AM-101 TACTT1 Results Released

[Erlend]

I got the impression that his delivery system was going to be some form of permanent implant in the ear... doesn't sound too much fun on the face of it

I hope he's OK, however

"Non-invasive" was the term he kept using, I think he was talking about a temporary straw in the eustachain tube

 

[Markku]

Our device will deliver drugs to the inner ear through a nearly invisible catheter passing through the ear canal to deposit drugs at the access point to the sensory cells of the ear. The drugs will be delivered using a miniature pump that hangs behind the ear. The unique aspect of our system is the patent pending ear canal bone anchor (ECBA), which is the attachment point for the catheter as it passes through the ear canal. Its affixation to bone with four tiny, easily deployable metal pins assures the long-term stability of the entire system and protects delicate ear structures from transmission of external forces.

http://www.resonance-med.com/our-solution/

 

[Erlend]

Our device will deliver drugs to the inner ear through a nearly invisible catheter passing through the ear canal to deposit drugs at the access point to the sensory cells of the ear. The drugs will be delivered using a miniature pump that hangs behind the ear. The unique aspect of our system is the patent pending ear canal bone anchor (ECBA), which is the attachment point for the catheter as it passes through the ear canal. Its affixation to bone with four tiny, easily deployable metal pins assures the long-term stability of the entire system and protects delicate ear structures from transmission of external forces.

http://www.resonance-med.com/our-solution/

So it *is* something you have to wear? Or maybe this is dependent on the drug. Maybe wear it one week or something for AM101?

 

[Hudson]

So it *is* something you have to wear? Or maybe this is dependent on the drug. Maybe wear it one week or something for AM101?

That has not been established yet. AM-101 is being developed in clinical trials to be delivered using intratympanic injections.

Thomas Meyer outlined that pretty thoroughly in this paper:

http://www.noiseandhealth.org/artic...me=15;issue=63;spage=83;epage=90;aulast=Meyer

I believe @ResonanceCEO's drug delivery device could be for any drugs that make it to the market for inner ear disorders in the upcoming years. As far as specific plans between the two entities, I have not read anything to suggest that Auris is collaborating with a manufacturer of a delivery company. I could be wrong though.

 

[Erlend]

Bur ResonanceCEO would just make delivery of drugs to the inner ear slightly easier (which in the medical world is huge of course)?

I mean, AM101 wouldn't be a completely different treatment with ResonanceCEO's device?

Having a clean surgical whole in your ear drum is safe. It is normal that it bursts during childhood and stuff anyways, and grows back. I'm not nervous for the AM101. I have all my hope invested in this treatment.

 

[LadyDi]

depends on where you live but it should be cheap, i guess it shouldn't cost more than maybe 60€ it's just gel

I hope you are right. But I won't be surprised if it ends up being super expensive, at least in the beginning in the U.S. Big Pharma has a way of really jacking up the price on treatments with no competitors and that patients are desperate for.

 

[Erlend]

When I called Auris Medical in September and asked: When will this be available to the public?

The lady said worst case scenario; 3 years

Which gives us Summer 2015

Am101 is said to provide an avarage of 50% reduction people's perception of subjective tinnitus. They have also said that they have no reason to believe that it won't work for chronic sufferers.

Really you guys... I am stoked, because rational conclusion based on hard facts here mean that many of us might have T reduced by 50% only 3 years from now.

 

[NeoM]

When I called Auris Medical in September and asked: When will this be available to the public?

The lady said worst case scenario; 3 years

Which gives us Summer 2015

Am101 is said to provide an avarage of 50% reduction people's perception of subjective tinnitus. They have also said that they have no reason to believe that it won't work for chronic sufferers.

Really you guys... I am stoked, because rational conclusion based on hard facts here mean that many of us might have T reduced by 50% only 3 years from now.

Wow, that lady must be pretty confident it will pass the safety requirements and anything else it has to demonstrate.

I look forward to seeing what the post-acute studies show. Especially for those in the later months 10-12 months.

 

[Jake]

@Erlend I think I speak for all of us when I say that I REALLY hope you're right

 

[Kimbo Slice]

Please give us the option to take a pill. I cringe at the thought. I don't mind a needle going into my arm but for the love of god please dont make it the eardrum.

 

[EddyLee]

I am willing to be shot at anywhere include my private part if that's what it takes to reduce my T

 

[Hudson]

I am willing to be shot at anywhere include my private part if that's what it takes to reduce my T

We have a champion here ladies and gentlemen.

