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Best is to rest this thread at this page no. 666.

A clinical trial investigating the use of Chinese medicine formula (Bushen Huoxue Tongluo or "BHT") for the treatment of chronic subjective tinnitus is underway. It has been active for a few months now, and continues to recruit patients. Link: A Chinese Medicine Formula (Bushen Huoxue...

First they ask for donations, then they say pill, then they say a journalist got things wrong, then Oblato's website mentions nothing about hearing loss in their pipeline, then they say it's a cancer pill that works for the ears, then they say their pill can cure everything from hearing loss...

Yes, and I wonder why tinnitus would be reduced by calming down the nerves if the input from the cochlea to the brain is still missing...

Is there any FDA Calendar for upcoming "Medical Devices"?

Can someone refresh my memory? OTO-313's (for tinnitus) compound is Gacyclidine. What is the mechanism of action for this drug? If this doesn't restore hair cells or synapses, how is this intended to quite tinnitus? Or to rephrase the question, this compound will do what to the damaged cochlea...

My guess is a Phase 3 FX-322 trial will run simultaneously with a FX-345 phase 2/pivotal trial in 2023... Since Frequency Therapeutics is on a fast track designator, an approval for the drug can come in 6 months after the above-mentioned trial in 2023.

Inner Hair Cells: Speech Outer Hair Cells: Audiogram

Erchonia® HLS™ for the Relief of Tinnitus Symptoms Trial is Active, scheduled to finish in January 2022. This study is to see if applying red low-level laser light can help to reduce tinnitus symptoms. A Pilot Evaluation of the Effect of the Erchonia® HLS™ for the Relief of Tinnitus Symptoms

As soon as they publish the failed results of the severe hearing loss trial in November I'm buying the dip, it will be great to start again at a position of $4 or $5 per share! My fingers are ready...

Try this with the Aftershokz:

Quick update: I have been using it for few hours now, not sure if it's placebo, but my tinnitus has gone down dramatically! Let's see how it goes :)

Or it could be like Elizabeth Holmes, founder of Theranos…

I just got mine today! I installed RAIN App (white noise) on my iPad and paired it with the Aftershokz and it pretty cool… I have it on very low volume as Im scared it would make my tinnitus worse… hoping to hear reviews

I hope this sentence satisfies you: If the root cause is not fixed at the site of damage, then we need a drug to shut the tinnitus up which is located and perceived in the brain...

Yes. Tinnitus is in the brain.

Man, in simple English, treating the root cause fixes tinnitus... If the root cause is not fixed, then we need a drug to shut it up...

You misread what I wrote: Damage can occur in either one of the below: Brain Nerves Auditory Inner ear Middle ear Blood flow Hormones Cholesterol Etc... Tinnitus alarm is in the brain...

They already know and examined ex vivo extensively... Tinnitus is activated as soon as any damage occurs in the brain/nerves/auditory/inner ear/middle ear/cells/etc... They already know which area in the brain the tinnitus source is... The question is, which substance can instruct the...

I recall seeing a possibility for the drug reaching 6,000 Hz.

Phase 1: currently being finalized Phase 2: we can expect it to start in December 2021, duration 1 year Phase 3: duration 1 year FDA: Apply for Approval (a few months) If David and Team decides to go watch the World Cup FIFA December 2022 in Qatar, it might take a bit longer. Yes, so far it...

If you jump to the conclusion section, it will be scarier: “Even the median variation in sound pressure at the ear could contribute an error of 4 dB in hearing threshold values, which is sufficient to cause misdiagnosis on an audiogram. Where the degree of variation is at its highest, there is...

“Manual pure tone audiometry is considered to be the gold standard for the assessment of hearing thresholds and has been in consistent use for a long period of time. An increased legislative requirement to monitor and screen workers, and an increasing amount of legislation relating to hearing...

Many sources state the below: “Up to 10 dB is therefore an acceptable margin of error” Single Audiometry – A Basis For NIHL Claims Handling Schemes? You want all sources?

You can just say not sure...

Sorry but the Phase 1/2 was done before fixing the bias glitch, so we can consider this study as bias also... For me, the severe trial will give us a FINAL conclusion about this whole thing...

Sorry to break it down for you but 10 dB Improvement is not an accurate measurement. 10 dB is not a tangible gap. 30 dB and above can be considered as an improvement bearing in mind how these tests are being measured...

I feel not everyone is understanding what's happening, here is an example: Michael and Laura are desperate to get FX-322, so they both apply for the Phase 2a trials: Michael in reality can hear 30 words out of 50, but as he is desperate, he fakes his initial screening to get into the trial...

Yes, those patients had improvement in word scores only. With current formulation and delivery method no audiogram improvement was ever recorded till date. In future studies, Frequency Therapeutics wants to try multiple doses far away from each other to see if it provides better results in...

