5. Classification of Hearing Aids according to MDD 93/42/EEC No. Product Classification according to 93/42/EEC Annex IX and MEDDEV 2.4/1 Rev 9 Rule to 93/42/EEC Annex IX Accessory According to MEDDEV 2.1/1 Apr 94 Rationale for classification Product to carry CE– mark acc to 93/42/EEC? Yes/No Comment 1.1 Acoustical tubing (for earmoulds, supplied with earmould) IIa Rule 9 No No Tubing is a detachable part that may affect the acoustical properties of earmoulds, and 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 domes, supplied separately) I (Chapter 3.2) Rule 1 MEDDEV 2.1/1 Apr 94 1.2 Yes (if too small CE on accompanying document) Tubing supplied separately can be classified and CE-marked separately after a separate conformity assessment if tubing can be used with “any” type of hearing aid. If shipped in bulk no CE-mark is needed. It is considered as a raw material. 2. ALD (assistive listening device) Depends on intended use Yes/No MEDDEV 2.1/1 Apr 94 1.2 Yes Examples are FM equipment, IR equipment, teleloop systems, radio, TV. Depending on the intended use, ALDs can be accessories to medical devices or not. 3.1 Shoe (If supplied with hearing Aid) 9 No Audio shoe specifically designed for a defined hearing aid model
connection to Hearing Aid MEDDEV 2.1/1 Apr 94 1.2 5. Battery (primary cell) No No No MEDDEV 2.1/1 Apr 94 1.1g No Multipurpose product and though not an accessory according to MDD 6. Battery (rechargeable) No No No MEDDEV 2.1/1 Apr 94 1.1g No Multipurpose product and though not an accessory according to MDD 7. Battery tester No No No MEDDEV 2.1/1 Apr 94 1.1g No Multipurpose product and though not an accessory according to MDD 8. Bone Conductor IIa Rule 9 Active medical device (non-invasive active therapeutic device that administers energy and acts by converting electrical output to vibration) Yes A bone conductor directly affects the output of hearing aids, and is therefore classified as IIa. They are also sold separate from the hearing aid, and must therefore be CE marked. 9. (BTE) hearing aids IIa Rule 9 Active medical device (non-invasive active Yes
acoustic output) 11. Charger (for rechargeable batteries) No No No MEDDEV 2.1/1 Apr 94 1.1g No Multipurpose product and though not an accessory according to MDD 12 Charger (designed for charging hearing aids including battery) If MD then I If MD then Rule I+12 If MD then MEDDEV 2.1/1 Apr 94 1.2 Yes Manufacturers can decide to classify as MD or not. If classified as MD following rationale should be used. Battery chargers specifically intended for recharging hearing aid batteries are non-invasive and are active devices because they act by converting energy. 13.1 Cleaning fluid (not disinfecting, to clean hearing aids/earmoulds by the user) I Rule I Rules 2,3,4 does not apply. Yes 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) IIb Rule 15 MEDDEV 2.4/1 June 2012 Rev 9 Yes Specific cleaning fluids for disinfection invasive.
