Exactly. People forget that tinnitus is a symptom and not an illness in itself, but the effects it has on a person reflects that of an illness. And so really, I'm looking for a reduction in the symptoms, not complete removal of the core issue as this could take a long time.
That's right. For me, the cold anesthetic was more uncomfortable before the injection
I was a bit nervous, but I remember as soon as the fluid would enter the insides of my ear I'd lose consciousness. But it wasn't fear/pain. I don't know why it happened; it may have been a simple reaction that I had.
This is a normal reaction to something you think is dangerous. Almost like someone telling you they have to cut off your foot. I would faint
It makes me very sad, every time I hear that a trial is only for recent cases...
I know, but maybe it will work for long term. They haven't done too many studies on it yet.
Do you have hyperacusis at all? How did they remove the Lidocaine? Microsuction? I probably need to do intratympanic injections anyway.
Zero hyperacusis. Microsuction, yes. I can see how that procedure could be somehow harmful for someone with hyperacusis. It lasts a couple of seconds, tho.
That's because the most popular theory of tinnitus says that it settles into the brain after a few months. Otonomy is playing it safe. For their Phase I trial they only allowed patients in if they'd had tinnitus for less than 6 months. In Phase I they saw no decrease in effectiveness for patients near the 6 month mark, which is why they opened up the trial to patients who've had tinnitus for up to 1 year for Phase II. If they continue to see no decrease in effectiveness I imagine they'll probably keep expanding the window.
A doctor (at least in the US), is fairly free to prescribe a treatment even if it is outside the clinical trial window. This is why we say they are "practicing medicine." If an ENT were to find out you've had tinnitus for 8 months, but the drug was only FDA approved for 6 months, I think it's highly likely that they would offer to trial treat you and find out if it helps. It's also highly likely, that with FDA approval, more parallel trials will take place to expand the scope of care.
This question will probably only be answered if and when the drug hits the market.Is it true that OTO-313 only works for new patients? I have had tinnitus for 1.5 years. Does it work out for my case?
There are many people who have experienced tinnitus for a longer time. I hope OTO-313 covers everyone.
If someone just gets something to market I think there will be a lot more investments and interest.
Yeah! If they are into profits, marketing and revenue, I'd say the long-term sufferers is what it's all about.
Otonomy is playing it safe and going by the current theory that tinnitus starts in the ear and then moves to the brain. Their drug treats the ear, so they want to avoid patients with tinnitus originating from their brain. Many people, like myself, don't believe that's how tinnitus really works. However, it's currently the most popular theory.
I'm actually surprised Otonomy / FDA would be approving of this doctor doing this video. There are specific restrictions on advertising / recruiting for clinical trials. Most importantly, because doing so can affect the outcomes of the trial adversely (ie: Placebo Effect) and patient safety. Obviously, that isn't this doctor's intention, but reading a title like "A Cure for Tinnitus?" is exactly the kind of promoting that gets patients in the mindset to be coerced to produce false outcomes if they join the trial seeking a "Cure."
Knowing full well that any of these companies will need clinics to distribute the drug it's possible he has heard anecdotes describing positive results and wants to get a leg up building an SEO presence that will become incredibly saturated if a drug like this is approved and released. We often forget that even if a drug or device is approved - getting it into clinics and training clinicians is no easy feat. The benefit these trial doctors have is knowing how to assess a patient and deliver the goods. It puts them at the front of the line if it's approved and they stand to make outsized returns - at least initially - while the rest of the interested doctors/clinics get trained.
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