You cannot take or compare anything from Phase 2a. Phase 2a does not have a verified baseline from anyone, so please stop considering Phase 2a with anything. Phase 2a is just a complete garbage. If you don't have verified baseline from either placebo or candidates who took the drug, then it's...

You got many things mixed up. I'm using my phone so I'll try to be as clear and brief as possible: Phase 1/2 is being claimed as successful, it was placebo controlled, and had good responders. But the issue here is that this study was done way before they learnt their lesson about bias...

Sorry but the Phase 2a was not an open label study... Everyone agrees that Phase 2a was a failure... The 3 super responders from Phase 1/2 is questionable... The improvements from Phase 1 moderate open label study is being claimed as legit...

Severe trial is estimated to end in September, meaning readout will only be by November 2021. That's IF they have finished recruiting now... which apparently is not the case because they are still looking for candidates to inject with FX-322...

Thank you @Diesel for your input, I appreciate the time you always take answering posts from members... I also really want this to work!

So since November 2, 2020 they haven't been able to find 30 candidates from any of these cities: Michigan, Nebraska, New York, South Carolina, Texas, Virginia... Ok, cool, I respect your opinion... Can someone living nearby in any of the below cities enroll for their severe hearing loss...

ClinicalTrials.gov for severe hearing loss group just got updated. They are still recruiting... Also completion date has been pushed towards September 2021... This was supposed to be completed and data being analyzed by now! Oh lord help us all... I can't hear bad news any longer. I am...

Mmm... some minor adjustments in your response: Short Interval Multi-dosing: No. Long Interval Multi-dosing: Maybe. Single dose for Audiograms: No. Long Interval for Audiograms: Maybe. Speech improvements for the right patient: Maybe.

It's for this very reason that they should have done a placebo-controlled Phase 1 for moderate hearing loss. It was their chance to prove their claim, regardless if it costs money or time... This is a public company... and the public have the right to this. Instead of going out tweeting...

CEO gets to buy shares at $0.61... :)

And to add insult they posted and hired a Chief Manufacturing Officer!

Why Frequency Therapeutics did NOT do a Phase 1 placebo-controlled study for moderate hearing loss cases? They did it as an open label. Why did they not also conduct a placebo control for the group that they initially believe has responded to the drug? Are they scared of something? I mean, they...

I wonder what would be their excuse if severe hearing loss results fails... They will blame it on current delivery method :(

Let's first be able to scan cochleas and be able to analyse images of what's inside...

Frequency Therapeutics claims that FX-322 improves word recognition in mild to moderate cases (sensorineural hearing loss). Poll: How truthful do you think that is? Truthful, enough evidence gathered, I trust their claim → Give this post a Thumbs Up. Confused, still early to tell → Give this...

It should have been done to both ears (one drug and the other placebo) in order to cross check and verify if the candidate was lying… In the 111 study open label, the candidate knows exactly which ear is being treated and which not… so how is this going to be validated? You hope that the...

@Diesel “The FX-322-111 study was not placebo controlled, though the study analysis of untreated ears also showed zero percent (0%) exceeding 95% CI from the baseline to day 90 for the WR test” Can you please advise for the study FX-322-111, did the candidates get treated in 1 ear only? And...

What makes you feel sure that those who showed 10% improvement did not fake their WR also? Why do you only consider the placebo group as biased and not also the ones who improved?

Recruiting: OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

No issue. OTO-413 is just starting recruiting. OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Gentle Reminder - Goldman Sachs Conference is tomorrow. To avoid confusions on the timing, below are the actual timings depending on where you are: EDT 8:00am Panama 7:00am New York 8:00am France 2:00pm Germany 2:00pm Russia 3:00pm They might allow to ask questions in the end, so make sure...

This guy explains clearly the cochlea. There are some interesting facts that I think everyone here should know, e.g., sound vibrations make liquid move around inside the cochlea, the functions of inner and outer hair cells, and information on the feedback loop. In one part of the video he...

No source. It was an edit over an audiogram referring as to which level of hearing loss FX-322 has the potential to treat...

Great info. So we can say these are the 2 possibilities going on preventing the full effect of the drug:

It is already confirmed that FX-322 can pass through the Round Window. The question was, once the drug has already passed through the Round Window and is inside the cochlea, everything there is liquid, so the drug can diffuse everywhere:

If anyone can advise please, if the cochlea is liquid, why is there a problem with the delivery?

So if the cochlea is liquid, why is there a problem with the delivery? The drug would diffuse everywhere!

Maybe FX-322 does not reach the Outer Hair Cells. That could be the reason we are getting a response on word scores only since Inner Hair Cells are responsible for word scores. For example, here we could see the drug just flowing over the Inner Hair Cells, and not reaching the Outer Hair Cells:

It means the environment and condition of the support cells in the ear are healthy enough for the drug to carry its intended purpose.

FX-322 works. To see it in Audiograms, you have to wait longer while they modify the delivery method.