Tinnitus usually being an outcome/symptom of hearing loss is the view that I also share. It seems quite obvious that FX-322 helps with hair cell restoration. Right now it looks like synapses might also get treated by FX-322. The question is we don't know how much synapses will benefit from FX-322 at this time.Tinnitus is a symptom of hearing loss, whether it's NIHL / SSNHL; both of which FX-322 is intended to treat.
This is why Frequency Therapeutics is measuring the high-frequency response AND the HHI / QOL survey of patients in the Phase 2A. If a correlation is made between restoring high-frequency hearing and improvements in HHI/QOL, the insurance companies will likely cover it. This same correlation may be made between TFI improvement / QOL / and restored HF hearing.
So, they don't really need a tinnitus trial. They just need ENTs/Audiologists get with the 21st century and measure the ENTIRE hearing range possible.
An ENT submitting a pre-approval for FX-322 for a patient that complains of hearing loss (and tinnitus), and shows it on an audiogram would be covered; provided the insurance company accepts that it provides a long-term improvement in QOL.
Tinnitus is a symptom. Hearing loss is still the underlying condition, regardless of frequency.
Therefore I think that if you need FX-322 for hearing loss, then it is easy to prove that you are obtaining it for its primary purpose and at the moment it is relatively clear that FX-322 has demonstrated benefit for this. Furthermore, there is a strong case to be made that if you are using FX-322 for hair cell regrowth then this should be a valid reason to get insurers to add this treatment to their list of covered treatments.
However, FX-322's benefit on synapses is not yet proven and is simply anecdotal. Proof won't be obtained until the testing outcomes are received from the current clinical trial. The fact that the synapses are being looked at as a secondary outcome indicates that this treatment need could be refused and/or deliberately overlooked by insurers.
Subsequently I would also note that it may be entirely possible that insurers refuse to cover FX-322 and associated treatments entirely on the basis that they use the same sort of ruling as they do with the hearing aids now and/or they simply just decide not to actually cover it.
I still think that a top priority for Frequency Therapeutics is to get this treatment covered. Consequently it would not be surprising seeing Frequency Therapeutics take this back through the trial phases once more to cover it for other indications like synapse growth should it be deemed that this turns out to be necessary to get FX-322 covered for all possible indications that it can be used for. This way Frequency Therapeutics won't be delaying people from obtaining FX-322 who either can get it initially for hearing loss or obviously those who would pay for out-of-pocket off-label. Frequency Therapeutics would then be doing the right thing by their customers and also their stakeholders since ultimately this should mean that there is a bigger uptake and bigger sales because more people will be able to get it as they won't need to fork out cash to pay for FX-322.