Any Progress for a Cure in the USA?

[Tammy Rowe]

Is there anyone who knows if they're doing anything for tinnitus in the USA? Any breakthrough testing in final phases for a cure to hit the public?

 

[threefirefour]

Is there anyone who knows if there doing anything for tinnitus in the USA? Any breakthrough testing in final phases for a cure to hit the public?

Good question, and there's a lot of perspectives.

What do you want exactly? A cure as in "absolutely no tinnitus"? And by final phases do you mean "in the FDA pipeline"?

Today, AM-111, something that was supposed to repair hearing loss, failed. So on the complete cure front, we won't be seeing anything for the next 5-7 years most likely.

On the treatment front, The soonest one to my knowledge is Signal timing reduces tinnitus by a lot, and it's entering it's pivotal stage. Meaning there's one more trial, but it's a device and device trials are much quicker. We can realistically expect it to be on the market by or in 2020. It only works for people with somatosensory tinnitus though.

So there will most likely be something soon, but no smoking guns yet. Sorry.

 

[Tempest]

I don't want to be mean, but you could have spent a few more minutes on this forum to find your answer.

 

[Tammy Rowe]

Ok what do you mean by spent more time to find my answer? Why not just ask those who may know something? I am new to tinnitus and all I see is Germany and the Netherlands doing anything just wanted to see if there is progress being made where I live.

 

[Autumnly]

Have posted this before, so sorry to anyone that's a bit annoyed by me posting this again… still wanted it to share it though. Not everything I've listed is based in the US but I'd say if, for example, a European company found the cure for hearing loss it would eventually also hit the US market.

Trials

Spoiler

Hair Cell Regeneration Trials in 2018

• Frequency Therapeutics - FX-322
  • Phase 2 (begin 2nd half of 2018)
• Genvec / Novartis - CFG166
  • Phase 1/2
• Audion / Regain Trial
  • Phase 1/2 ongoing in the UK

Other Trials in 2018

• Xenon Pharma - XEN-1101 - Phase 1 - (new retigabine / for epilepsy)
  • Phase 1b ongoing in London
  • Phase 2 by end of 2018
• Sens-401
  • Phase 2 (for SSNHL)
• University of Michigan
  • signal timing device (Pivotal study / Phase 2 begin autumn)
• MuteButton Device // Neuromod
  • trials in Ireland and Germany; more trials in the US planned

Trials to begin in 2019

• Otonomy - OTO-313 (reduce tinnitus) Phase 1/2
• Otonomy - OTO-413 (repairing synaptic damage) Phase 1/2
• Otonomy - OTO-6XX (hair cell regeneration) Phase 1/2

These are all the trials I'm currently aware of. More trials will most likely be announced in the upcoming years.

Companies

Spoiler

Hair Cell Regeneration

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

Repairing Synaptic Damage (Hidden Hearing Loss)

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

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

Devices

• University of Michigan
• MuteButton / Neuromod

Others

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

The Drug Development Process
Preclinical research: 3-5 years
Phase 1: Several months
Phase 2: Several months to 2 years
Phase 3: 1 to 4 years

The Device Development Process
Preclinical research
Pilot / Exploratory study
Pivotal study
Post approval study

 

[dpdx]

I honestly think we will see something out by 2040. It is going to take a long time. Tinnitus is a phantom sound created somewhere in the brain so it will take time to find a cure/treatment for this.

 

[Tammy Rowe]

Great. I will be 72 then or dead.

 

[Autumnly]

I'm expecting to see a treatment for a subgroup of tinnitus sufferers in about 10 years and several treatment options in 20 years (but maybe I'm too optimistic). I have my eyes on: device by the University of Michigan, medication for hidden hearing loss (Otonomy and Affichem) and XEN-1101 (for epilepsy and potentially tinnitus). Frequency seems to lead the race but as I have only mild hearing loss I don't even notice usually I'm not sure their approach would help me.
I'd be happy with a treatment that would reduce the volume by half and something that I could take/use if my tinnitus spikes so that I could at least keep a certain baseline. For me, it would be a lot easier to cope with tinnitus if my fear of it getting worse wasn't so strong.

 

[Tammy Rowe]

I hope it doesnt get any worse.I got mine from sinus inflammation and middle ear infection with effusion. Which means fluid behind ear drum. I have no hearing loss just got tested. So I really thought it would go away after fluid was gone and sinus cleared up. All the research is related to hearing loss so that dont seem to help someone like me.

 

[Autumnly]

I hope it doesnt get any worse.I got mine from sinus inflammation and middle ear infection with effusion. Which means fluid behind ear drum. I have no hearing loss just got tested. So I really thought it would go away after fluid was gone and sinus cleared up. All the research is related to hearing loss so that dont seem to help someone like me.

I'd say tinnitus caused by an infection is more likely to clear up than tinnitus that is e.g. noise-induced, however, that is based on my personal experience. You only had tinnitus since February, it could still disappear, get quieter or change its pitch to a hiss which a lot of people find more bearable.

Some things I have listed might also help you: the device by the University of Michigan if your tinnitus can be modulated my facial/ neck/jaw movements, maybe drugs for hidden hearing loss (which can't be detected by normal hearing tests), NMDA receptor antagonists or potassium channel openers.

As you're in the early stages I wouldn't recommend focussing on research going on right now but if you want to find out more you can have a look at the research threads.

