I Haven't Been in Here for 2 Years — Any Updates?

My first 2 months being a 15 year old with tinnitus was rough, but lowkey I got over it. And even nowadays I wear earbuds without much care (although I do make it quiet).

Since those 2 years, any big updates I should know about research towards tinnitus? Is there gonna be a cure anytime soon?

 

Recent developments

• Frequency Therapeutics - hearing loss regeneration
  • completed phase 1
  • phase 1/2 to begin this year and phase 2 next year
• New device against tinnitus by the University of Michigan (Susan Shore)
  • phase 2 expected to begin in autumn
• Xenon pharma
  • expected to begin phase 2 by the end of 2018 (medication primarily for epilepsy)
• Otonomy
  • several phase 1/2 trials planned to begin in 2019

Companies

Spoiler

Hair Cell Regeneration

• Frequency Therapeutics - FX-322
• Otonomy - OTO-6XX
• Audion - Regain
• Genvec / Novartis
• Hough Ear Institute
• Columbia University Medical Center
• Harvard University
• Stanford University
• University of Southern California
• ...

Repairing Synaptic Damage (Hidden Hearing Loss)

• Affichem - AF-243
• Otonomy - OTO-413
• Hough Ear Institute
• Bionics Institute and University of Melbourne
• Decibel Therapeutics ?
• USC and Harvard
• ...

Acute Hearing Loss

• Soundpharmaceuticals - SPI-1005 (NIHL, mild - moderate)
• Sensorion - SENS-401 (SSNHL)

NMDA receptor antagonist

• Otonomy - OTO-313 (probably for acute tinnitus; not yet specified)
• Esketamine (brand name: ketanes; for TRD)
  • phase 3 completed nov 2017

Potassium channel opener

• Xenon Pharma - XEN-1101a (new retigabine, for epilepsy)
• Autifony - AUT00063, Kv3.1

MDMA

• Maps - two Phase 3 clinical trials of MDMA-assisted psychotherapy in patients with severe PTSD starting in 2018

Devices

• University of Michigan
• MuteButton / Neuromod
• Serenity System
• University of Minnesota
• Signia Notch Therapy (Hearing Aids)

Others

• Roche (Inception3)
• Sound Pharmaceuticals
• Quark Pharmaceuticals
• Otologic Pharmaceuticals
• Acousia
• O-Ray Pharma
• Oricula-tx
• University Medical Center Groningen(implant; Estimated Study Completion Date: January 2022)

Trials

Spoiler

Hair Cell Regeneration Trials in 2018

• Frequency Therapeutics - FX-322
  • Phase 1/2 (begin 2nd half of 2018)
  • Phase 2 (begin 2019)
• Audion / Regain Trial
  • Phase 1/2 ongoing in UK
• Genvec / Novartis - CGF166
  • Phase 1/2 ongoing

Other Trials in 2018

• Xenon Pharma - XEN-1101 (new retigabine / for epilepsy)
  • Phase 1b ongoing in London
  • Phase 1b completion date: July 2018
  • Phase 1 results: 2H2018
  • Phase 2 expected to begin by the end of 2018
• University of Michigan
  • signal timing device (Pivotal study / Phase 2 begin: August)
• MuteButton Device // Neuromod
  • trials in Ireland and Germany; more trials in the US planned
• Sens-401
  • Phase 2 (for SSNHL)
• MDMA
  • Maps - two Phase 3 clinical trials of MDMA-assisted psychotherapy in patients with severe PTSD starting in 2018

Trials to begin in 2019

• Frequency Therapeutics
  • Proper Phase 2 (?)

• Otonomy
  • 1H19: OTO-313 (reduce tinnitus) Phase 1/2
  • 1H19: OTO-413 (repairing synaptic damage) Phase 1/2
  • OTO-6XX (hair cell regeneration)
    • 2H18: candidate selection
    • 2019: Phase 1/2

I personally don't expect a treatment for the next five years... I'm hopeful that someone might bring something onto the market within the next ... 7-10 years. But that's just my personal opinion, maybe Susan Shore's device might be available sooner.

 

Had tinnitus as a sophomore in high school. Now I'm a sophomore in college. I haven't checked Tinnitus Talk since May 2018 and I asked the same thing, seemed that we were getting close to treatment. Now over a year has passed, and I'm wondering if there's any good news.

 

Yes. There is anecdotal evidence from the Regain trials that hair cell regeneration treats tinnitus and hyperacusis. FX-322, which is based on the same technology is entering phase 2 and has been granted fast track status by the FDA. Neuromod looks like a dud. Susan Shore BTFO'd Neuromod in one sentence. A representative from the Hough Ear Institute came here and claimed they have a pill that treats tinnitus but it seems like it is all tied up in trial shit and funding problems. There's more but, meh.

I myself traveled to South Korea to a clinic that uses bone marrow and PRP to treat hearing loss and it seemed to have helped, no cure though.

