It would be interesting to see, I mean the argument is that my head phones don&#x27;t need FDA approval and they can damage my hearing if I turn them up too loud. But some kind of limits would be important to ensure safety.<p>And this post is a question because I don&#x27;t know the answer, so I am just guessing (a lot). I hope someone with actual experience in getting FDA approval for a medical ultrasound machine actually reads it and answers, with how much it cost and what hoops they had to jump through.