14. Cord (includes cord between receiver and Bodyworn) - No If the cord can be removed from the hearing aid, and the hearing aid works as intended by the manufacturer, the cord is not an integral part of the hearing aid. It is therefore defined as an accessory, but is - since it may be used for other purposes - not a medical device. 15. CROS unit (including microphone and a telecoil) I Rule 12 Yes MEDDEV 2.1/1 Apr 94 1.2 Yes (if too small CE on accompanying document) An option, a detachable part and hence not an integral part of the hearing aid 16. Dummy hearing aid - No Not functional, and therefore not a medical device 17.1 Earmould IIa Rule 5 Earmoulds are invasive device connected to an active device No An earmould is a detachable part that can affect safety. Custom-made earmoulds cannot be CE-marked, but must comply with the MDD, VIII- 17.2 Earmould IIa Rule 5 1.1c Earmoulds are invasive device connected to an active device Yes An earmould is a detachable part that can affect safety. Goes with II. Article 1 Part d. If size is too small CE to put on accompanying doc:s 18. Ear dome (standard e.g dome) IIa Rule 5 Earmoulds are invasive devices connected to Yes An earmould is a detachable part that can affect safety
an active device 19. Earphone (e,g used with bodyworn) IIa Rule 9 Earphone is an active device Yes An earphone directly affects the output of body worn hearing aids, and is therefore classified as IIa. It is also sold separate from the hearing aid, and must therefore be CE-marked 20. Eyeglass hearing aid (EG) IIa Rule 9 EG is an active device Yes Eyeglass hearing aids are classified as IIa 21. Eyeglass adaptor IIa Rule 9 No An option, and hence an integral part of the hearing aid 22. Ear Hook IIa Rule 9 No A detachable part, and hence an integral part of the hearing aid 23. Impression material I Rule 5 Impression material is invasive material in transient use Yes A substance that, although for temporary use, may have health and safety implications. Hence classified as I 24. In-the-ear (ITE) / custom made hearing aid IIa Rule 5 ITE/custom made hearing aids are invasive devices Yes ITE /custom made hearing aids are classified as IIa. Faceplates should be CE-marked. This refers to Article 1 (d) definitions of custom made devices second section stating “Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices” 25. ITE assembly In-the-ear Custom 1.1c No If an operator assembles ITEs deviating from an approved
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
is not an integral part of the hearing aid. It is therefore defined as an accessory. It is specifically intended by the manufacturer of the accessory to be used together with a Medical Device 4.1 WL receiver e.g FM receiver designed for physical connection to Hearing Aid Classification follows the device Regulation follows device FM link adapter converts signal and therefore is an active medical device 4.2 WL FM receiver not in physical connection to Hearing Aid Classification follows the device Regulation follows device FM link adapter converts signal and therefore is an active medical device 5. Battery (primary cell) No No Multipurpose product and though not an accessory according to MDD 6. Battery (rechargeable) No No Multipurpose product and though not an accessory according to MDD 7. Battery tester No No Multipurpose product and though not an accessory according to MDD
8. Bone Conductor (no implant) 2 874.3300 A hearing aid is wearable device that is intended to compensate for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) LXB not exempted from 510k A bone conductor directly affects the output of hearing aids.. 9. (BTE) hearing aids Class 1 874.3300 A hearing aid is wearable device that is intended to compensate for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), ESD Exempted from 510k (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. conduction
and tinnitus masker (874.3400) 9.1 Wireless (BTE) hearing aids Class 2 874.3305 wearable device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. OSM Exempted from 510k (special controls). The special controls for this device are (see 874.3305) 10. Body-worn hearing aids (BW) Class 1 874.3300 A hearing aid is wearable device that is intended to compensate for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) ESD Exempted from 510k (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. 11. Charger (for rechargeable batteries) No No Multipurpose product and though not an accessory 12 Charger (designed for No No Manufacturers can decide to classify as MD or not. If
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
of the hearing aid. It is therefore defined as an accessory, but is - since it may be used for other purposes - not a medical device. 15. CROS unit (including microphone and a telecoil) Classification follows the device Regulation follows device An option, and hence not an integral part of the hearing aid. Though an accessory 16. hearing aid No No Not functional, and therefore not a medical device 17.1 Earmould Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety. 17.2 Ear mold Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety. 18. Ear dome (standard e.g dome) Classification follows the device Regulation follows device An earmould is a detachable part that can affect safety 19. Earphone (e,g used with bodyworn) Classification follows the device Regulation follows device An earphone directly affects the output of body worn hearing aids. 20. Eyeglass hearing aid (EG) Class I 874.300 A hearing aid is wearable device that is intended to compensate ESD Exempted from 510k (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction
