59bf5ea8-ece7-4120-bb4b-4952d4d0d47fUpdatePublished32025-08-202018-08-27In Commercial Distribution00842318166340PrimaryGS1AUDIBELAUDIBEL DAVINCI I1000 ITEABL P2I055461479Starkey Laboratories, Inc.1truefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseMR Unsafetruefalse34672Air-conduction hearing aid, in-the-earA 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) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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 severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.falseActiveKLWMasker, tinnitusOSMHearing aid, air conduction with wireless technologyStorage Environment HumidityStorage Environment Temperaturefalsefalse