I also have direct knowledge that an experimental drug combination of NT-3 and BDNF is safe for human use and one of these compounds, BDNF, is safe for human use although it is currently entering safety trials which will take at least a year to verify something I already know.

 

The first device for chronic tinnitus based on bimodal neurostimulation was launched in Dublin, Ireland. The device is called Lenire, the company is called Neuromod.

• their homepage
• Lenire thread here on TinnitusTalk
• User Experience thread on TinnitusTalk

 

Check out this thread. It's the reviews of Neuromod Lenire, the just released device to treat tinnitus using bimodal neuromodulation. So far some have had great help, others not quite as much. Most seem to have an initial worsening, then start getting better, so it clearly is doing something, but none of our users have yet finished the treatment so hopefully we hear even better feedback soon. The companys' statistical claims are pretty good, so if they are true, time will let us know.

 

I dont expect a treatment at all, considering the zero progress in the last 50 years.

 

Lenire has already shown some positive results as has the Susan Shore thing.

 

Me neither.

 

what are you 2 babbling about? there has been progress. you're basically lying.

 

Lying? I meant that I don't expect a treatment at all in my lifetime. How is that lying?

 

Sorry, I was asserting the claim that there hasn't been any progress is a lie and directing my comment to your comment chain.

 

OK, no problem.

I don't mean to sound negative and I understand that there's a lot more research now than 20 years ago, but I just don't expect to ever be cured. I'd be happy if I were proven wrong, though.

 

I don't think there will a 100% cure for all types of tinnitus anytime within the decade, however, I do believe that there will be several treatments that will in fact lower the volume, lower hyperacusis, and improve hearing.

A trial participant from the Regain trial spilled the beans and stated their hair cell regeneration improved his tinnitus and hyperacusis.

Just think about it in simple terms. The hair cell is the one thing that doesn't heal on it's own. They can now regenerate the hair cell. The main issue now is delivery, and to reiterate the Regain patient, it can in fact permeate the round window and have an effect.

 

Me neither.

 

I agree, but something to reduce it will be there.
Mild tinnitus is almost like no illness.
Severe tinnitus is like the worst illness.

What a condition!

 

I hope you're right.

 

Please elaborate on this...I go to Seoul all the time for work....and now “conveniently” my worse tinnitus gives another reason to go. I’m only there for a day at a time though....what do they do with bone marrow and what is PRP? Thanks.

 

Bump! Now I’m about to be a junior in college.

 

Frequency Therapeutics showed promising results in their FX-322 (hair cell regeneration) phase 1/2 trial with a few participants gaining large word score improvements and 10 dB increases at 8 kHz on their audiograms. There is anecdotal evidence that some patients reported a decrease in their tinnitus. They are now on phase 2a trials with results to include audiograms up to 16 kHz to check for hidden hearing loss and THI scores to quantify tinnitus. Results will be available mid summer next year.

Lenire seems like it is mostly a dud, however bimodal neuromodulation can probably still be improved upon and eventually provide tinnitus relief. There is at least one person here whose tinnitus became non-existent after using a similar neuromodulation device by another university.

Otonomy is working on drugs to cure:

• OTO-313 - Tinnitus. Finished phase 1/2 with results that 57% of the drug group had improved tinnitus. However, there is also someone here who was in the trial and got worse tinnitus and this drug seems mainly for acute tinnitus (less than 6 months?), although it could work for severe.
• OTO-413 - Synaptopathy. Drug used to regenerate/repair ribbon synapses, which helps hearing loss (word-in-noise scores) and could also help with tinnitus. Finishing phase 1/2 and will have results in September.
• OTO-6XX - Hair cells. Like FX-322 but still in very early stages. Aims to regenerate hair cells.

Hough Ear Institute pill is still collecting funds for their drug study. Hard to tell what's going on with them anymore. Nothing yet to show for. Also think it will only work in acute stages.

Gateway Biotechnology is creating drugs to combat hearing loss and tinnitus. GW-201, Tetrandrine, is specifically for tinnitus. Although this may also only work in acute stages.

Pipeline Therapeutics is creating drugs for hearing loss. PIPE-505 just started their phase 1/2a trial for synaptopathy. I personally like the kinds of information they are going to gather from this trial.

XEN-1101 is in phase 2b with results expected in mid 2021. Not sure if this is a reformulation of Trobalt (which helped some people with tinnitus) or something that works similarly, but I think it's supposed to be more potent/effective with a better side effect profile.

Professor Thanos Tzounopoulos is still working on his tinnitus drug RL-81, which may eventually be seen in the next decade. It's supposedly 15 times more potent than Trobalt with a much improved side effect profile.

Elon Musk's Neuralink may be a cure for tinnitus, while allowing you to turn off your lights with your brain. Similar to DBS. This could be available sometime in the next decade or so, if brain implants are your thing. New press release this Friday, August the 28th.

There are some other things, but these are the ones I found interesting. I'd say check back in mid 2021 and there should be more results.

 

Try again after you get your PhD, we might have something