Imagine That a Cure Is Found. Then What Happens :-)

Imagine... the day has arrived. Phase III was successful.

Frequency or another company did it, they found the cure to reverse hearing loss and as a consequence a majority of tinnitus cases.

(Bear with me ;-) )

What would be the implications from there?

I would think that the meds would still need to be approved by US (FDA?) and Europe separately?

Would it get fast-tracked? What does that mean?

Considering that HBOT is considered a standard treatment in some countries and not supported in others. Could the drug be available quicker in some countries than others?

Demand would be very high, so I would assume the price as well?

I could imagine that there would be waiting lists.

As there are different levels of hearing loss / tinnitus severity, some people should get priority?

It would probably take another few years before the med would be covered by health insurance companies. And perhaps only in cases of (severe) hearing loss...

In general: what would be a possible timeline after a succesful phase 3?

 

FDA has made it very clear they don't care about tinnitus, so we can't expect any special treatment. If it's a medicine of some sort like Freq fx, then it could be two and a half years. If it's a device it's probably going to be at least a few months. Most likely in the realm of 6 months.

I don't know if the FDA and european drug administration (I think that's what it's called?) have a cooperative agreement like that, but I read it's easier to get something passed over there, so we could be seeing a release over there shortly before over here. However if it's a US based company it will happen here first.

For insurance that would be complicated. If it's for hearing loss as well it might be covered, but if it's just for tinnitus it won't be, because nobody really cares about it. So maybe something like Freq fx would be covered but if it's only for >50dB loss, then there's a chance it doesn't because "mild" hearing loss isn't considered to be disabling.

 

For me I am so desperate to save my life, I would take them with no approval

People with $$$$ will get priority over the serf's.

 

I don't think that there will be a one cure fits all right away, but if the inner ear hair cells could be regrown, that would probably cover a lot of people for both deafness and/or tinnitus.

 

I am jealous of birds since they can grow damaged hair cells back.

 

I did not know that. That's amazing. It's interesting when I go on my morning walks that's the sound that stands out more than any others, the sounds of birds chirping.