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The Bose SoundControl™ Hearing Aids is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional. Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).

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 Bose SoundControl Hearing Aids (Model BMD0012) are self-fitting wireless air conduction hearing aids consisting of the Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the Bose Hear app independently and as a system. The hearing aids are powered by a disposable size 312 zinc-air battery. The hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with open or closed domes. The hearing aids are controlled via on-board button controls and wirelessly via the Bose Hear app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.

The Bose Hearing Aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

The Bose® Hearing Aid is a user-fitted wireless air-conduction hearing aid intended for use by individuals 18 years of age and older with perceived hearing impairment. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth® using a handheld device (iOS or Android) through the Bose Hear mobile app. There is an on-device user control (in-line remote) on the right cable (attached to neckband) that allows separate control of hearing aid ("world") volume and streaming audio volume, as well as control of directional hearing aid mode. In addition to hearing aid functionality for environmental listening, the Bose Hearing Aid can be used for placing and receiving telephone calls and for streaming audio from a Bluetooth compliant mobile device that has been paired with the Bose Hearing Aid. The controls accessible through the Bose Hear mobile application and on the hearing aid are used by the user to configure parameters, settings, and listening modes.