23b3970d-54af-4d56-bb52-7535bd4bfc96UpdatePublished22025-08-202025-06-25In Commercial Distribution00842318198822PrimaryGS1AUDIGYAUDIGY AGXS GENESIS AI 24 MRIC R (TIER DEMO)055461479Starkey Laboratories, Inc.1truefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseMR Unsafetruefalse38049Tinnitus masking application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.falseActive47169Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.falseActiveOSMHearing Aid, Air-Conduction with Wireless Technology, PrescriptionKLWMasker, tinnitusStorage Environment HumidityStorage Environment Temperaturefalsefalse