In the approved countries a regulatory body has had to approve this as a medical aid. If medical aids etc did not have to be approved then things that actually hurt and kill people could be sold as medical aids.
The issue here is that this case appears to be a non damaging aid and so it looks silly to ban it. But regulations have to work otherwise they are of no use.
The issue here is either regulators in other countries are slow or in the worst case Apple has not applied for approval.
Then you still have the issue of whole-system incentives. With free software, there is no incentive to prevent OpenHearingAids from working in France, since it's provided at the user's own risk, and installed by the user themselves, who don't have to ask permission to do so. But when a company controls the process, that company is responsible for everything.
It's somewhat similar in spirit to the end-to-end encryption issue: government agencies can demand platforms hand over copies of users' messages if they have them, but they can't force platforms to have them, resulting in platforms going out of their way to not have copies of users' messages. If a platform went out of its way to not have control over the software its users run (this describes most non-Apple general computing platforms) then it can't be forced to regulate that software. If it does, it can.
Constructing sewage, the evolving history of work, and regulating hearing aids have very little in common, and apart from the last very little to do with regulators.
In the approved countries a regulatory body has had to approve this as a medical aid. If medical aids etc did not have to be approved then things that actually hurt and kill people could be sold as medical aids.
The issue here is that this case appears to be a non damaging aid and so it looks silly to ban it. But regulations have to work otherwise they are of no use.
The issue here is either regulators in other countries are slow or in the worst case Apple has not applied for approval.