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To preface this, I had tinnitus before these problems and, while it was there, it was manageable or ignorable. I had more important problems anyways. Here’s the full timeline: One day, at night I suddenly hear a gurgling noise in my left ear. Horrified (I was asleep when it happened) I yelled...

I wouldn't be that pessimistic. The drugs will be released. Whether they work or not (as well as whether their outcomes are worth the price) is in the air but they will come out in the near future. Dr. Susan Shore's device will come out first but that doesn't mean the drugs won't either...

It becomes someone's business when you sit around being rude to other people. If you interact with others or participate in the same space as them, yeah it becomes their business. Don't want to mix your business with theirs? Then don't interact with them. Get rid of this entitled sense of...

Yeah. Melatonin has been shown to scientifically work to reduce severe or chronic tinnitus but we have absolutely no idea why it does.

It's kind of frustrating. We need a way to better image the ear. It seems to be that FX-322's effectiveness will be completely mitigated until we have a way to better understand what it is we're doing. I believe that one of Otonomy's drugs are supposed to repair or regenerate auditory nerves...

I think that it should work (and to some extent it has) but they don't know why it isn't working. Barring killing someone and cutting out their ear, there isn't really a way to determine why more ear hair cells aren't being generated or to even see the distribution of hair cells in the human ear...

Sure but I don't see why you think this means we can't care about potential cures for noise-induced tinnitus. Noise-induced tinnitus is the sort of tinnitus that most people have and which most typically becomes permanent.

@IntotheBlue03, you should also keep an eye on Johnson and Johnson's new drug. It looks like the big-wigs are starting to pay attention to us.

How is that different from regenerating hair cells?

Why doesn't it work at the base of the cochlea?

Why was there a reduction in word scores after 1-2 years?

Where?

Do you have any evidence of that?

That's just a problem with measurement rather than what it actually does. Word-in-noise scores was the metric the FDA wanted them to use for approval so they're using it. There is no reason to believe that it doesn't do exactly what it sets out to do which is activate progenitor hair cells in...

To be honest, based on what I understand, it won't even help people with tinnitus. If your tinnitus is caused by overexcited neurons and damaged hair cells, regrowing new ones won't fix those issues. Tinnitus is likely going to require multiple treatments which undoubtedly would make it a very...

You should note that whether you get any sort of reduction or not depends on the amount of time you spend using the device. For some, they see results immediately after using it while, for others, it takes several weeks. The trial in question was only for four weeks. This new trial I believe...

What is a CE Mark? As for the agencies I mentioned, I couldn't find anything resembling what I found for the FDA.

I'm not asking the researchers questions though, I'm asking people here questions. I was asking people here about how pitch matching is supposed to work, especially considering that people here have difficulty with doing it. Like, take into consideration the actual post you're responding to...

??? I'm just saying what others have said before and giving good reasons for why. I don't know how pointing out that it would be difficult to pitch match (something people have already stated they have difficulty doing) and asking questions about what pitch matching is means that I'm acting...

I question whether you would even be able to determine or match your pitch by yourself. I also wonder how pitch matching is done. Is it when you can't hear your tinnitus pitch? Because I can't hear a whole slew of frequencies.

Desyncra didn't receive FDA approval as a form of tinnitus treatment but rather as a tinnitus masker. Lenire hasn't gotten FDA approval at all. It's a European device but I can't seem to be able to find if it got approval from either the EMA, HPRA, or BfArM. Getting approved as tinnitus...

Since the device requires pitch-matching, it will almost certainly be something audiologists will carry out.

That's not how things work. You need to go through multiple phases of testing, trials, etc. in order to get FDA approval. And with a device like this that typically takes multiple weeks to work, you can't just speed things up. For the record though, Susan Shore's device is probably going to be...

I agree @ColinUK. Fact of the matter is that scientists aren't superheroes. We can't expect them to know everything pertaining to their device; especially considering that they're doing trials specifically to learn about it and its effectiveness. A lot of these questions are only going to be...

They're also finally trying out the drug on bilateral tinnitus sufferers:

I'm not sure what the issue is. I didn't know that this information was available. I just saw that some people were asking questions about the device and decided to ask them to her.

I only asked what was asked here and many of those questions are ones that didn't have answers. For instance, I don't think there is any information in regards to how long it takes for the device for work. Now we know it depends on the person. I asked whether they tested people who could not...

I think we should just keep an open mind. Keep the door halfway open. A lot of people here believe that our only options are either to fall into depression or construct their entire lives around the success of a particular device or drug. You always have the option to keep living.

I sent Susan Shore an email asking her exactly the question being discussed now. Here was our conversation: ------ Me: Hi. I was wondering whether people who can't modulate their tinnitus would benefit from the device. My tinnitus is noise-induced but I can't modulate my tinnitus with head...

Eh, I don't think that's too hard to believe. Perhaps on an anecdotal or interpersonal level someone might have tried the device but I don't think they would use that as any kind of meaningful information. Although, it does look to me like they have some reason to believe that it wouldn't be as...

So the higher the concentration of the drug, the more it will absorb and regenerate? In other words, even if the site of delivery is in one place, the drug itself will spread throughout the cochlea?

