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 r

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.