 

[nills]

50% ?? I`ll take two shots please

 

[mick]

Our device will deliver drugs to the inner ear through a nearly invisible catheter passing through the ear canal to deposit drugs at the access point to the sensory cells of the ear. The drugs will be delivered using a miniature pump that hangs behind the ear. The unique aspect of our system is the patent pending ear canal bone anchor (ECBA), which is the attachment point for the catheter as it passes through the ear canal. Its affixation to bone with four tiny, easily deployable metal pins assures the long-term stability of the entire system and protects delicate ear structures from transmission of external forces.

@ResonanceCEO,

Could you elaborate on what "passes through the ear canal" means? I would assume this still means going through the ear drum. Is that correct?

mick

 

[Markku]

@ResonanceCEO,

Could you elaborate on what "passes through the ear canal" means? I would assume this still means going through the ear drum. Is that correct?

mick

I'm not him, but yes, you are correct in your assumption.

Read more here: http://www.resonance-med.com/supporting-evidence/

(Starting from "The RMT System – (concept and implantation)")

While similar to the µCath in its delivery of agent to the RWM, the RMT system is a truly minimally invasive solution. Instead of requiring a temporo-meatal flap for exposure of the anatomy and the drilling of the ear canal wall for anchoring purposes, our system uses four small pins deployed from a central anchor into the bony portion of the ear canal just outside the tympanic membrane. This central anchor creates an immobile segment between the anchor and the middle ear space. This immobile segment serves two functions: 1) it ensures that outside forces cannot be transmitted into the middle and inner ear; 2) the sensitive portions of the system cannot be pulled from their proper positions. In fact, if the system were to be pulled from the outside with enough force, the pump and outer catheter would simply detach without damaging any of the delicate structures of the ear. After the anchor is deployed, a small fiberoptic endoscope is used to visualize the middle ear structures. Once the RWM is identified and cleared of false membranes, a small catheter is directed over the endoscope and is guided into position at the round window membrane. The inner catheter is then secured to the anchor, and finally, the outer catheter and pump are attached to the anchor.

 

[Tenna]

I plan on being habituated at that time, cant say I'd deny one though just only the home injections, wouldnt put my ears in my own hands again Does anyone know if it's possible post treatment going to concerts again? If the effect of the gel remains stable, keeps on working, or if another injection is possible?

 

[Erlend]

I plan on being habituated at that time, cant say I'd deny one though just only the home injections, wouldnt put my ears in my own hands again Does anyone know if it's possible post treatment going to concerts again? If the effect of the gel remains stable, keeps on working, or if another injection is possible?

I've read that it will prevent further damage to slme degree yes. I am not going to risk it but concerts have never been a big part of my life

 

[Tenna]

I see ty! Very much wonder about that degree I wish I felt the same, one of the most awful things about the t is knowing all the musical experiences, theatre anything, that I'm missing out on, heartbreaking.
Just had a chat with a collegue who dj'ed for 27 years, suffering from nothing while taking no precautions, science ought to decipher him

 

[Markku]

I see ty! Very much wonder about that degree I wish I felt the same, one of the most awful things about the t is knowing all the musical experiences, theatre anything, that I'm missing out on, heartbreaking

Why? Can't you get some custom made quality earplugs, as you probably know, there are different filters available (up to 25dB) for them?

It's one thing to be safe around noise, but completely another over-protecting oneself and missing out on life because of tinnitus in the process.

25dB is a significant reduction and should keep one safe in many situations (using common sense of course).

But yes... I understand the fear.

 

[Tenna]

Got a pair with -25dB on their way =)!
Being overprotective is greatly counterproductive I agree, it's just very hard for me to draw the line of common sense at such club-loud noise exposure. I don't even drink nor do drugs -.- then I got tinnitus lol. But in theory the pair should keep me safe for hours I guess

 

[James White]

Got a pair with -25dB on their way =)!
Being overprotective is greatly counterproductive I agree, it's just very hard for me to draw the line of common sense at such club-loud noise exposure. I don't even drink nor do drugs -.- then I got tinnitus lol. But in theory the pair should keep me safe for hours I guess

I always wore musician earplugs when i was going to clubs and concerts (around 100) but the tinnitus started when i wasn't wearing any (ear damage during band rehearsal, i was tweaking an amp that malfunctionned between songs) so i guess i could go to concerts with earprotection but i'm at the same point as you. What bugs me the most is that concerts would be great at 90db but people want big sound so it's 105db

 

[Hudson]

I plan on being habituated at that time, cant say I'd deny one though just only the home injections, wouldnt put my ears in my own hands again Does anyone know if it's possible post treatment going to concerts again? If the effect of the gel remains stable, keeps on working, or if another injection is possible?

