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I have a similar experience with my secondary endolymphatic hydrops. I have to follow a low-salt, low-sugar diet, and I take prednisone when it flares up. I’m hopeful that the new drug, SPI-1005, will help if it gets approved.

We would be in the exact same place we are now. Unfortunately.

Did an acoustic trauma cause your tinnitus? I have secondary Endolymphatic Hydrops caused by an acoustic trauma.

Maybe listening to sound stimulation at the same frequency as their tinnitus reduced their tinnitus level. When they added electrical pulses, it had an even greater effect.

Hopefully, increased hearing would turn down the brain's central gain and reduce hyperacusis. My tinnitus sucks, but my hyperacusis is horrible.

Correct. Maybe a couple of hours. I didn’t really pay much attention to when the Lidocaine wore off at the time.

My tinnitus spiked with each episode of sudden hearing loss in the left ear. The hearing loss recovered and tinnitus calmed back down each time. It happened 3 times in the last year and I got 3 injections 1 week apart each time. I was also put on high dose Prednisone each time. I think the key...

I had 10 intratympanic injections of Dexamethasome in my left ear over the last year, for sudden hearing loss due to Meniere's. Each time they also gave me a couple shots of Lidocaine inside the ear canal about halfway in to numb it before the intratympanic injection. Sometimes they would give...

I got tinnitus and hypercusis 5 years ago. 4 months after my twin boys were born. I keep a pair of earmuffs handy!

Unfortunately after 20 years of research, no one knows the answer to this question. We probably won’t know anytime soon either.

The wait continues with no end in sight.

It’s disheartening knowing there is finally something that seems like it will help many of us sitting on a shelf collecting dust. I hope we don’t have to endure this same conversation for the next two or who knows how many years before we are able to get some real world feedback on this device.

I believe Dr. Shore has been working on this research for close to 20 years now.

I sure wish someone would light a fire under Dr Shore’s arse! Gotta be the slowest development for treatment in the history of mankind!

Does Dr. Shore own the rights to her research for this device as it was done at UofM? Would the UofM own any rights to this research or device? Could this be a cause of delay if it is true that FDA approval submission has not started? I’m not familiar how intellectual property works while...

I think you are spot on. I also can’t overlook the worsenings reported in the study.

I damaged my ears with loud music 4 years ago. I felt the same way you do. I had terrible guilt. Please give it some time to heal. My hypercusis got much better. Here are some things that helped me to overcome the mental side of things: Just focus on one day at a time. Don’t futurize your...

Just think... In another five, maybe ten years, we won’t have to guess how effective this device will be. :) :whistle: (y) J/K. I enjoy checking this thread daily as a distraction to the maddening sound within my head. Hopefully we see FDA approval soon and have access to the long awaited...

I wouldn’t read too much into the exclusion criteria. Studies are aimed for approval and designed to eliminate as many variables as possible to aim for consistency. I think the device has helped to treat both tinnitus and hyperacusis.

SPI-1005 is taken orally as a pill.

It seems Auricle will be a superior device to Lenire, but Neuromod seems light-years ahead as an established company vs. Auricle.

Does anyone have an appointment at one of the US clinics yet? The Lenire website says availability will begin in April.

I would take dependency on this device in a heartbeat if it helps.

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

Kinda reminds me of the saying, the beatings will continue until morale improves!

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

I woke up with muffled hearing in my left ear. My hearing seemed like I was wearing an earplug in my left ear vs. no earplug in my right ear. It was very noticeable. I went to the ENT within 4 days and took a hearing test which showed a small drop at 2000 Hz and large drops (30-40 dB) at 6000 Hz...

Sounds promising. I sure hope we have something next year.

Keep The Faith - Bon Jovi

Staying positive for continued healing for everyone in this community. Prayers and well wishes for all to improve.

May we all find relief and happiness and live our best lives. Amen!

I sure hope Dr Shore has good news for us! FX 345 success would be a blessing as well!

I’ve had tinnitus for 4 years from an acoustical trauma. I had sudden hearing loss in the higher frequencies of my left ear one week ago. I got an intratympanic injection of Dexamethasone in my left ear 4 days later and started on Prednisone 60 mg x 5 day, 40 mg x 5 days, 20 mg x 5 days, 10...

Did your spike go down after you stopped taking Prednisone?

Did you have hearing loss or tinnitus prior to the itch/muffled hearing? I’ve had tinnitus for four years from an acoustic trauma and woke up three days ago with muffled hearing in my left ear and increased tinnitus in that ear. I have an appointment with an ENT tomorrow morning. We’ll see what...

Susan Shore has a bunch of patents in place to hopefully prevent this scenario being a hold up.

I’m calling BS on that excuse. Why did Dr. Shore release data on the preliminary trial of 20 people if that would risk regulatory filing/FDA approval? Why did Lenire release papers with results of their multiple trials, but are now in the process of obtaining FDA approval? Lenire is going to be...

Thank you for sharing this with us Deb.

I believe Dr. Dolittle helped with the animal models.

Let’s face it. We aren’t going to know anything until at least the end of next year. Results must not be that spectacular or she would be pushing a little faster to cash in. I have been a big believer in Dr. Shore’s work, but at this point she is turning into a joke...

1. Dr. Susan Shore's device. 2. OTO-313 Bezos money could get access to either of those today.

I have a decibel app on my phone and the loudest bark measured about 105 dB. They have a deep bark which doesn’t bother my ears as much as the high pitched yappers. Luckily my dogs don’t bark much.

The Dems are gonna get slaughtered in November and it’s not just because of Biden’s record inflation.

Maybe Biden should quit handing out trillions of dollars of free money. Ya think that has anything to do with this record inflation?

Yes. This is from the paper: “Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud...

I would take a hard kick square to my nuts if it got rid of my tinnitus!

I believe so.

The sample size (number of people in the trial) will have no effect on if this device will work or not. They are testing the device at one location in a University setting with a limited budget so a small trial size means nothing to me, good or bad. Even with the small trial it is taking an...

Lenire and Auricle are both neuromodulation. That is correct. However, their approaches with regards to stimulation and timings are completely different.

I think Lenire does help some people. Maybe 15-20% of people who try it. I think Lenire is more likely to help people that aren’t as severely distressed as most of us on Tinnitus Talk. Maybe that’s why we don’t see very much positive success of it on this site. Lenire is more of a habituation...

I haven’t let tinnitus stop my career. I have a family to take care of so I had no choice but to keep on keeping on.

That is only my best assumption. I don’t see why Dr. Shore would already be forming her own company Auricle if her device didn’t work or they were still trying to figure out if it works.

That’s an easy one. Capitalism! It’s maddening to think there is an effective treatment that already exists but we won’t see anything for another 2-3 years at the earliest. Just sit around and suffer because of bureaucratic BS. I have the money to burn and am willing to assume all risks.

My gut says we are realistically still 2-3 years away. I wish someone like Elon Musk would buy the technology. Then I would say probably 1 year away. Dr. Shore has been working on this going on 20 years and still doesn’t have a completed trial. I see no reason why things will all of a sudden...

12 kHz according to this graphic.

I think we will see better results across the board from Auricle's device.

Hopefully Lenire has already applied for FDA clearance and is approved by mid 2022. Maybe that would significantly speed up the approval of Auricle.

I believe the first approach is how Shore’s device works. It’s in all reality 1-3 years before available for consumers.