hence the hearing aids. Tubing Depends on is part of a custom earmould, supplied with the hearing and has gone through earmould) aid. conformity assessment of the hearing aid. Acoustical Tubing supplied separately can Classification Regulation Depends on tubing be classified separately if 1.2 follows the follows the hearing (for earmoulds or tubing can be used with “any” device device aid supplied type of hearing aid. separately) Examples are FM equipment, ALD N/A IR equipment, teleloop (assistive Not a listening device (PSAP systems, radio, TV. Depending 2. medical excluding regulations on the intended use, ALDs can device Group hearing aid ?) be accessories to medical or group auditory devices or not. trainer.) A group hearing aid or group auditory trainer is EPF a hearing aid that is intended for use in communicating simultaneously with one ALD or more listeners having (assistive hearing impairment. 510k listening device 2.1 Class 2 874.3320 The device is used with required Group hearing aid or group auditory an associated trainer.) transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either
supplied with earmould) Depends on the hearing aid. hence the hearing aids. Tubing is part of a custom earmould, and has gone through conformity assessment of the hearing aid. 1.2 Acoustical tubing (for earmoulds or supplied separately) Classification follows the device Regulation follows device Depends on the hearing aid Tubing supplied separately can be classified separately if tubing can be used with “any” type of hearing aid. 2. ALD (assistive listening device excluding Group hearing aid or group auditory trainer.) Not a medical device N/A (PSAP regulations ?) Examples are FM equipment, IR equipment, teleloop systems, radio, TV. Depending on the intended use, ALDs can be accessories to medical devices or not. 2.1 ALD (assistive listening device Group hearing aid or group auditory trainer.) Class 2 874.3320 A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either EPF 510k required
Classification-Document-v14.4.docx