72e1de5a-3d48-45dd-a244-b166955d1a79UpdatePublished22025-08-202025-06-25In Commercial Distribution00842318196330PrimaryGS1AUDIOSYNCAUDIOSYNC INTRIGUE AI 12 CIC NW055461479Starkey Laboratories, Inc.1truefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseMR Unsafetruefalse41209Air-conduction hearing aid, canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.falseActive38049Tinnitus 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.falseActiveKLWMasker, tinnitusESDHearing Aid, Air-Conduction, PrescriptionStorage Environment HumidityStorage Environment Temperaturefalsefalse