Medical device certification process needs to be adapted

The FDA clearance is for the whole system: the software, the earbuds, and the Apple devices themselves. This means Otoharmonics will need to get additional clearances if they want to develop future versions for Android or other platforms, or even for subsequent generations of Apple products.

This simply isn’t feasible. Medical device certification needs to be revised. Only major algorithm revisions should prompt the need for recertification.