List of Aids
Product group 13
The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) in Germany publishes a systematiccaly structured List of Aids according to § 139 SGB V. At the same time, an attachment is created in the list of long-term care aids, due to the joint function as the National Assosiation of long-term care insurance funds. The list of aids catalogues assistive devices that are covered by the health and long-term care insurance funds and is divided into 38 product groups by therapeutic goals. The list of long-term care aids comprises four further product groups.
Besides the catalogue of assistive devices, the list of aids also contains mandadory minimum requirements for certain product gourps. We offer all necessary tests for all devices in product group 13 (hearing assistive devices) of the List of Aids. Across all subgroups, this includes a certification of the characeristics during type testing, and the creation of a report on the features, referred to as functional report. The specific test procedures and features to be verified depend on the appropriate product group and device type.
Product group 13 essentially contains the following subgroups:
- Devices with partially implanted sound sensors, PG13.20.06
- Stethoset receivers and amplifiers, PG13.20.07
- Hearing aids for insured persons with profound hearing loss, PG13.20.10
- Hearing aids for insured persons with less than profund hearing loss, PG13.20.12 / PG13.20.22 / PG13.20.23
- Tinnitus devices, PG13.20.14
- Non-implantable bone conduction hearing aids with contact pressure, PG13.20.15
- Non-implantable bone conduction hearing aids without contact pressure, PG13.20.16
Contact us if case of questions regarding the classification, minimum requirements or general questions on the list of aids.
Request for type testing
To request a testing for approval in the List of Aids, please send uns the following documents:
- Request for type testing1,2
- Request for creation of a functional report1,2
- Functional report request questionnaire1
- Data catalogue1
- Sample device
- Measurement data of the sample device1
- Datasheet of the device type under test, in German
- Functional diagram of the device type under test
- Software and programming cable for the device type under test
- Authorization of the legal manufacturer, if the legal manufacturer and applicant are not identical
1Please use the DHI templates for these documents. The templares are available on the secured download page.
2Documents must be sent either in paper with original signature, or digitally with an electronic signature that is legally equivalent to an original signature.
Qualified electronic signature
After testing was completed successfully, you receive test certificates for submission to the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). A digigtal submission of the certificates is possible for several product groups. We provide you all documents in electronic form with a qualified electronic signature, which is legally equivalent to an original signature. Find more information on the digital submission in our download area. Also after completed testing we are happy to support you on any remaining questions.
Equality of design
Private label devices
In the data catalogue, applicants have the possibility to register special versions of a device with equal design. These are devices, where the technical characteristics and acoustic features are identical to the type that is tested. Special versions are usually so-called "private lable" products. Registration of special versions is not specially checked, and is under the responsibility of the legal manufacturer.
If you want to supplement a special version after a type testing was completed, please use the appropriate request form from the download area. Please note that this form has to be originally signed and sent via mail.