Hough Ear Institute's Hair Cell Regeneration Project

[ajc]

I definitely do think that there is some really interesting information coming from Hough Ear Institute if you press them on it.

Carry on the good work! It's important someone presses them on it. It smells fishy. Also how they seem to not have any real two-sided connection with the pharma company, saying "we have not yet heard..."

Can you imagine Frequency Therapeutics or Otonomy being this unprofessional or disjointed? Justin De Moss probably writes his responses in his bedroom on his iPad. Hough Ear Institute desperately needs to be clearer in their messaging. The vagueness and discrepancies hurt them.

 

[Mica Rambin]

Sounds like we may also need to contact the biotech firm to get more answers about the progression of these studies. I understand that both Hough Ear Institute and Oblato need to be careful about what they communicate with us for legal purposes. I just hope they don't play hot potato between each other as we ask them questions. As I said before more frequent communication from them would improve public confidence. They should try to upload a YouTube video on their channel every week.

 

[Drachen]

Answer from Hough Ear Institute:

There is something very off-putting about the way they worded this response.

Their defensive attitude and lack of any self-awareness is remarkable.

 

[tommyd87]

Sounds like we may also need to contact the biotech firm to get more answers about the progression of these studies. I understand that both Hough Ear Institute and Oblato need to be careful about what they communicate with us for legal purposes. I just hope they don't play hot potato between each other as we ask them questions. As I said before more frequent communication from them would improve public confidence. They should try to upload a YouTube video on their channel every week.

The issue is in no way related to what Oblato is doing at this stage but rather completely related to what Hough Ear Institute is doing. It appears that Hough Ear Institute is directing what is happening with the proof of concept study and not Oblato.

Obviously we know that Hough Ear Institute has told us that Oblato needs this data in order to determine whether to conduct a trial for tinnitus, however Hough Ear Institute won't submit this until they have now gotten the full funding that they supposedly need to finish the work with the study.

We simply know that Hough Ear Institute has said something one day and then contradicted or changed this another day. The study completion time frame is definitely a good example of something Hough Ear Institute has said which is contradictory.

 

[tommyd87]

Follow Up Question:

So if the study was planned to last 12 months, then why claim it would be completed in 12 months with no qualification as has happened and subsequently put up explanations and qualifications when queried?

Quite the opposite too. I am not unhappy that the the study has been started, however I am not satisfied with the fact that the time to complete the study (12 months) was stated and now it is apparent that this possibly won't be met for a range of factors which were not communicated clearly coming from the time the study commenced to now either too. This tends to be fairly poor communication of information and also actually leaves me questioning whether to donate further as well.

There is no disagreement from me that tinnitus and hearing loss can be distinct and totally independent from each other, however this is not the case with the treatment though is it? It is treating both tinnitus and hearing loss is it not? So why wouldn't it be relevant and reasonable to assume if you have donated to either hearing loss or to tinnitus that the funds could get used on this?

There tends to be some fairly confusing information being released by Hough Ear Institute and some clearly contradictory claims being made which is leaving some confused.

Reply from Hough Ear Institute:

First off, sorry for any miscommunication. Our position has always been that the study was planned to last 12 months and it would start as soon as it was funded. If you understood it differently, or if we implied otherwise - then I'm sorry.

Your concern over whether the study will be done in 12 months puzzles me a bit though. You appear to be upset over something that "might occur." True COVID has had a lot of challenges for everyone's research and it might still have an effect on this - but to get upset over it before there is a delay is, in my opinion, premature. If it gets delayed because of COVID you have every right to be upset. However even then, I can't see how you can hold us responsible for a global pandemic NO ONE anticipated.

Regarding funding for tinnitus and hearing loss research. My previous response as well as several posts and videos show how the FDA works. If you are unfamiliar with that, I suggest checking them out. Additionally, if we raise money for tinnitus, we can't ethically go and use it for hearing loss, or for corporate expenses, etc.

Consider this, the FDA does a Phase II trial for hearing loss for the pill. The subjects they gather have hearing loss at certain frequencies at certain thresholds. In the end, the pill demonstrated to be effective in treating hearing loss. Because it treated hearing loss does not mean it will be effective for tinnitus. We can't say it is effective until it is tested. That's the reason the money can't go to both. It has to go to research for hearing loss, tinnitus, Meniere's disease, cochlear implant trauma, ototoxicity, etc.

Again sorry for any miscommunication. If you would like, you can DM us here with your email. We can further the conversation there and you can show us exactly where we have been confusing and or contradictory.

We appreciate your time and support.

 

[frpp]

Follow Up Question:

Reply from Hough Ear Institute:

Trash company.

 

[annV]

This is about NAC/HPN-07 which is the same thing as the pill treatment being investigated by Hough Ear Institute.

