I agree with pretty much everyone on this post regarding the fact that your device would be considered a mobile medical app. The fact that your capstone project actually served as a method to TRAIN users to hear auditory cues implies that it is aiding the person in a way. The FDA has a very intricate definition for a medical device but, I am going to take the parts that are relevant to your device. So, a medical device is “an instrument, apparatus, machine etc.. that is intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention of a disease”. I think that latter part of that sentence really defines your device as it actually is trying to treat, in a sense, individuals with hearing problems. I looked at some other apps online and I found this really interesting one: AgaMatrix’s iPhone Glucose Meter. This meter is like your typical glucose meter but it can actually hook up into your phone and shows you a detailed analysis of its findings. This can then be sent to your doctor in real-time. Really interesting stuff.

Just curious: Did you guys follow up on your project and try to get a patent? If so what are some of the regulatory concerns that you had to look into?

References:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
http://www.mobihealthnews.com/15137/fda-clears-agamatrixs-iphone-glucose-meter