intended to be used with hearing aids. Multipurpose product occasionally used in the Remote 32.2 No No medical environment and not microphone specifically designed to be used with hearing aids Repair tools are Multipurpose 33. Repair tool No No No product and though not an accessory according to MDD. Classification Regulation software for hearing Software 34. follows the follows aid fitting (fitting) device device Classification Regulation An integral part of the hearing Software 35. follows the follows aid (integrated) device device Spare parts for service/repair 36. Spare part No No are not medical devices Classification Regulation An option, and hence an Tamperproof 37. follows the follows integral part of the hearing aid battery cover device device Classification Regulation An option, and hence an Volume 38. follows the follows integral part of the hearing aid control cover device device An option, and an integral 39. Wax filter No No part of the hearing aid. To be seen as a spare part. 40. Receiver in the A detachable part that is an Classification Regulation Ear unit integral part of the hearing aid follows the follows device device
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
Classification-Document-v14.4.docx