In light of the prevalence and multi-site manifestations of blast-induced histopathological abnormalities, it is remarkable that NAC/HPN-07-treatment significantly normalized the aberrant biomarker expression patterns in the auditory system, suggesting that this treatment strategy can reduce, or perhaps reverse, both primary neurodegeneration and excitotoxic trauma in cochleae and prevent or attenuate maladaptive neural plasticity in central auditory pathways.

Link:
Electrophysiological assessment and pharmacological treatment of blast-induced tinnitus​

 

[tommyd87]

This is about NAC/HPN-07 which is the same thing as the pill treatment being investigated by Hough Ear Institute.

In light of the prevalence and multi-site manifestations of blast-induced histopathological abnormalities, it is remarkable that NAC/HPN-07-treatment significantly normalized the aberrant biomarker expression patterns in the auditory system, suggesting that this treatment strategy can reduce, or perhaps reverse, both primary neurodegeneration and excitotoxic trauma in cochleae and prevent or attenuate maladaptive neural plasticity in central auditory pathways.

Link:
Electrophysiological assessment and pharmacological treatment of blast-induced tinnitus​

This is their pill properties being tested in lab, probably as a part of the proof of concept study that they are doing.

 

[weab00]

This is about NAC/HPN-07 which is the same thing as the pill treatment being investigated by Hough Ear Institute.

In light of the prevalence and multi-site manifestations of blast-induced histopathological abnormalities, it is remarkable that NAC/HPN-07-treatment significantly normalized the aberrant biomarker expression patterns in the auditory system, suggesting that this treatment strategy can reduce, or perhaps reverse, both primary neurodegeneration and excitotoxic trauma in cochleae and prevent or attenuate maladaptive neural plasticity in central auditory pathways.

Link:
Electrophysiological assessment and pharmacological treatment of blast-induced tinnitus​

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=US

$318.00/25 mg, at least 21,000 mg required for a human dosing. So $267,120 to do this on your own.

 

[GBB]

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=US

$318.00/25 mg, at least 21,000 mg required for a human dosing. So $267,120 to do this on your own.

Ya but Chinese labs. Sigma-Aldrich won't even sell to individuals.

 

[Watasha]

Trash company.

They are nice enough to come to this site. That's more than could be said for other entities.

 

[weab00]

Ya but Chinese labs. Sigma-Aldrich won't even sell to individuals.

Just hypothetically.

 

[Drachen]

https://www.sigmaaldrich.com/catalog/product/sigma/sml2163?lang=en&region=US

$318.00/25 mg, at least 21,000 mg required for a human dosing. So $267,120 to do this on your own.

So like, assuming an optimistic future where the Hough Ear Institute Pill goes through clinical trials and such and gets on market, is a course of treatment going to be prohibitively expensive like this?

I don't understand the economics behind pharma, so I assume there's some method for greatly reducing that price, but how much so? Because that figure right there is just... yikes.

 

[weab00]

So like, assuming an optimistic future where the Hough Ear Institute Pill goes through clinical trials and such and gets on market, is a course of treatment going to be prohibitively expensive like this?

I don't understand the economics behind pharma, so I assume there's some method for greatly reducing that price, but how much so? Because that figure right there is just... yikes.

Definitely. It'd probably be like $4k. They get bulk deals & negotiations, I suppose it's a lot cheaper to mass produce a drug.

 

[tommyd87]

So like, assuming an optimistic future where the Hough Ear Institute Pill goes through clinical trials and such and gets on market, is a course of treatment going to be prohibitively expensive like this?

I don't understand the economics behind pharma, so I assume there's some method for greatly reducing that price, but how much so? Because that figure right there is just... yikes.

They have quoted that the treatment cost would be about the cost of a hearing aid.

At this stage, I think that would be a reasonable and plausible price point. We do not know exactly where that price point sits since it could be the cost of an expensive one (so $5K) or a cheap one (so $1K). It definitely won't be anywhere near the cost of what @weab00 noted of $267,120 or whatever it was.

 

[Watasha]

Definitely. It'd probably be like $4k. They get bulk deals & negotiations, I suppose it's a lot cheaper to mass produce a drug.

In the meantime, hop on over to this thread and take 3 minutes to email the American Tinnitus Association and ask them to use their recently received $2.7M bequest on funding research instead of call lines.

Call to Action: Contact the ATA Right Now — 3 Minutes to Make a Difference

The more paths for treatment, the more affordable it can be!

 

[Sam99]

They have quoted that the treatment cost would be about the cost of a hearing aid.

At this stage, I think that would be a reasonable and plausible price point. We do not know exactly where that price point sits since it could be the cost of an expensive one (so $5K) or a cheap one (so $1K). It definitely won't be anywhere near the cost of what @weab00 noted of $267,120 or whatever it was.

