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The Nuance Audio Hearing Aid Software is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The software utilizes a preset fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.

The Nuance Audio Hearing Aid Software is a software-only device that is comprised of a pair of software modules which operate on two separate required products: (1) Nuance Audio Application on a compatible iOS or Android product, and (2) Nuance Audio Hearing Aid Software Firmware (FW) using the compatible wearable electronic computing platform, the Nuance Audio Glasses (smart glasses). The Nuance Audio Hearing Aid Software amplifies sounds for adult users, 18 years of age and older, who have a perceived mild to moderate hearing loss. The Nuance Audio™ App, iOS or Android mobile application, quides the user through the initial onboarding and set up process providing step-by-step instructions to guide the users can select from four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied. The user may also adjust the overall volume, noise reduction, and microphone directionality. The device incorporates a feedback control algorithm to reduce the likelihood of the user experiencing acoustic feedback. The same amplification settings will be applied to both the left and right ear. This device can be fitted by a user without assistance from a hearing healthcare professional.