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→ Sound Pharma Announces Phase 3 Study Completion of SPI-1005 for the Treatment of Meniere’s Disease

New study here: Tinnitus following treatment with ultrasonic scaler

Agreed, but from my understanding, that is a direct result of the trauma itself, and it doesn't create chronic/fluctuating hydrops, correct? Very interesting to see -- from my perusal, it looks almost like a 50/50 split of Meniere's patients seeing improvement versus people seeing no...

My response to this is that both tinnitus and hyperacusis are generally a symptom of something else, which explains why they both onset together. Hyperacusis does not cause tinnitus, just as tinnitus does not cause hyperacusis; they are often caused by the same thing, most often hearing loss...

Sounds like the distortion was diplacusis! You’re lucky it eventually resolved, though I’m sorry the hearing loss remained.

Whoa whoa, when was this proven? The Phase 2b trial tested for EHF improvement, yet the announcement this week reported no improvement in secondary outcomes (in which EHF audiogram testing was included). If the drug showed efficacy in any capacity (even in improved EHF hearing thresholds), I...

I mean, sure, but unless there’s something particular about the cochlea we’ve discovered from this, to me it would still make plenty of sense to investigate higher doses. Stronger medicine typically yields a stronger response. Both of Otonomy’s and Frequency Therapeutics’ drugs have been...

Because hearing involves more than communication. Even if EHFs don’t “affect communication”, they are still involved in everyday sounds. Please put an EQ on your favorite song and brickwall out all the information above 8 kHz. While you will still be able to discern the lyrics, how does the rest...

*Easier to treat a symptom.

What if these subjects have hidden hearing loss? For example, I have a dip as narrow as about 940-980 Hz, with a tinnitus tone at 990 Hz.

Can you explain? From what I understand: 1. Certain hair cells are not intrinsically stronger than other hair cells. 2. In cases of SSNHL recovery with steroids, antivirals, etc., high frequency hearing function is less likely to be restored than lower frequency hearing function. Please...

Not to get too off topic but wouldn't an anti-inflammatory also work to reduce excess fluid? If not, why does Prednisone work so well with Meniere's patients?

Hard to say because it’s not like Ménière’s patients don’t also have SSNHL, and tinnitus from that. I’m endlessly unclear if those with Ménière’s experience tinnitus in isolation of other symptom onset (such as SSNHL). If that’s the case, then yes, maybe fluid build-up alone would cause...

Maybe a silly question, but Otonomy hasn't published their peer reviewed journal on the detailed results yet, right? (Similar to this for phase I?) We just know it failed but don't have the data yet to sift through ourselves?

Uh oh...

I wonder in a decade, when this objective measuring is hopefully widespread (from the Bionics Institute or elsewhere), if some kind of retrial of OTO-313 can be done just to see objectively if it was doing something or not. I doubt it would happen, but I'd be so curious. I think it would be...

But did we ever get evidence that extended high frequency thresholds actually improved via an EHF audiogram? Or is this just affecting synapses in that range and not actually thresholds? My understanding might be a bit off here.

This is what's so maddening to me, given we just saw this happen with FX-322. I guess it was maybe too late as Otonomy had already begun their trial design but I can't help but feel like they shot themselves in the foot if the placebo group is actually what brought them down. (Perhaps it wasn't...

Weren't the sample sizes of Phase 1 for this device and OTO-313 very similar, and didn't Phase 1 for both trials show positive results?

I thought a previous trial established no audiometric improvement of EHFs. I know we've seen some differences around 8 kHz, but I thought there was still some skepticism over what this actually was. Has there been an update?

@Sentinel, thoughts? Would love your take on this now that the cat's out of the bag.

Really great point and thanks for attaching that data chart. The one thing that’s keeping me (and I guess others) suspicious though: What do we know about how word test results can fluctuate test to test? We already know about the test/retest margin of error for PTA (of which their reported...

I hope it’s good news too, but I assume that the “full dose” trial is also due to early data suggesting that a stronger dose would yield better results. I wonder what results they were (or weren’t) getting that inspired this adjustment. That said, I do not know how much data they would have...

Were these subjects from the OTO-313 group or the placebo group?

Absolutely yes—Phase 2 results alone will take a year to be released. Then factor in the time it takes for Phase 3 to start and then the time it takes for the drug to be commercialized if all is successful. That said, Otonomy's hope is that the drug can be effective for those who have had...

Perhaps I just don’t know enough about FX-322’s mechanics, but is it accurate to say that the drug preferentially targets the extended high frequencies? Or (as I understood it previously) it seems to target the inner hair cells throughout the cochlea? A little confused, could someone clarify the...