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Something like this could help get drugs into the inner ear: https://www.entandaudiologynews.com/media/3129/entma14-shapiro-new.pdf

I would like to see the documentation for this please. Because this is news to me.

F@#k yes, if tinnitus is lowered, it will be a major breakthrough.

With this I could finally get compensation from the work injury that gave me tinnitus.

How did you make the appointment to get this done? Did you just call them up and said "I would like this please"? How did you convince them to do it? Plus how is it going now with the pain?

You say finally. When did you sent them an e-mail?

If anybody is looking for a job as an audiologist at Neuromod, they are hiring. https://www.irishjobs.ie/Jobs/Audiologist-Tinnitus-Assessment-and-Treatment-8358439.aspx

Mentos said this: So going by this info it should be coming to Germany anywhere between now and January 2020.

Why go to Japan when you will be able to get it in the US?

They have facilities in the Americas, Asia/Oceania and Europe. https://www.astellas.com/en/about/subsidiaries-and-locations

Astellas Obtains the Exclusive Rights to Develop and Commercialize FX-322 in Ex-U.S. Markets; Frequency Retains U.S. Rights Frequency will Receive $80 Million Upfront from Astellas with the Potential of up to $545 Million in Future Milestone Payments as well as Double-Digit Royalties TOKYO...

Or it could be that it takes a week or two to take effect or for some up to 6 weeks.

Cool. Any possibility that you could find that comment?

Anybody heard anything about a launch in Germany? Any insider info?

Just open that clinic in Germany already.

Taken from Wikipedia. TNF or its effects are inhibited by several natural compounds, including curcumin (a compound present in turmeric), and catechins (in green tea). Cannabis and Echinacea purpurea also seem to have anti-inflammatory properties through inhibition of TNF-α production, although...

Any news from your source when it is coming to Germany?

@annV Any news on a launch in Germany?

Hopefully clinics in Germany will follow soon after.

To my knowledge there has not been any bimodal stimulation device of this kind on the market before. There have been sound treatments before but the bi means that there are 2 inputs at once. In this case both electrical stimulation and sound stimulation. I would also wager that the other...

dB is exponential meaning that 40 dB is double the volume of 30 dB and 50 dB is double the volume of 40 dB and so on.

Reduction of how loud the tinnitus is.

What is wrong with the testimonials? To the second point we are not owed an answer. Third, yes it is a lottery, they have said as much. At the moment it works for 2/3 of people with tinnitus. As for the relief we just don't know, but if other bimodal neuromodulation tests are to be believed then...

Updates?

In that thread he is then asked if he is referring to this (linking Neuromod) meaning the Neuromod device and he answers yes. So he is referring to the Neuromod device after all.

Nobody knows for sure if it will work for hyperacusis. Because we truly don`t know what the root cause of hyperacusis is at this time. But there are some theories about what the cause could be. One theory is as follows, taken from...

I would think that if it had to do with investors the word investment would have been used and not revenue.

That is also the conclusion that I came to.

I also don't have access to that article, sorry.

Neuromod, a healthcare start-up developing treatments for tinnitus, is in talks to raise up to €24m in investment. https://www.thetimes.co.uk/article/neuromod-buzzing-in-24m-tinnitus-boost-rg0b5tgcq Accounts just filed for the business state that the directors are in “advanced discussions with...

https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

Try Twitter. I have sent them an e-mail long ago but never got an answer. But on Twitter they answered.

Yes. I take it you don't feel the same?

Was Dr Hubert Lim part of the original team of researchers which was done at the University of Minnesota? If that is the case then that gives a lot of weight to Neuromod's device I think. http://bme.umn.edu/people/faculty/lim.html This is some of the work he and his team have worked on...

I got this from their site. It is a good read. Phase II – Parameter Optimisation and Patient Subtyping Study: https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf Trial design: The Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) study is a...

But they are going to do so. They have already said this multiple times.

When it comes to Denmark you will more than likely be able to get it for free.

Then it is good that there is an organization that is working to “cut the red tape” for drugs at the FDA. Namely Faster Cures https://www.fastercures.org/ “FasterCures praises efforts to modernize FDA drug review programs This morning, U.S. Food and Drug Administration (FDA) Commissioner Scott...

@Steve said this some pages back:

How is it going with the Q&A @Steve?

Long story short: Positive data from trial 1: https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/phase-i-safety-and-feasibility.pdf There has been positive talk about the 2nd trial also. No data officially released. But some of the staff on here have given hints...

It will be able to benefit from fast track if they consider hearing loss a serious condition. Hearing loss from WHO: Key facts Around 466 million people worldwide have disabling hearing loss (1), and 34 million of these are children. It is estimated that by 2050 over 900 million people will...

If I remember correctly it is only for terminally ill patients.

We just don`t know enough about tinnitus to say that it is fully in the brain, the ear or both. There is evidence that points to some of these. Like getting a cochlear implant or hearing aids will help with tinnitus, or that bimodulation helps with tinnitus. Hopefully FX-322 will shed some...

This would be the only way for the FX-322 to get in people’s ears faster. https://www.fda.gov/forpatients/approvals/fast/default.htm

Either way I think many questions will be answered for better or worse.

I know somebody already said that the device is not dependent on the peer review. But I sent a tweet to Neuromod to hear it from them. So now the question is will they wait for the peer review to be published or not before putting it up for sale in the EU.

Hopefully the upcoming Q&A will give us some answers to these questions.

Phase 2 will start next year and by the end of 2019 end we should see the results of that.

Just send a mail Jeff Karp`s way to see if he answers.

Does anyone know if FX-332 is going to be or has been planned to be “fast tracked” by the FDA/Frequency Therapeutics under one of these 4 conditions: https://www.fda.gov/forpatients/approvals/fast/default.htm

Very early. Phase 2 starts in 2019. Let's say that takes 1-2 years. Next is a phase 3 that can take anywhere from 1-4 years. There will probably be a peer review, add 1 more year. I would say anywhere between 2022-2026.

That's me. I asked him this: "But I would like to ask you if your method will also repair/regenerate the auditory nerve/connections from the nerve to the hair cells?" Mr Jeff Karp responded: "Thank you for the note - we have some evidence to suggest the answer to that question is yes - but...

https://hms.harvard.edu/news/boldly-go This tech is also from Harvard. I would think that they are related after reading the following: "To address these challenges, Betzig and colleagues combined two technologies: lattice light sheet microscopy, which Betzig developed in the early 2010s, and...

From their Twitter:

The Neuromod device (MuteButton) is CE marked. For us in the EU this means that there is one less obstacle to get passed before it can come to market. Our product is approved for sale within the European Union (CE marked) and is protected by a growing portfolio of issued and pending US...

That sounds a lot like the basis of the neuromodulation devices that are being worked on at the moment.

@Steve could you possibly go into a little more detail about this device and hyperacusis? And was it hyperacusis with pain?