I disagree and feel your application is more than a simple mobile medical app, I would consider it a rehabilitation device (conveniently packaged as an app on your phone, ipad, etc.). (I am expanding on Hiren’s post). In retraining auditory cues, your application assumes the role of a physical therapist (or, in this case, an auditory therapist) and as such is a stand-alone medical device. According to the FDA’s definition (and personal experiences), a mobile medical app only records and reports and some other, substantial medical device then does the regulating or performs the therapy, i.e. the app itself has no role in the actual therapeutic process. However, from what you have described, your application has a role because it does the retraining/rehabilitating of a user’s deficit auditory cues. As such, I cannot see your application being used without the guidance of a trained doctor or professional. That is, the user would not experience the full benefit of the application without properly, extensively knowing how to use it. My entire argument lies on the basis that deficit auditory-cues-identifying-abilities can be considered a real handicap. If they are not a real, rehabilitation requiring problem and/or your application’s aim is simply to sharpen auditory cues such as an app that increases cognitive function (“brainpower”) like Lumosity, then sure, consider it a mobile medical app.