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The Self-Fitting hearing aids are intended to amplify sound for individuals 18 years of age or older with to moderate hearing impairment. They are adjusted by the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

Per 21 CFR 874.3325, a self-fitting wireless air conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with domes. Self-Fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow the user to adjust volume setting and customize the hearing mode program.