Audio-Smart - Otoacoustic emission system, battery-powered

Intended purpose

· Hearing screening, including newborns (configurations 1-4). · Detection of hearing loss degree (configurations 1, 3, 4). · Detection of electrophysiological threshold of hearing (with ABR using Jewett V marker) (configurations 1, 4). · Middle ear and Eustachian tube disorders (configurations 3, 4, 5). The Audio-SMART system can be used in healthcare and hearing diagnostic centers, maternity centers, ambulatory-care and neurosurgery clinics, testing laboratories of research institutes. The Audio-SMART system is to be used by trained personnel only, such as audiologists, ear-nose-throat (ENT) doctors, pediatricians, and other hearing health care professionals and audiologically trained technicians. The system should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. The Audio-SMART system can be used to diagnose hearing disorders in patients of all ages. When performing the Eustachian tube function (ETF) test, patient should understand the instructions and perform the maneuvers to obtain reliable results.