@weab00 was calculating price according to the price of HPN-07 on Sigma-Aldrich. It's not surprising considering they are notoriously known for their absurd pricing, I read somewhere they add up to 60x markup and even more on the chemicals they sell.

So it will be much cheaper, although it will cost several thousands still.

 

[Sam99]

I am not sure if this was posted before or not.

This paper suggests that cochlear synaptopathy is more likely responsible for generation of tinnitus and hyperacusis rather than the death of sensory hearing cells.

If that's the case then Hough Ear Institute's Pill or OTO-413 are more likely to reduce or eliminate tinnitus & hyperacusis than FX-322, at least in those with normal audiograms.

@FGG

Is noise-induced cochlear neuropathy key to the generation of hyperacusis or tinnitus?

 

[FGG]

I am not sure if this was posted before or not.

This paper suggests that cochlear synaptopathy is more likely responsible for generation of tinnitus and hyperacusis rather than the death of sensory hearing cells.

If that's the case then Hough Ear Institute's Pill or OTO-413 are more likely to reduce or eliminate tinnitus & hyperacusis than FX-322, at least in those with normal audiograms.

@FGG

Is noise-induced cochlear neuropathy key to the generation of hyperacusis or tinnitus?

It's not one thing. If it was always cochlear synaptopathy, hydrops wouldn't cause tinnitus. Neither would middle ear disease.

Anything that interferes with the hearing signal will cause "phantom cochlea" i.e. tinnitus.

It's not one structure.

But cochlear synaptopathy is probably the most common cause in noise induced because the synapses are more sensitive to noise but it's not the only cause and a lot of people will have mixed hair cell loss and synaptopathy.

 

[Artemis2K]

So like, assuming an optimistic future where the Hough Ear Institute Pill goes through clinical trials and such and gets on market, is a course of treatment going to be prohibitively expensive like this?

I don't understand the economics behind pharma, so I assume there's some method for greatly reducing that price, but how much so? Because that figure right there is just... yikes.

Mass producing, making something widely available, would normally reduce the price significantly, especially if an item is highly produced by multiple manufacturers (therefore reducing manufacturing price by competition) and sold by multiple companies (therefore reducing sales price by competition.) The less unique something is, the less valuable it is. If everyone competes for the demand & value of the item, then it's eventually everywhere and worth a lot less over time, and brand recognized value becomes more crucial. This is why you'd find brands selling the exact same item from the same Chinese manufacturer on Amazon, but the brands with the largest recognition (therefore largest presumed trustworthiness) selling at a higher price... even if other sellers are selling the same thing for cheap.

Unfortunately, the drug industry is not as simple, because (as far as I understand it) patents/IP laws AND government regulation can determine the availability and price of a product, so it's hard for me to say.

 

[reggie green]

Hs anyone done a follow up with Hough Ear Institute? They seem quiet.

 

[weab00]

Hs anyone done a follow up with Hough Ear Institute? They seem quiet.

Probably going the way of Audion lol.

 

[wwtsai]

Hs anyone done a follow up with Hough Ear Institute? They seem quiet.

Someone on the Hough Ear Institute Facebook page asked a week ago and got the following response:

"Rest assured that we're working hard to get treatments to the clinic! FDA approval takes time though, so hold on to hope! Our pill is in the planning stage of phase 2 trials and the injection is in earlier phases. We won't stop until there are viable options for those who are suffering."
​

Thing is, on their webpage, they state that they need to conduct a proof of concept study before going into Phase 2 clinicals for tinnitus. Does that mean they've already conducted the proof of concept study? They could also be referring to Phase 2 for hearing loss as that is a different indication.

 

[reggie green]

Probably going the way of Audion lol.

Huh, what do you mean?

 

[rid0871]

Hough Ear Institute is nothing but a scam... Why talk about them...

 

[Jrblovsky]

Hough Ear Institute is nothing but a scam...

Hopefully not.

 

[Artemis2K]

Hough Ear Institute is nothing but a scam... Why talk about them...

...Their pill isn't even on the market yet. I think it's quite too early to call it that, especially since they really are trying and want to get government approval and funding.

 

[reggie green]

I gave Hough Ear Institute a call. I spoke to a recording. No one called back. I don't know. Mmmmh.

 

[Rb86]

Hough Ear Institute is not a scam. I've emailed tons with them. I think they're a non-profit without the financial backing like Frequency Therapeutics has, and so their moves take much longer. As annoying as it is. At least it's not as retarded as that University of Michigan thing with Dr. Susan Shore. That is blatantly stupid.

 

[Jrblovsky]

I spoke to these guys today. They said it will be one or two years before the injectable drug starts clinical trials.