aScreen - Otoacoustic emission system, battery-powered

Intended purpose

The aScreen system is intended for hearing screening in patients of all ages including newborns. The aScreen system can be used in healthcare and hearing diagnostic centres, maternity centres, ambulatory-care and testing laboratories of research institutes. The aScreen system is to be used by trained personnel only, such as audiologists, ear-nose-throat (ENT) doctors, paediatricians, 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.