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This is already occurring at present. Pretty much there are two main aspects being assessed right now to improve this. The first is that there's tonnes of effort/research/work being done to preserve hearing in cochlear implant candidates. Currently there has been some major improvement in this...

A lot of individuals do not have hearing loss below/at 2 kHz anyway who would be in the target group for Frequency Therapeutics. Thus this is why even in certain CI candidates, there tends to be an approach where they don't do anything with these lower frequencies. From a lot of evaluations...

They would, however they would reduce a lot of the lead time since a lot of the lead in work such as the preclinical studies etc is already completed. Well wasn't the reason people improved in the FX-322 placebo group due to them falsifying their word scores to enter into the trial though? Then...

There has already been a lot of development around nanoparticles and therefore it would seem a plausible and logical option.

Correct, which is why an implant is seen by many as being vastly superior to pretty much all hearing aids. As a result the only way improvement could be obtained is by cell/synapse regrowth.

There have been claims from some saying they'd eliminated hyperacusis also with the implant.

I think it will get released right after it is given approval. At this stage it seems that the biggest barrier's been getting it past that.

The problems with audiograms are actually absolutely understated too. There have been recent examples of the audiogram being the sole measure that both audis and doctors use for determining things, despite there being countless examples of how flawed this is. It is exactly why it isn't in any...

There was commentary put out from some about how hearing loss leads to dementia through the recent results of a fairly sizeable study and some groups (with very vested interests) commented about this. There has been further commentary come out from parties with relevant expertise and knowledge...

Even if it is developed as a speech understanding drug, this is still helping with hearing loss even if there is no improvement on the audiogram. One such argument is that it is triggering the inner hair cells which deal with this.

Why would that stop speculation about how they can get the medicine the whole way through the cochlea? Can't improve one's understanding of speech if this is not doable...

If you mean will the exclusion criteria likely exclude groups of people who have got tinnitus from participating, then the answer is likely to be no, it will not. Noting cases of sudden hearing loss to date, a lot of them have tinnitus as a result of it.

So if no one benefitted from the medicine then, explain why those who received it subsequently demonstrated improvement? I think that @Chad Lawton summed things up quite well with his comment.

I get this study now, however it seems on face value that it is only referring to a specific subset of tinnitus and not all kinds of tinnitus. Thus this makes things much clearer.

I don't get how blood flow can be related to tinnitus at all.

Not necessarily. There are people who have got a moderate hearing loss who perform very poorly on the speech recognition components of the tests, while there are people with a severe to profound loss who perform very well with the correct volume being given to them. There might be an overlap...

Could be that the data on the website has not been updated.

Is that why Frequency Therapeutics had successful outcomes/measures from both in vivo and their single dose trials then? That doesn't flat out demonstrate that the drug did not work.

If something worked only to suppress the symptoms then I think that this would be a real win and most people would be satisfied with that irrespective of whether or not other treatments come about.

This debate has been had before but basically there is not much debate as to where it comes from (brain) but the debate is around whether it is initiated by a brain issue or an ear issue. It is the thought from many that ear issues are what causes tinnitus.

This is not the first time that there has been a treatment trialled a significantly long time ago which has not progressed further for a number of years too. The difference is that there's tonnes of progression in terms of medicine development and research techniques since then. RL-81 is a...

Hubert Lim was working on his device at the University of Minnesota and then he abandoned it to go and work with Neuromod (Lenire).

Cochlear Implants.

I don't think that this necessarily means that they have nothing to commercialise at this time. Rather it sounds like they need to work out or be told by the FDA what they need to do in terms of making the safety trial component satisfy their requirements. Right now I think that the device is...

Taking that type of approach leads to problems getting things passed/approved by the FDA. From what we have seen thus far, the FDA requires very specific and very narrow criteria to be met in order for a medicine to go through a clinical trial. This includes trialling a set dose size on a...

This is quite questionable though as a lot of people are helped by medications like penicillin etc and the success rate would be also significantly greater than 30% as well.

I think that there are three things you need to consider with the outcomes of this OTO-313 trial. 1. 43% gained benefit, which is positive. The trial did not consider any factors which might have influenced this result though such as their type of hearing loss or its level. 2. The acute phase...

I think that this is somewhat promising. I thought that there could be a longer delay before it is in the trial phase. It is just promising that he is looking to try and not only get the medicine to a safe standard but is also trying to make a positive difference too though.

I think that the benefit with the Otonomy medicines might end up being their delivery method. Not guaranteed but if their last dose got done in July and Otonomy tests up to three months after the dosing, then this means that October would be when this happens. No evidence to confirm that this...

Unfortunately I do not think that they will respond to emails about asking for information relating to clinical trials, as they usually have to keep things closed until they release the data.

Interestingly multiple of these papers don't actually rule out the use of intratympanic injections totally and also point to issues such as the technique and substance used among other factors as being the issue.

