Given your silence, I wonder if those who participated in the trial can not provide more details to others?
That’s one way to look at it. Another, is that the graphically depicted information you requested, may not be simple to provide.
very sorry…I did not notice all this response until now. it was 2 years ago and from my email I have my final results only. I have asked team to send me before and after again to me. I will also then ask them if I am authorized to share. but like I said the gains were above 4k range and i think it was 5 to 10 db gain.
Sounds about right. I posed this question back in 2020:
I think the second one is more accurate. I think the first is talking about energy levels and not perceived loudness.
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That was @Neville’s opinion too. It was like the first quote was almost an outlandish thing to say. That’s FX though. The science might be great for all I know but their relentless self-promotion makes me skeptical.
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correct, It could be the person having a bad day or a good day that could make a different… 10 db is not going to make a different…
I trust the FDA. Don’t you?
They just started the trial for the newer version (FX-345) in Dec. Supposed to penetrate deeper into the cochlea to address lower frequencies. I’d happily take an extra 10 db across the board.
Jordan
But test-retest variability diminishes in importance with enough trial participants and enough tests per participant, right?
Depends on definition of “importance.” 10dB may be statistically significant, ie a “real,” repeatable difference, but 10dB is still not going to make much difference to somebody with a 90dB loss.
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Would you say that someone with an 80dB loss shouldn’t care if they lose another 10dB? That’s logically the same thing.
I don’t know about “not caring,” but I don’t think it’s going to make much difference.
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“In general, as reported by biotech news site Evaluate, the FX-322 trial results have largely been lackluster. In fact, Bloomberg Law reported in summer 2021 that investors have filed suit against the company for making false claims about the clinical trials.”
I figured this would be the case. They never answered my email asking if they were able to treat profound hearing loss yet and what kind of numbers they achieved. No email answers to a detail request is usually a bad sign.
FX changed gears when the audiometry scores were lacklustre. It’s all about word recognition scores now. I haven’t seen an explanation that makes sense to me why minimal changes in thresholds would lead to significant improvement in ‘clarity’. If I were going to have someone inject something into my ear, I’d like to think that they knew why.
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I know some people over at the tinnitus forums got replies- even from Jeffrey Karp himself no less. I don’t think they have the staff to answer every email. Many questions they don’t have the answers to because they’re still trying to find the answers.
If there are no real risks in testing the drug, why not fast track it? Even if it proves lackluster, things will be learned and no one gets hurt but investors. And that comes with the territory.
It is being fast tracked. People do get hurt though, just not in obvious ways. This drug was hyped from day 1 and large numbers of people with severe tinnitus pinned their hopes on it. The hype worked. The founders of FX got very rich- or even richer than they were before. The bad news is that when the multi-dose phase 2 trial crashed, those who were heavily invested in it emotionally took a major psychological hit. Some of them took a financial hit as well because they invested to try to support the company. Source: hundreds of pages on TinnitusTalk forum, watching it all unfold.
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That article was from 2019. Is that still the case?