https://www.apple.com/airpods-pro/hearing-health/ says it has received FDA authorization, but doesn’t mention receiving approval from any other country’s regulatory body. It doesn’t say it’s US exclusive, though:
The Hearing Test and Hearing Aid features are expected to be available fall 2024. The Hearing Aid feature has received FDA authorization. Both features will be supported on AirPods Pro 2 with the latest firmware paired with a compatible iPhone or iPad with iOS 18 or iPadOS 18 and later and are intended for people 18 years old or older. The Hearing Aid feature will also be supported on a compatible Mac with macOS Sequoia and later. It is intended for people with perceived mild to moderate hearing loss.
The Hearing Protection feature, on the other hand, is explicitly listed as being exclusive to the US and Canada.