Tests for listing devices in group 13 of the Lists of Aids (Hilfsmittelverzeichnis) published by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband)
We offer homologation and test measurements for all devices of group 13 of the Lists of Aids (Hilfsmittelverzeichnis) published by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany. Among others, this includes the devices of the following sub-groups:
- Devices with partly implanted parts, e.g. bone anchored hearing aids PG13.20.06
- Hearing aids for hearing impaired insured with profound hearing loss PG13.20.10
- Hearing aids for hearing impaired insured, excluding insured with profound hearing loss PG13.20.12/20
- Tinnitus devices PG13.20.14
- Bone conduction hearing aids PG13.20.15
IEC 60118-0 is the basic standard for the testing and characterization of hearing aids. For international use, the corresponding test reports are in English and include beside the signets of the DAkkS und ZLG also the ILAC signet.
Since the homologation of hearing aids already includes a significant part of IEC 60118-0, these measurements can not only be ordered as separate test but also in combination with the homologation of hearing aids, which saves effort, time and money. The application sheet for tests according to IEC 60118-0 can be downloaded here.
Hearing aids in combination with hearing protectors as medical devices and personal protective equipment (PPE)
In November 2020, the guidance document DGUV Grundsatz 312-002 was published by the German Social Accident Insurance (DGUV). According to this document, hearing aids can be tested to be used in combination with custom-made hearing protectors. For further information, we refer to the guidance document DGUV Grundsatz 312-002, and to our contribution on the Digital EUHA Congress 2020 “Custom-made hearing protectors with hearing aids as medical devices and personal protective equipment (PPE)”.
On request, we also offer other or special tests not listed above.