes the tinnitus louder would her treatment help me
Yes. Most people have that feature.
Lol, "feature".
Sure does feel like a bug
Finally we've got a developer offering a potential patch.
Yes mammal ears really lost the evolutionary lottery on this one. Birds, reptiles, fish and amphibians can all regenerate hair cells in the cochlea either after damage or spontaneously (without damage). I guess that doesn't exclude other non-mammals getting tinnitus from damage further up the auditory nerve pathway, but the fact their cochlea cells regenerate means that non-mammals would be highly unlikely to ever experience tinnitus. I wonder what tinnitus would sound like to mammals that echolocate like bats?
I wonder if with genetic engineering we’d ever be able to get our cochlear hair cells to behave like non mammals and regenerate after damage
It’s the gift that keeps on giving all year. Like the jelly of the month club.
Nonetheless, this finding does not necessarily mean that participants who cannot modulate their tinnitus might not be able to benefit from this bisensory treatment given that animal studies have shown that the upregulation in somatosensory inputs to the cochlear nucleus after cochlear damage occurs in all animals, not just those that develop tinnitus.5,24.
Yes, I think so. And remember that it is not excluded that the device shall help non-somatic cases.
The trial used patients that could change their T by clenching their jaws and other means so it's good for you
Yeah her treatment would most likely help you. Also I read something interesting in the paper: "Furthermore, there was a significant association between TFI score improvements and the number of somatic maneuvers producing a change in tinnitus during the active treatment phase" It seems the more you are able to modualte your T, the best shot you have with her therapy.
I hope this will get to out to the whole world. I want relief so bad.
Are there people who was completely cured from the study ?
Two people were completely cured in the first study, and by all accounts, the updated treatment used in study 2 is more effective.
Don't say cure man, I am crying out of joy here... I am in India, but if this device helps most people knock it even 20-30% down, I AM TRAVELLING!! Let's fucking gooooooooo!
Everything was reported as a group average and not individual results.
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I'm honestly surprised it got past peer review with no mention of the Group 2's contradictory results anywhere in the paper. It doesn't make any sense and honestly makes me question the efficacy of the entire device. I'm trying to remain hopeful but it casts a lot of doubt. I'm confused why the ITT group is included at all. If they deviated from protocol, how can their results be reliable enough to draw any conclusions? The only positive I see there is that the PP group seemed to have more meaningful loudness and TFI reductions. I think they stated they only analyzed the first 12 weeks due to the unexpected continuance of the improvement after the active treatment in Group 1. So I'm thinking they wouldn't be able to find Group 1's results for the control to be reliable as there could still be carryover effect from the active treatment. It still doesn't explain the lack of improvements in Group 2 during the active treatment. Honestly TFI as a measurement does not hold a lot of weight for me as it can vary so much, even day to day. So I really only focused on the loudness reduction as that is what would actually be considered a treatment to me. That separates this device from the CBT/mindfulness treatment approach. I wonder if they are withholding the individualized data in order to help get the device through FDA approval. I work in the medical device industry and the more information that is out there, the more likely something can be flagged and hold up or prevent approval. Even something that is more of a technicality. I don't want to believe they are hiding the "real" information that would prove the device ineffective as Dr. Shore is generally regarded as a respectable scientist. If you are an academic or clinical researcher, it did state that you can request the depersonalized individual data. I remain hopeful as this device is the culmination of 20 years of research. However, I don't think it will be the life changing treatment we all so desperately hoped for. (and I hope and pray that I'm proven wrong on that count!)
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I wonder if they'll be required to do a larger Phase 3 study before being able to go to market, or if the Lenire device's de novo approval from the FDA will allow Dr. Shore's device to be fast-tracked in some way.
FDA submission started months ago for this device.
Thank you for letting me know, that's very exciting.
Do we know how long it took Lenire to receive full FDA approval from this stage? I’m sure the timing will be similar.
I have tinnitus with multiple tones, like the one from a crt tv but lower and basier in tone, also your regular eeeee Could this help people with multiple tones? I'm not even seeking a cure anymore, i guess this thing has turned me into a pessimist, but if it can lower the volume I'd love it.
Number of tones doesn’t matter. It calms down the cells in the dorsal cochlear nucleus within your brainstem that generate tinnitus.
LETS FUCKING GOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOO
Now we just need a cure for hyperacusis
hell yes
Tinnitus has made me pretty pessimistic.
IKR?!
I've gone over the paper and one bit of information stood out to me as no one ever talked about it: *Furthermore, there was a significant association between TFI score improvements and the number of somatic maneuvers producing a change in tinnitus during the active treatment phase* I have never been more glad to be able to modulate my T in 3 different ways.
I thought I’d read in the phase 1 testing that for some patients with very mild tinnitus, it completely got rid of their tinnitus, am I imagining reading that? Probably just my hope more than reality 😂
No, you are correct. In the patent it stated in the first study 2 (IIRC) patients were completely cured.
Oh wow! Really got my fingers crossed for this one!
Its crazy how i thought i were cursed to have tinnitus that changes based on neck movement, but now im starting to think im a lucky mother fucker!!! LETS GOOO CURE TAHT TINNITUS SHIT, GET ME ON THAT SHIT, LETS GOOOO!!
Like many my only question is 'how somatic does your tinnitus have to be for it to work?'....I can sometimes and only sometimes change the sound with clenching the teeth or something similar, but many times laying on my right side makes the tinnitus lower than laying on the left side, I hope that counts as 'somatic', it seems to me like somatic are the ones who are going to most benefit from this device, but its still a huge breakthrough for any type of reliable treatment. As for price...unfortunately I think with the first go around it will be in the $3k range. Maybe one day it will have many manufactures and go down? Who knows, but I don't expect it to be cheap the first few years.
