N1.1 Pocket hearing aid

N1.2 Suspended hearing aid

N1.2.1 Moderate somnolence

N1.2.2 Severe and very severe hearing loss

N1.3 Soundwater hearing aid

N1.3.1 Moderate somnolence

N1.3.2 Severe and very severe hearing loss

The Categorisation Commission for Medical Devices hereby urges the manufacturers of medical devices in the group N na supplementing the specifications for hearing aids meeting the criteria for inclusion in the new sub-group Combined hearing aids for individual products already included in the list of categorised medical devices or whose applications for inclusion of a medical device in those subgroups have been submitted to the electronic categorisation portal.
The Categorisation Commission for Medical Devices hereby urges the manufacturers of medical devices in the group N na supplementing the specifications of hearing aids suitable for children under 10 years of age and under 18 years of age for individual products already included in the list of categorised medical devices or whose applications for inclusion of a medical device in those subgroups have been submitted to the electronic categorisation portal.
Required information on medical devices in the group N to be sent to zdravom@health.gov.sk in period until 31.8.2015