 

[Tammy Rowe]

I hope you are right! I just went back to the ENT today my ears are clear of fluid. He wants me now to go to another specialist in Detroit MI. Also set me up with some type of hearing aid for tinnitus.

 

[Tammy Rowe]

I just want some answers. All these tests so far normal. I am starting to think all these tests a waste of time.

 

[Tammy Rowe]

Autumnly- you said earlier from personal experience that tinnitus usually goes away from infection. I would like to know what experience you have had. Do you know how long it usually takes for it to go away then?

 

[Autumnly]

Autumnly- you said earlier from personal experience that tinnitus usually goes away from infection. I would like to know what experience you have had. Do you know how long it usually takes for it to go away then?

I don't know if tinnitus usually goes away if it was caused by an infection. Having read many posts on this forum, I've seen a lot of stories where people had developed tinnitus due to a cold or an infection which eventually went away after several weeks to a couple of months or at least became quieter or softer. Some of my friends told me they had experienced tinnitus during a cold and that it only lasted a couple of weeks. However, each tinnitus story is individual. No one can tell you when or if your tinnitus will go away, unfortunately, but I wouldn't assume the worst.

 

[Tammy Rowe]

Thank you for answering.

 

[Greg Sacramento]

@Tammy Rowe I'm been told that there is some discussion going on using the results of some of the biggest tinnitus brain studies to see if a drug is possible for some with tinnitus. I suppose that would be a given anyways. There's also more discussion going on for physical neck and jaw tinnitus. Most new research shows that the jaw should be considered more then just the neck only. Two modulation studies are also in progress.

One researcher helped me with my first onset of severe T by saying that there's several methods that can help. One method is exercise, discussed in the Illinois study. An added method that was given that was also discussed in neuro studies is to use your mind in decision making. Notched music was also recommended. I didn't use notched music, but I did use rain sounds and I did exercise. I also used my mind in a lot of decision making by playing games and trading low price bio tech stocks. I took baths and used mindfulness before sleep. By doing all that, I was at total peace with my T. I did not focus on it. I did not focus on every bit of noise and I still don't, but I always use noise blocking headphones when I feel the need.

Now I have physical tinnitus, jaw and neck. I need to be careful with those areas. I will have to include modulation with that. I cannot use neck adjustments such as the Atlas method because I have heart disease. Waiting for Susan Shore. A pill alone may not help me completely. I have posted links to all studies. None of us has all the best judgement and advise to one's conditions, everyone is different. There's are many conditions involved with tinnitus. You may know more about T than me. Just sharing some of my stuff. May the best come to you.

 

[Tammy Rowe]

Thanks for the advice. I really do need to get off this couch and do something. Exercise for me the last 2 weeks is getting up and going to the toilet. I go to doctor visits and that is about it. I as well listen to rain sounds everything else makes it worse.

 

[AZeurotuner]

Ok what do you mean by spent more time to find my answer? Why not just ask those who may know something? I am new to tinnitus and all I see is Germany and the Netherlands doing anything just wanted to see if there is progress being made where I live.

I feel that a groundbreaking treatment for T probably won't hit the US first mostly due to the convoluted FDA approval process. Of course you could always travel though, I sure would if it was legitimate.

 

[Tammy Rowe]

I would go in a New York minute!

 

[AZeurotuner]

I would go in a New York minute!

That would be a damn good vacation!

 

[Tammy Rowe]

Hell yes!

 

[Contrast]

Cure the hearing loss = Cure the Tinnitus

There is a hypothesis that restoration of hearing via cochlea hair cell regeneration and auditory nerve fiber repair will cure/reduce tinnitus in cases of it being related to sensori-neural hearing loss.

This is based on a model that tinnitus and hyperacusis are caused by higher brain functions amplifying damaged frequency regions to compensate for hearing loss and as a result cause an over active neuronal noise in audiotory parts of the brain (Tinnitus) and amplify frequencies that are normal causing them to sound ultra loud (Hyperacusis)

The "Central Gain" model perfectly describes tinnitus and hyperacusis relating to amplification.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4208401/



Treatment for hearing loss currently in Clinical trials
----------------------------------------------------

All current trials are only for cochlear hair cell regeneration

Frequency Therapeutics

FX-322 – Noise-Induced Hearing Loss (NIHL).
-----------------------------------------------------
GenVec/Novartis

CGF-166 – Hearing loss and vestibular dysfunction.
-----------------------------------------------------
Auris Medical

AM-111 – Acute Sensori-Neural Hearing Loss (ASNHL).



Pre-Clinical trial treatments to repair auditory nerve fibers

Otonomy

OTO-413 – Hidden Hearing Loss (HHL), neuronal growth and repair.

-------------------------------------------------------

Affichem

AF243 – a drug to restore hearing.





Please be patient help is on the way

 

[Bill Bauer]

So I really thought it would go away after fluid was gone and sinus cleared up.

Ears take forever to heal. Your T might disappear 3-24 months after the fluid is gone.

 

[Tammy Rowe]

I am praying it does. It seems to lessen during the day but at night the ringing can get unbearable. I am taking xanax to help with the anxiety. Sometimes that dont even help. They want me to get special hearing aids and put me on anti depressants. All just to cope. I hate this. My life has changed so much. I havent worked since this happened my husband has the only income now. So that adds to the stress.