connection to MEDDEV Hearing Aid 2.1/1 Apr 94 1.2 MEDDEV Multipurpose product and though not Battery 5. No 2.1/1 Apr 94 No an accessory according to MDD No No (primary cell) 1.1g MEDDEV Multipurpose product and though not Battery 6. No 2.1/1 Apr 94 No an accessory according to MDD No No (rechargeable) 1.1g MEDDEV Multipurpose product and though not 7. Battery tester No 2.1/1 Apr 94 No an accessory according to MDD No No 1.1g Active A bone conductor directly affects the medical output of hearing aids, and is device therefore classified as IIa. They are (non-invasive also sold separate from the hearing active aid, and must therefore be CE marked. therapeutic device that Bone 8. IIa Rule 9 administers Yes Conductor energy and acts by converting electrical output to vibration) Active medical 9. (BTE) IIa device Yes Rule 9 hearing aids (non-invasive active
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
Classification-Document-v14.4.docx