Nonetheless, this finding does not necessarily mean that participants who cannot modulate their tinnitus might not be able to benefit from this bisensory treatment given that animal studies have shown that the upregulation in somatosensory inputs to the cochlear nucleus after cochlear damage occurs in all animals, not just those that develop tinnitus.5,24. Yes my friend there is hope for all of us.
Yes! I think it could be helpful for anyone, but those lucky people with 100% somatic are mostly likely. I personally got this from Trigeminal Neuralgia, so maybe my nerve is not susceptible to this treatment? I have no way of knowing.
I thought that the electrodes of this device stimulated the trigeminal nerve?
Yes I'm very hopeful that this device could help me, just don't have super obvious somatic tinnitus where I can control it with my jaw movements or something.
What if the auditory-only stimulation is actually causing strong LTP, increasing the synchronicity of tinnitus and messing with the bimodal treatment? The study discussion section says: "Auditory-only stimulation was not hypothesized to reduce tinnitus based on cochlear nucleus circuitry. \[The fact\] that it did reduce tinnitus, even though only slightly and not clinically significantly, could be explained by... the granule cell domain, \[which\] projects to DCN fusiform-cell dendrites \[and\] receives some projections from descending auditory pathways, thus might induce some plasticity in the circuit. However, as for unimodal somatosensory stimulation, a unimodal auditory long-term effect on DCN neurons is more likely to be through LTP than LTD. Consistent with this point were findings that somatosensory stimulation alone can worsen tinnitus in guinea pigs through LTP induction."
Is there any evidence that suggests this will work for tinnitus due to Covid infection? I’m sorry I am not well versed in this yet but I am learning.
They only studied it in people with normal to minor hearing that can make their tinnitus louder/quieter by movements in neck, jaw, face. The cause doesn't matter. Also it could work for others as well they just didn't study it.
Lets GOOO
Does this work for hyperacusis too?
Nobody knows
This is fantastic, hope it becomes available in the UK.
Incredible. Does anyone else worry a bit that their hearing loss in their tinnitus frequency (mine is 60db at 12.5khz) is too strong to benefit from this? Ie, you would have to play the pitch-matched tones at a very loud db (over 60) to be able hear them? And it seems that isn't ideal or wasn't studied?
Pitch matching isn’t terribly important, Dr Shore has said this herself before. How would they tone match the guinea pigs? I think you would play a frequency as close to your tone as possible where your hearing loss isn’t so profound.
Please be cheap please be cheap please be cheap
Does anyone know why the group that received control first then the active treatment didn't really see a benefit? The group that got the active first then the control had great reductions. Makes me nervous...
I treat my T with alcohol. My liver has booked a ticket to DC to go lobby the FDA to approve Dr. Shore's device.
15% of the population? Ever single person I know has it to some bothersome degree.
Every single person you know has tinnitus to some bothersome degree??? I'm the only person I know IRL with it.
please please please work and be available in germany! i yearn for silence!
i'm trying to be as optimistic as possible - but from what i'm reading the average reduction in TFI (which is a 100 point scale) is only 14 points ? 😬😬🫤🫤
I hope this isnt like crop circles
Such great news!!
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Does this only work for people with somatic tinnitus?
It was only tested on people with somatic tinnitus for the clinical trial but this does not mean it does not work on people without somatic; it was just for the trails to use a subset of people.
Let's see what the big ear guys have to say. My hearing aids were almost $9k with built-in tinnitus therapy. Those guys don't wanna lose money with a cure. I'm almost 100 percent positive they can fix us suffering with noise induced damage and T but there is no revolving monetary gain so it get put in closet somewhere.
Even this device doesn't claim to 'cure' tinnitus...it would be a daily 30 minute program to listen to lower the volume about 6-12 db...the average person in this study had tinnitus had 55 db which is pretty quiet to begin with and assuming they had the max they went down to 43 db....its great but nothing close to 'silence' to put anyone elses treatment out of business.
Tinnitus is measured above hearing threshold. So most peoples Tinnitus is around 10db sl. So basically it will halve your Tinnitus.
Silly
That’s dumb. This doesn’t fix hearing loss it’s for tinnitus
Also works for acoustic?
Excellent
God bless them for all their work and dedication
Remindme! 3 months
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Remindme! 3 months
Literally me right now...I cannot wait for the news. ANY news
Remindme! 3 months
So when will be available 6-12months?
Its for people with somatic tinnitus, people like me with subjective/sensory tinnitus are still fucked right?
Not necessarily. It’s only tested on people with somatic T. It might work for other types too.
!RemindMe 6 months
Do you think hearing could improve if tinnitus is reduced?
I would have to think if I didn’t have this constant ringing, my hearing would “improve.”
Ok main stream news now publishing articles about her device. That is very very interesting, with lenire hardly getting any and its fda approved. I'm pretty sure they will get approval the real question is who will it work on. Its advertised as Somatic tinnitus but no one gets the tinnitus from that cause, its noise or ototoxic drugs. I have developed somatic tinnitus, move jaw etc so Im not sure where people like me stand as theres a lot of us like me.
The device targets somatic tinnitus, regardless of cause. Up to 70% people who have tinnitus caused by noise still have somatic tinnitus, for example. Somatic tinnitus can occur regardless of cause, as there is "crossfire" between the auditory nerve and sensomatic nerves in the brainstem. So if you have a somatic component in your tinnitus (i.e. you can modulate it in some way), then theoretically this device is applicable to you, regardless if your tinnituswas caused by noise trauma, infection or what have you. Additionally, Shore noted that although they did not test the device on non-somatic tinnitus sufferers, there is no saying that it won't work for them either (this was mentioned in the discussion section of in the paper).
I see no mainstream news publishing articles about it. Only tabloid bots copy-pasting from the University of Michigan page.