Implantable hearing devices include cochlear implants and non-cochlear implants (or implantable hearing aids).
Cochlear implants are considered a relevant sector of public health as they are used in a large number of pediatric patients and represent a very advanced technology with a significant impact on the quality of life. The number of surgeries, which has more than doubled over the last 20 years, has a weighty economic impact on the national health system estimated to be more than 20 million euros per year. In addition to this, a considerable regional disparity in access to care and difficulty of gathering evidence on the safety of implanted devices can be observed.
Non-cochlear implants are a less numerous but more complex category of hearing aids with respect to cochlear implants. Actually, despite the limited number, classification is not a straightforward task due to the great variety of implants; moreover, their number is destined to increase and the cost of some of them almost equals that of cochlear implants.
Based on the above considerations, experts proposed to ISS to conceive and set up a national registry within the framework of the RIPI, in order to register interventions and collect data on effectiveness and safety of all implanted devices.
The first step towards the implementation of the Registry was the establishment of a Technical Committee with the following objectives:
- to map implants through the analysis of data considered by Hospital Discharge Records;
- to define the outcome of the registry starting from the analysis of the available literature and the experience gained from other similar registries, in particular the French one;
- to select the clinical variables to be collected in addition to the Hospital Discharge Record (minimum data set) useful to describe the technical aspects of surgery and therefore to collect data for the registry;
- to evaluate the registry information flow to be implemented on a national scale.