influences the program setting or directly influences device) the SW parameters of the device 6. Classification of Hearing Aids according to FDA regulations No. Product Classification Regulation Definition documented Product Pre market Comment according to in FDA regulations Code approval FDA acc to regulation FDA Classification Regulation Tubing is a detachable part Acoustical 1.1 follows the follows that may affect the acoustical tubing device device properties of earmoulds, and (for earmoulds,
influences the device) program setting or directly influences the SW parameters of the device 6. Classification of Hearing Aids according to FDA regulations No. Product Classification according to FDA regulation Regulation Definition documented in FDA regulations Product Code acc to FDA Pre market approval Comment 1.1 Acoustical tubing (for earmoulds, Classification follows the device Regulation follows device Tubing is a detachable part that may affect the acoustical properties of earmoulds, and