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Audion Therapeutics Trial

#35
Paulmanlike said:
Who's applying
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I would! But I don't qualify I'm afraid.

The team are looking for people aged 18-80 years with mild to moderate sensorineural hearing loss, who are either using or have been previously offered a hearing aid. People are eligible to take part in the study if they have had hearing loss for less than 10 years. Participants must be willing to refrain from wearing their hearing aid in the ear to be treated for three weeks, the duration of treatment.
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I have some mild hearing loss. I suspect it's worst at 6000 Hz, but it hardly registers on the audiogram.

It did register on one audiogram, with a sharp dip. The first audiogram I ever did! But since then, I think I have taken two new tests, and the dip is barely visible on the new diagrams. I think it was around the same time that my tinnitus changed character from a hissing or static background noise to a noticeable tonal screeching kind of sound.

I speculate that the cells had deteriorated more by that time since the initial noise trauma, and/or the brain cranked up the gain to pick up ~ 6K frequencies. I don't really know what happened inside the ear or the brain. I just know that something did, but the events already began to unfold about a year earlier when the noise trauma happened. The sound stimuli was also about 6K, so it all fits.

Depending on the severity of the damage, I guess it takes different amount of time for the cells to deteriorate and for the brain to make any needed adjustments, before you start having tinnitus.

This all reminds me why we need better diagnostic methods. The audiogram has played out its role. It may serve well as a preliminary hearing assessment tool in healthy individuals, but it's not well suited for investigating pathology in diseased ears (and brain).

People who suffer from tinnitus, and consider this to be more of a problem than their hearing loss, are not eligible for the study.
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That's me alright.

More info here:
https://www.actiononhearingloss.org...rtunity-to-take-part-in-a-clinical-trial.aspx
 
#36
You know Frequency TX will be watching this Audion trial very closely since their hearing restoration drug is based on the same premise. If Audion's trials are successful, there's even more hope for Frequency's solution!
 
#37
I have in fact left them a message, but I don't expect them to roll me in. First of all, my main problem is tinnitus and not hearing loss. Plus, I am not a UK citizen. They have said they will reach back to me about the citizenship. They are still considering taking in international patients.

On a second thought... considering that they all say that tinnitus is a symptom... a symptom of hearing loss, and I do in fact have some hearing loss... it should not be a question of what bothers you more, hearing loss or tinnitus! That's really silly when you think about it. They are one and the same really, or one is a symptom of the other. And I do have some visible hearing loss on the left ear.

So to participate in a "hearing loss" trial? Or not to? That is the question! Of course, we can wait for a "tinnitus trial"... treating the symptom as if it was a disease, rather than treating the cause... namely hearing loss. Then when you ask the good old doctor about tinnitus, he says it's a symptom, not a disease! They all wacko! :wacky:

Flamingo1 said:
If Audion's trials are successful, there's even more hope for Frequency's solution!
Click to expand...
I sure hope so! :)
 
#38
Samir said:
I have in fact left them a message, but I don't expect them to roll me in. First of all, my main problem is tinnitus and not hearing loss. Plus, I am not a UK citizen. They have said they will reach back to me about the citizenship. They are still considering taking in international patients.

On a second thought... considering that they all say that tinnitus is a symptom... a symptom of hearing loss, and I do in fact have some hearing loss... it should not be a question of what bothers you more, hearing loss or tinnitus! That's really silly when you think about it. They are one and the same really, or one is a symptom of the other. And I do have some visible hearing loss on the left ear.

So to participate in a "hearing loss" trial? Or not to? That is the question! Of course, we can wait for a "tinnitus trial"... treating the symptom as if it was a disease, rather than treating the cause... namely hearing loss. Then when you ask the good old doctor about tinnitus, he says it's a symptom, not a disease! They all wacko! :wacky:


I sure hope so! :)
Click to expand...

I would imagine because their primary target outcome is treating hearing loss, they would not want their outcome to be measured by a change in tinnitus severity. Remember that hair cell damage due to hearing loss is only a theory to why tinnitus occurs yet a very strong theory indeed.

I wish you all the best though, I do hope that applicants will report their progress on this board.
 
#40
Tinnitus patients are quite unreliable, it's a subjective condition and the only way to measure it is through a visual analogue scale.

Look at the conflicting reports for LLLT, how can one for example measure a 20% decrease in tinnitus and put in down to a certain treatment.
 
#41
Paulmanlike said:
Remember that hair cell damage due to hearing loss is only a theory to why tinnitus occurs yet a very strong theory indeed.
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It's not even a theory yet! It's a hypothesis made by ENT doctors. One that I sure hope will be put to rest once and for all. Sooner rather than later, so we can move on to other treatment options.