I would say "don't look a gift horse in the mouth". By all means, go to concerts if you really enjoy doing it. Just wear hearing protection! I went to many multiple live shows, concerts, fireworks shows, days shooting at the range, etc. over the years after I have had tinnitus. The only time my tinnitus has ever been affected was when I was in a a loud bar without protection. If AM-101 does reach market approval and it helps tinnitus sufferers to a good extent, that will be great! What I don't think it will do is be a magical cure-all. It may tame your tinnitus, but the underlying damage to the auditory system that caused tinnitus in the first place may still exist. This is why it is important to continue to use hearing protection. I would suggest that you continue to use ear plugs around any excessive noise levels until the day comes when they can regenerate hair cells. Which is a "few" years off to say the least.

 

[Johno]

I plan on being habituated at that time, cant say I'd deny one though just only the home injections, wouldnt put my ears in my own hands again Does anyone know if it's possible post treatment going to concerts again? If the effect of the gel remains stable, keeps on working, or if another injection is possible?

Concerts? Would you risk it? Maybe - with earplugs. AM-101 (i hope) reduce or destroy Tinnitus in our ears, but can not repair damaged hair cells. This will be possible only with gene therapy or stem cells therapy. After absloving this procedures (in the future, i hope near future) you can go to the concerts like before and get T again. Be carefull for rest of you life!

 

[NeoM]

I would say "don't look a gift horse in the mouth". By all means, go to concerts if you really enjoy doing it. Just wear hearing protection! I went to many multiple live shows, concerts, fireworks shows, days shooting at the range, etc. over the years after I have had tinnitus. The only time my tinnitus has ever been affected was when I was in a a loud bar without protection. If AM-101 does reach market approval and it helps tinnitus sufferers to a good extent, that will be great! What I don't think it will do is be a magical cure-all. It may tame your tinnitus, but the underlying damage to the auditory system that caused tinnitus in the first place may still exist. This is why it is important to continue to use hearing protection. I would suggest that you continue to use ear plugs around any excessive noise levels until the day comes when they can regenerate hair cells. Which is a "few" years off to say the least.

Ahh...hair cell regeneration. I think it would be awesome for that to happen in the next 10-20 years. That might show we're all going to make it.

 

[Jake]

Even if AM-101 doesn't cure or reduce tinnitus for chronic sufferers, do you think that it would be able to prevent it from getting worse? In my mind, that's half the battle. If the underlying possibility of it progressing to catastrophic levels was eliminated, sign me up. I'll take the injections in a heartbeat.

 

[Johno]

Even if AM-101 doesn't cure or reduce tinnitus for chronic sufferers, do you think that it would be able to prevent it from getting worse? In my mind, that's half the battle. If the underlying possibility of it progressing to catastrophic levels was eliminated, sign me up. I'll take the injections in a heartbeat.

If tinnitus comes from damaged cochlea, in my opinion, AM101 may help even it turns to chronic. Because they dont surely know, if is noise/drug induced tinnitus memorable in auditory cortex by time. If tinnitus is induced by other way (scull fracture - auditory nerve damage, or damage of auditory center in brain, acustic neuroma, spine nerves damage..., Am101 certainly can not help in this cases.) I hope and i am nearly sure, AM101 will help to chronic sufferers with (only) destroyed hair cells too.

 

[Erlend]

If tinnitus comes from damaged cochlea, in my opinion, AM101 may help even it turns to chronic. Because they dont surely know, if is noise/drug induced tinnitus memorable in auditory cortex by time. If tinnitus is induced by other way (scull fracture - auditory nerve damage, or damage of auditory center in brain, acustic neuroma, spine nerves damage..., Am101 certainly can not help in this cases.) I hope and i am nearly sure, AM101 will help to chronic sufferers with (only) destroyed hair cells too.

Audiotory nerve damage, can that happen after concert? :S

Also, I don't think it get's "stuck" like memory. People work in places with high pitched sounds for 8 hours a day for years without getting this sound "stuck".

 

[Johno]

Audiotory nerve damage, can that happen after concert? :S

Also, I don't think it get's "stuck" like memory. People work in places with high pitched sounds for 8 hours a day for years without getting this sound "stuck".

No, main auditory nerve can not take damage after concert. I dont believe, than tinnitus is memorable too because this situation has not natural point.

 

[demi]

Hoping for the day they figure it all out, any sort of treatment would be amazing.

 

[t-man]

No, main auditory nerve can not take damage after concert. I dont believe, than tinnitus is memorable too because this situation has not natural point.

Actually, I do believe the audio nerve can be damaged from noise. The nerve can be physically burned by a large amount of stimulation from the cochlea. It's like running a larger than normal current through a wire; the shielding burns off, but in the nerves case, this shielding will actually grow back. But in many cases the nerve is damaged and that's where the lack of signal from the cochlea can be.