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The IQbuds 2 PRO Hearing Aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for over the counter sale and use without the assistance of a hearing care professional.

The Nuheara IQbuds 2 PRO Hearing Aid (Model NU320) is a self-fitting wireless air conduction hearing aid (§ 874.3325) consisting of the hearing aids with Ear Tips. Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton. The device is indicated for over-the-counter sale. The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.