Reinier said:
I wonder if they don't aspire candidates that regard tinnitus as their biggest problem because of possible anxiety issues?
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Yeah, it's like they want to blame it on something else, other than hearing loss. Yet they talk about it like it's symptom and they deny us the right to call it a disease.

Paulmanlike said:
Tinnitus patients are quite unreliable, it's a subjective condition and the only way to measure it is through a visual analogue scale
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Yup! We are the worst! :D
 
#44
@Samir You have to understand that it's a hearing loss trial, not a tinnitus trial. They want to know if their drug can restore hearing, not if it can lower or cure tinnitus (though it's a secondary outcome and will be monitored during the study).
 
#46
Paulmanlike said:
didn't frequencies founder state tho that they are assuming it should work for tinnitus as they are fixing the root cause
Click to expand...
The Leviathan said it might work if your tinnitus is caused by dead hair cells.

Screen Shot 2018-09-05 at 0.07.41.png


I believe this is why tinnitus is a secondary outcome for Audion. They probably think their drug may affect tinnitus, so they're gonna monitor it, too, during the hearing loss trial.
 
#47
acufenero said:
You have to understand that it's a hearing loss trial, not a tinnitus trial.
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Man, that is some flagrant false advertising! :eek:

acufenero said:
They want to know if their drug can restore hearing, not if it can lower or cure tinnitus (though it's a secondary outcome and will be monitored during the study).
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What do you suppose they will do for a "tinnitus trial"?... :barefoot:
 
#48
It's at least good news that it's a secondary outcome and they will report if any effect. Personally prefer to be tinnitus free than a mild hearing loss.
 
#50
acufenero said:
I believe this is why tinnitus is a secondary outcome for Audion. They probably think their drug may affect tinnitus, so they're gonna monitor it, too, during the hearing loss trial.
Click to expand...
Monitor it? How so? If they only take in purely "hearing loss" patients? There is only place for 24 patients in the first phase of the trial.
 
#51
Samir said:
Monitor it? How so? If they only take in purely "hearing loss" patients? There is only place for 24 patients in the first phase of the trial.
Click to expand...

Good question. Although they haven't really excluded tinnitus patients from their trial, they just don't want that to be their first complaint.
 
#52
Samir said:
Monitor it? How so? If they only take in purely "hearing loss" patients? There is only place for 24 patients in the first phase of the trial.
Click to expand...
Participants are allowed to have tinnitus, but it can't be their main complaint. If they do have tinnitus, it will be somehow monitored.

From the trial site:

Participant exclusion criteria
1. Presenting with a primary complaint of tinnitus
[...]

Secondary outcome measures
[...]
3. Tinnitus measured using a questionnaire at visit one, two and three

"As this is the first time the drug is tested in humans, it is not clear what the exact risks will be, but specific functions like hearing and tinnitus, balance, facial nerve function and taste are monitored closely for any changes throughout the study."
 
#53
Crazy to think that after all these years of talk of regenerating hair cells they are finally moving into the clinic in the next couple of months or so. This will be a major breakthrough if successful. Even more major if it helps tinnitus. To think it was once considered permanent to lose them and now there is hope that this may not be the case!!
 
#56
jer said:
Why would it take 3 years for the results of the first 2 trials to come in? That seems like an insanely long time to me!
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It's two phases. Phases can be whatever the researchers want or need them to be. Generally, not always, phases can take one to one and a half years. So three years is about right. But I share your frustration and impatience!
 
#57
ruben ruiz said:
Way too long!
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Note however that the Regain project will end on 2018-10-31.

I hope they replace it with something else.

So I would think of those dates as preliminary. Scientists always say that the cure will be out in 10 years. It's always 10 years. They say so when they have no clue when they will have something.
 
#58
As someone without hearing loss and generally good hearing, but suffers with tinnitus, should I be excited about this?

I don't want to hope for something that will not benefit me, although I hope the best for you lovely people.
 
#59
Paulmanlike said:
As someone without hearing loss and generally good hearing, but suffers with tinnitus, should I be excited about this?

I don't want to hope for something that will not benefit me, although I hope the best for you lovely people.
Click to expand...

You list your T cause as "Noise", which means your hearing apparatus is probably somewhat damaged from that noise, possibly to the point of being a contributing factor to your T. Not all damage in hearing can be measured (basically, it's currently impossible to claim "I have no hearing loss" - but you could say "I have no measured hearing loss": remember that absence of evidence isn't evidence of absence), so it is possible that treatments that enhance hearing abilities on people with hearing loss would be beneficial to you, in addition to having a chance at addressing your T.
 
#60
My hearing loss is a problem but I won't apply : Audion's trial will leave you with fewer (or no) supporting cells left. I want to be able to apply to Frequency's, which targets a more conservative approach. If Frequency fails and Audion succeeds, I'll still be able to benefit from Audion's drug, which will be closer to the market then.
 

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