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The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal. The Lantos 3D Ear scanner: - . provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and; - includes an expanding membrane that can be inserted and conforms to the external ear . canal when filled with an absorbing medium which enables the 3D scan and; - records and presents to the hearing professional in an image file a topology measurement . of the external ear canal

The device consists of a hand held scanner, a single patient use disposable with a silicone conforming membrane, which when in use is filled with an absorbing medium, and a laptop computer. The hand held scanner, when not in use, is placed in a docking stand. The hand held scanner is tethered to the docking stand with a custom cable. The laptop computer is mounted on the docking stand. The hand held scanner contains LED illumination, optics, a camera, a motor to move the probe tip, and a motor-driven reservoir. User Interface (UI) software screens are displayed on the laptop and the user interacts with the device via the laptop keyboard and touchpad, and control buttons on the hand held scanner, as guided by the UI screens. Image data from the patient is stored in the laptop, and may be transmitted by the user via a wireless connection. No patient identifiable data is stored in the Lantos device. A single use disposable, which includes the conforming membrane, is placed over the hand held scanner probe tip, in a manner similar to placing an ear speculum over the viewing tip of a conventional otoscope. The disposable includes a clear window over the probe tip. The probe can be used to inspect the ear canal, when inserted into the ear canal no closer than 4-5 mm from the tympanic membrane. Additionally, the disposable can be filled with an absorbing medium so the membrane conforms to the ear, to enable the 3D scanning functionality of the device. After scanning is complete, the absorbing medium drains from the disposable so that the probe and disposable can be removed from the ear canal. The topographical measurement (scan) of the ear may be transmitted and may be used in the same manner as a desktop scan of a silicone earmold impression.