classified as MD following rationale should be used. charging hearing If battery cannot be removed aids including from hearing aid it is an battery) accessory to a hearing aid Cleaning fluid is a medical Cleaning fluid device, but only if specifically (not disinfecting, to 13.1 No No clean hearing developed to clean hearing aids/earmoulds by aids etc. the user) . A general purpose disinfectant is a Specific cleaning fluids for germicide intended to disinfection process noncritical exempt from the premarket medical devices and notification procedures in equipment surfaces. A subpart E of part 807 of this Cleaning fluids general purpose chapter subject to the (that have 880.6890 I disinfectant can be used limitations in 880.9. disinfecting General function to 13.2 (general to preclean or LRJ exempt purpose disinfect hearing controls). decontaminate critical aids/earmoulds by disinfectant or semicritical medical the user) devices to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. If the cord can be removed Cord from the hearing aid, and the (includes cord 14. No No hearing aid still works as between receiver intended by the manufacturer, and Bodyworn) the cord is not an integral part
charging hearing aids including battery) classified as MD following rationale should be used. If battery cannot be removed from hearing aid it is an accessory to a hearing aid 13.1 Cleaning fluid (not disinfecting, to clean hearing aids/earmoulds by the user) No No Cleaning fluid is a medical device, but only if specifically developed to clean hearing aids etc. 13.2 Cleaning fluids (that have disinfecting function to disinfect hearing aids/earmoulds by the user) I (general controls). 880.6890 General purpose disinfectant . A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. LRJ exempt Specific cleaning fluids for disinfection exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 880.9. 14. Cord (includes cord between receiver and Bodyworn) No No If the cord can be removed from the hearing aid, and the hearing aid still works as intended by the manufacturer, the cord is not an integral part
Classification-Document-v14.4.docx