Yes I think that the administration method might end up being the bigger culprit when it comes to the effectiveness of the medicine currently. There are a plethora of other options obviously to evaluate when it comes to dosing such as slow release gel, bigger volumes and cochlear pumping. Until...

I believe it might have hence how I stated that there tends to be an analysis of safety outcomes if it is required.

Phase 1 is where safety is predominately tested. Thus this would mean that the treatment would have likely either got canned or been made to fix the safety issues first before it could proceed further if it was deemed to be unsafe at this point. Phase 2 and 3 are primarily efficacy trials...

I think that the biggest issue that Frequency Therapeutics has got right now is that it needs to reevaluate both the dosing methodology and also actually whether the medicine properties are sufficiently targeting what it needs to target too. There is evidence which indicates that the medicine is...

The question is though whether the placebo would have mucked up the dosing of the medicine in the same way. At present there is no information to confirm or deny this.

I don't think that there was any evidence at the time to demonstrate that the multi dosing would result in adverse outcomes which was why Frequency Therapeutics ran with it. It is also the case that Frequency Therapeutics did do only single dosing as an element of their mucked up Phase 2 trial...

The candidacy issue is indeed Frequency Therapeutics' issue. The dosage schedule not so much. Majorly difficult to know and/or predict how a medicine will operate until it is trialled.

Why do you think Frequency Therapeutics botched the clinical?

Yes if these devices do do the things that the developers/researchers believe that they can do then I think that there can be a real benefit from them, especially with their comparisons to normal hearing ability.

Not to mention that there tends to be little merit to their claims and little evidence it will succeed either. Essentially it just looks like they are fishing for claims. They are going to have to demonstrate that Frequency Therapeutics exaggerated claims and presently there is very little...

Go and have a look on the Cochlear America site or obviously other sites like Australia etc. I'd upload it, however it is too difficult to do on my phone, sorry. The criteria is from moderate to profound hearing loss now and no longer profound hearing loss exclusively. Essentially the criteria...

Not necessarily. No longer is there a requirement of profound hearing loss before you meet the criteria for a CI.

Pivotal trial = Final trial before FDA Approval is given to a medicine. Medicines can be released for compassionate/expanded use after Phase II, however this does not mean that they have been given complete/final approval.

I think that there wouldn't have been much discussion on OTO-825 or OTO-6XX because they are also actually not out of the pre-clinical work phase as yet either.

This isn't necessarily true. A lot of people have hearing loss from the audiogram perspective and no tinnitus.

I think that these guys are actually on a promising pathway with what they are doing when it comes to the research and techniques side of things.

This organisation is right here in Melbourne.

I have seen indications which suggest the opposite when it comes to tinnitus that it is often present in older people. The Hough Ear Institute Pill is interesting. It apparently just doesn't solely have medicine for synapses alone according to what they have put out and while I think that there...

Looking at the comments from Otonomy, it seems like they aren't able to comment and/or determine whether the medicine has any impact on tinnitus or not at this point.

Thanks. I had not seen that tinnitus was commented on in the original trial results. Can you show me where in the transcript it says this as I cannot see any mention of tinnitus in the OTO-413 section?

- To be rational when it comes to the Hough Ear Institute pill, the initial trial was done with people who indicated that they did not have tinnitus etc. Essentially this demonstrates that it was not possible to determine whether the medicine had any benefit or not for tinnitus. - Also wasn't...

People in academia wonder why we don't take a lot of their work seriously - answer they come up with silly stuff like this which has no benefit or rationale behind it.

The thing that we are aware of is that there have been delivery issues with the current method. Most certainly this is why other firms have not utilised this approach and also why Frequency Therapeutics has looked at investigating alternative delivery methods. There have been three trials that...

It is a problem regarding tinnitus and using hearing aids when related to no hearing loss on an audiogram. As a rule I cannot see how tinnitus is completely in the brain as some doctors claim that it is when the evidence doesn't conclusively support this at all.

The Oticon More technology is pretty positive when it comes to dealing with tinnitus. It works in a manner which is completely different to other hearing aids. Another thing is that hearing aids cannot assist with synaptic elements of hearing and if the research is correct that synapses and...

It is inevitably possible that multi dosing could work. What would have to be identified first though would be how long it takes for a single dose to provide benefit if this treatment is successful and then once this is finished then look at proceeding to a subsequent dose.

The thing that has not been covered in his analysis relating to hearing aids and tinnitus relates to three key things I believe. 1. I agree with what you say about hearing aids and their effect on tinnitus. There are limitations to the amount of extra noises that can be provided from a hearing...

I don't know what you mean by larger? Looking at it, it won't be larger than the first single dosing trial in terms of numbers.

Totally true. The first change to this trial will be the fact that participants will get screened appropriately to start with and actually demonstrate that they are an appropriate candidate for the trial.