Not exactly. A novel device has a higher bar to get clearance. If you are developing something that already exists i.e. a hearing aid then you can go the 510k route.

Every model has to go through the same rigor with design controls and get clearance through the 510k process. There is a lot of process and documentation, and as a medical device you can't just update firmware and swap components as they go end of life. And you can't just discontinue a product. When you submit for approval you have to define the lifetime of the product and how you plan to support it through that lifetime.

I imagine Apple will keep the AirPods Pro 2 around for about a decade as their hearing aid device.

That was my first thought. I've used AirPod Pros and an expensive over-ear headset, and the headset was actually worse for ANC because of my sideburns/beard and glasses. Plane rides especially highlighted this, as the low-droning engine noise penetrated the weak ear seal easier. Perhaps the fancy acoustic feedback and ear topology modeling are going to alleviate this issue, but I'm not sure that it's going to resonate with consumers because it requires product knowledge. Give me decent ANC in the base model, and very good ANC in the Pros and it's immediately understandable what I am getting.