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The Tuned Self-Fitting Mobile App is a software-only mobile medical application that is intended to be used with compatible wireless air-conduction hearing aids. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Tuned Self-Fitting Mobile App utilizes a self-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 Tuned Self-Fitting Mobile App is a software-only, over the counter (OTC) medical application designed to support adults (18+) with perceived mild to moderate hearing loss. Available on both iOS and Android platforms, the app allows users to independently tune and personalize the settings of compatible wireless air-conduction hearing aids without requiring assistance from a hearing healthcare professional.

The Tuned Self-Fitting Mobile App utilizes calibrated pure-tone audiometry to conduct a self-administered hearing test and computes individualized amplification targets based on the NAL-NL2 prescription algorithm. It automatically configures connected hearing aids according to the results and enables additional fine-tuning by the user through intuitive controls for volume, frequency bands (low/mid/high), and preset sound environments such as everyday use, speech enhancement, music, and outdoor noise reduction.

The reason for this submission is to expand the use of the Tuned Mobile App, which was previously cleared under K223848 for use with the Lumen155 hearing aids (Intricon, USA), to include an additional compatible wireless air-conduction hearing aid, the NoviOne (Novidan, USA).

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