As the hearing aids used in your project would fall under the category of regulated medical devices (as they would be in section 201(h) of the FD&C Act and cleared as already in the market) and as the developed app serves as an accessory to the hearing aid by assisting in training it would be recognized as a Mobile Medical Application regulated by FDA.
Such a device would fall under the category of Software Functions that are the focus of FDA’s regulatory oversight according to Appendix C of guidance document "Policy for Device Software Functions and Mobile Medical Applications". This app would fall under the sub-category of "Software functions that are used to calibrate hearing aids and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid".
App-based treatment options for psychological conditions have seen significant growth due to the Covid 19 pandemic. And so, I would like to mention an app known as Somryst. This app is the only prescription digital therapeutic for treating chronic insomnia in patients. It works by providing cognitive behavioral therapy to improve thoughts and behaviors.
If your app does in fact retrain auditory cues, then I believe the capstone project would be classified as a medical mobile app. The number of FDA-cleared or approved mobile medical apps has definitely grown and has been created for a variety of applications. In light of the ongoing pandemic, MMAs can become especially helpful for patients to manage their conditions because they may not have frequent or immediate access to their health care providers. The FDA has a regularly updated list of medical mobile apps that they have cleared or approved ( https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-premarket-submissions-include-mmas-cleared-or-approved-fda) but the one that I found interesting is called "Scientific Intake." It was cleared by the FDA in 2017 and its a medical device designed for use with an accompanying app. The device itself is a removable retainer that helps to slow your eating and is intended to assist in weight management and the app helps you manage and keep track of your eating habits, caloric intake, weight loss, etc. when using the device.
When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure.
Moreover, the FDA has regulation for apps that are considered "mobile medical apps". The FDA says that "mobile medical apps" is a mobile app that is intended "to be used as an accessory to a regulated medical device" or "to transform a mobile platform into a regulated medical device".For my senior capstone project, my team and I developed an application that is used by people with hearing aids to retrain their auditory cues. Is this app considered a "mobile medical apps"? Why or why not? Give an example of a "mobile medical app" or if you have experience using a mobile medical app regulated by FDA?
Reference:
http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps") or on general-purpose computing platforms. Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms, the FDA is issuing this guidance document to clarify the subset of software functions to which the FDA intends to apply its authority.