This is my concern. I can't modulate my tinnitus. It has a life of its own. Would this device help me at all? Do I have to wait for Otonomy or Frequency Therapeutics or some other hearing loss treatment to fix my tinnitus?

That doesn't explain why higher concentration leads to higher regeneration.

I don't understand.

But how does that work? Why does it have that effect? Shouldn't something which regenerates progenitor cells go by volume rather than concentration?

What if you don't know the exact frequency of your tinnitus so that you can signal time? How long does it take to reduce tinnitus?

How does that make sense? Considering FX-322 (and FX-345) cause the regeneration of progenitor cells, wouldn't a greater coverage cause greater regeneration? Or does the drug cause regeneration even if applied to a smaller or one area? Furthermore, if they learned this, why aren't they carrying...

Then why are they excluding people with tinnitus? Aren't some forms of tinnitus caused by dead or broken synapses? Furthermore, why did Otonomy state that OTO-413 repairs the ear rather than regenerates?

You don't understand. If OTO-413 repaired damage to hair cells, then those with noise-induced tinnitus should be a shoo-in for the treatment because success could also be measured by a reduction in tinnitus.

Isn't OTO-413 designed to repair hair cells? If so, why is tinnitus excluded, considering noise-induced tinnitus is caused by bent or damaged hair cells?

They're interested in commercializing it precisely because it's effective. And commercialization hasn't even started yet (the company has just been founded). And, in regards to tinnitus treatment, I am pretty sure that efficacy is what tinnitus sufferers are interested in. Lenire has failed...

So does that mean "it didn't reach levels of normal hearing" or "I don't know if it reached levels of normal hearing"? Also how does that work? How can it be cumulative? It's not like you'll end up with extra regenerated hair cells. By the way, do the progenitor cells disappear after...

Thank you for your time! How does this compare with normal hearing?

Speaking of audiograms, to what degree were there improvements at 8 kHz? Is it to the level of "normal" hearing? I guess that depends on the actual amount of damage within the cochlea but I am still interested in knowing.

Why would you believe that FX-345 could reach that far back but not Otonomy? How are they expecting to reach that far back? Also for Otonomy, I believe they patented the way they were going to reach that deep so I think that counts for something. Its drug delivery is not based on the drug...

So I won't be helped then? I can only hear up to 12,000 Hz so far. According to the graph, shouldn't I be able to be helped with FX-322? As for the rest of your post, based on what you're saying, do you believe that Susan Shore would not adequately fix tinnitus? I actually have the opposite...

That is highly risky. Perhaps there is a suitable experimental population in the form of people with cochlear implants and people with certain kinds of deafness? I guess it's in this case that something like OTO-313 or OTO-413 would be very beneficial in this case. Like I said, I guess hearing...

As for what I said about Susan Shore's device, I hope I'll get corrected if I am wrong. According to trials, there are some cases where tinnitus only decreased among participants rather than eliminated entirely (only two participants actually reported that their tinnitus was gone). Susan...

I think, in general, tinnitus will probably be solved by Susan Shore's device (or whatever device improves upon that one). Tinnitus is caused by overactive neurons (which may, in turn, be caused by other factors such as sinus infections, anxiety, TMJ, bent hair cells, etc.) so addressing those...

That's true. I now realize that I am wrong about that and that high frequency hearing doesn't tell you too much about how many hair cells are regenerated. Had they achieved 100% regeneration? What was the kind of damage done to the cochlea in the jar? It's my hearing loss that troubles me, not...

I assume FX-345 is going to be more expensive than FX-322?

100% what? That imaging of the cochlea is possible (in which case I would like evidence - I would also like to know your qualifications as you know significant amounts of information pertaining to the ear), or that hearing loss removal is going to be a multi-treatment procedure? Unfortunately...

But the drug is for hair cell regeneration, right? Wouldn't the goal then be to determine if the hair cells have been regenerated? Perhaps a big reason why Frequency Therapeutics hasn't been transparent about why they have the results that they do is because they don't know why they have those...

Do you think that is possible? Also, based on what you tell me, it looks like hearing loss is going to be a multiple-treatment procedure. Perhaps, for hearing loss to truly be eliminated, you'd need a combination of hair cell repair, regeneration, and synaptopathy. Also, based on the graph, is...

So FX-345 is, indeed, "FX-322 but better"?

@Diesel, I have a question. What distinguishes FX-345 from FX-322? According to the PowerPoint, FX-345 enables coverage of the entire cochlea so is it just a new form of drug delivery? If it is, why is it a completely different drug? Furthermore, based on a cursory glance of the PowerPoint, it...

If I had known this, I would not have been as abusive towards my ears as I was. This should be far more well-known. There is allometric scaling which gives them something of an idea as to how much they can expect to regenerate (which is why they can say that they regenerated 40% of ear hair...

Sorry. By that I mean like headphone volumes. What else can we use to measure the amount of hair cells regenerated? That is true. However, many people want to regenerate all their hair cells so as to avoid situations where a loud noise could possibly give them hearing loss again. 50% of your...

How long does that take?

Oh, so does this explain why I can hear up to 15 kHz if I raise the volume high enough but I can't hear it otherwise? Do volumes go by dBs? What is a ceiling effect? Hopefully the drug comes out so we can do some actual appropriate tests. I feel like a lot of what is established in audiology...