for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400) hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. 21. Eyeglass adaptor Classification follows the device Regulation follows device An option, and hence an integral part of the hearing aid 22. Ear Hook Classification follows the device Regulation follows device A detachable part, and an integral part of the hearing aid 23. Impression material N/A Not classified Defined “Kit, earmold , impression” in FDA data base LDG 510(k) A substance that, although for temporary use, may have health and safety implications. (Unclear if this relates to implanted middle ear mold or to ear molds used for air hearing aids. ) 24. In-the-ear (ITE) / custom made hearing aid Class 1 874.300 A hearing aid is wearable device that is intended to compensate for impaired hearing. ESD (LRB= Exempted from 510k Faceplates have their own product code = LRB and are considered as a component. (1) Class I (general controls) for the air-conduction hearing
This generic type of device includes the hearing aid and the hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400 Face plate) aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9. 24.1 Wireless (ITE) / custom made hearing aid Class 2 874.3305 wearable device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. OSM (LRB= Face plate) Exempted from 510k (special controls). The special controls for this device are (see 874.3305) Faceplates have their own product code = LRB and are considered as a component. 25. ITE assembly In-the-ear (ITE) / custom made hearing aid (Non WL) Class 1 874.300 A hearing aid is wearable device that is intended to compensate for impaired hearing. This generic type of device includes the hearing aid and the hearing aid, but excludes the group ESD (LRB= Face plate) Exempted from 510k Faceplates have their own product code = LRB and are considered as a component. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.
29.1 Programming interface (e.g Hi Pro, NOAH link) Classification follows the device Regulation follows device A programming device intended to be temporarily (transient) connected by wire to a Hearing aid transmitting predefined program into the hearing aid. For an In –The hearing aid the programming cable extends into the ear canal making it invasive. 29.2 Programming Interface (Wireless) Classification follows the device Regulation follows device A wireless programming device specifically intended to be used with Hearing Aid transmitting a program wirelessly by a signal (energy), between a PC or similar device that alters/manages the program to a hearing aid without any significant change. 30. Remote control (integral) Classification follows the device Regulation follows device An integral remote control is an essential part of the hearing aid, the aid will not function without. 31. Remote control (optional) Classification follows the device Regulation follows device An optional remote control is an accessory that is sold separately, but is intended to control the hearing aid parameters in use. 32.1 Remote microphone Classification follows the device Regulation follows device A dedicated microphone specifically designed and
intended to be used with hearing aids. 32.2 Remote microphone No No Multipurpose product occasionally used in the medical environment and not specifically designed to be used with hearing aids 33. Repair tool No No No Repair tools are Multipurpose product and though not an accessory according to MDD. 34. Software (fitting) Classification follows the device Regulation follows device software for hearing aid fitting 35. Software (integrated) Classification follows the device Regulation follows device An integral part of the hearing aid 36. Spare part No No Spare parts for service/repair are not medical devices 37. Tamperproof battery cover Classification follows the device Regulation follows device An option, and hence an integral part of the hearing aid 38. Volume control cover Classification follows the device Regulation follows device An option, and hence an integral part of the hearing aid 39. Wax filter No No An option, and an integral part of the hearing aid. To be seen as a spare part. 40. Receiver in the Ear unit Classification follows the device Regulation follows device A detachable part that is an integral part of the hearing aid
41 Tinnitus masker Class 2 874.3400 A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in KLW (special controls). The special controls for this device are (see 874.3400) 510 k required 41. APP (That does not drive or influence the device) Classification follows the device Regulation follows device Mobile Medical Application (Mobile Medical App) mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4; and either is intended: to be used as an accessory to a regulated medical device; An APP that might have diagnostic purpose and doesn’t include a RC or has a function that directly influences the device. 42. APP (that drives or influences the device) Classification follows the device Regulation follows device Mobile Medical Application (Mobile Medical App) mobile app that meets the definition of device in section 201(h) An APP including a Remote Control that changes a program setting or directly influences the SW parameters of the device