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According to CDSCO guidelines, Hearing aid calibrator and analysis system falls under Risk Class B under ENT Devices category of Medical Devices. Intended use - A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer.. This article will give you complete information about manufacturing Hearing aid calibrator and analysis system