You are missing my point - OTC is simply over the counter, it is...

You are missing my point - OTC is simply over the counter, it is FDA approval that is the key ingredient. In Europe, there is NO OTC requirement, where the overwhelming majority of distribution and retail action took place with no sales uptake. JuieM keeps stating OTC is a gamechanger, OTC only relates to the USA. Let us be very clear on this, the big swing in Nuheara's plans in Europe came with NAL algorithims, OTC as i keep repeating, is only allowing the product to be sold as a hearing aid, it does not change the product nor the intended market, which has always been mild hearing loss. Lets be clear Sonava, Specsavers, Hidden Hearing etc were NOT waiting on any OTC clearance. Thse organisations were all looking for an entry level pre-hearing aid product to fill a gap in the market and a lead into a hearing aid device as someone has previously mentioned on this thread. They were not looking for a hearing aid as hearing aids are where they make the big dollars. What they were after was something to sell a customer to get a sale when the customer did not have a requirement for a hearing aid.

If you ask yourself why, the answer is that the head audiologist primarily owns the practice, under the banner of the main corporation ( such as Specsavers as an example as Stu has been checking out ) As the audiologist is interested in profitability and customer retention, then the audiologist is going to sell a hearing aid, as they makie money on batteries, re-tuning, accessories, cleaning etc etc. Therin lies the problem. They woould only sell Nuheara IF the cutomer had no requirement for a hearing aid, so Nuheara becomes the goto product IF the customer has no requirement for a hearing aid OR cannot afford one.

So as i said on my post above, i am excited to see for the first time on an annoucement the introduction of ENT distribution, which people with limited funds ( ie OTC customers ) will go to as a port of call to check their hearing, should they not want to go to an audiologist. IF the ENT recommends Nuheara, THEN you would see some numbers starting to appear on the board, as you are bypassing the private audiologist practice by this method. That is why i feel a sense of excitment in reading that, as it is a clever tact and path to go down, and one that I am sure was raised before as a pathway to sales, but was perhaps ignored or not actioned.

In reality, what Nuheara should have done back then was went and got MDD clearance in Europe ( now known as MDR). This would have seen them being able to classify the device in Europe as a hearing aid, instead of waiting for OTC in the USA to eventually transpire in the last month or two of December 2022, then they would have had both markets, and the European one a long time before to get a working model in place before the USA FDA one arrived.

But today I am more optomistic than yesterday, lets see.