Structure and establishment of the German Cochlear Implant Registry (DCIR) <span class="so-article-trans-title" dir="auto"> Translated title: Struktur und Einrichtung des Deutschen Cochlea-Implantat-Registers (DCIR) </span>

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Abstract

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

Supplementary Information

The online version of this article (10.1007/s00106-023-01310-0) contains supplemental material: Data blocks CI registry.

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Most cited references 6

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Cochlear Implantation: Diagnosis, Indications, and Auditory Rehabilitation Results

Stefan Dazert*, Jan Peter Thomas*, Andreas G. Loth … (2020)

Hearing impairment that is too severe to be adequately treated with conventional hearing aids can lead, in children, to severe developmental disturbances of hearing and language, and, in adults, to communicative and social deprivation. Recent advances in medical device technology and in microsurgical techniques have led to an expansion of the indications for cochlear implantation (CI) for adults with progressive hearing loss in older age, and to a restructuring of the process of care for these patients in Germany. This review is based on pertinent publications retrieved by a selective search in PubMed, as well as on the CI guidelines and CI “white book” of the German Society of Otolaryngology and Head and Neck Surgery. Early and accurate diagnosis is crucial for the successful auditory rehabilitation of high-grade hearing impairment. In children, a key role is played by newborn auditory screening, which is mandatory in Germany and enables the provision of a CI in the first year of life when necessary. 86% of the children receiving a CI achieve linguistic comprehension of fluently spoken sentences. For adults, positive prognostic factors for hearing after the provision of a CI include a highly motivated patient, “postlingual” onset of the hearing impairment (i.e., after the acquisition of language), and a brief duration of deafness. Auditory rehabilitation is associated with significant improvement, not just of hearing and of the comprehension of spoken language, but also of quality of life, particularly in elderly patients. For patients of any age with bilateral hearing loss, CIs should be provided on both sides, if possible. The more common complications of the procedure, with a probability of 2–4% each, are technical implant defects, dizziness, and wound-healing disturbances. Cochlear implantation, performed in specialized centers, is a safe and reliable technique and regularly enables the successful rehabilitation of hearing in both children and adults.

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The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report.

F M Lampert, M. Schwarz, S. Grabin … (2012)

Following the clinical observation of high rate of ruptures of breast implants of the French manufacturer Poly Implant Prothèse (PIP), the French Health Products Safety Agency (Afssaps) removed these products from the market in March 2010. Physical and toxicological tests confirmed the use of silicone of improper quality both for the shell and the gel filling. Until now (12/2011), no acute toxicity or mutagenicity could be observed, but 20 cases of malignancies occured in carriers of PIP-prostheses. By means of a clinical example, we summarize the official recommendations of the Afssaps and its German equivalent, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) for diagnosis and treatment in women with PIP breast implants. Furthermore, we intend to raise awareness for the fact that the German GfE Medizintechnik and the Dutch manufacturer Rofil distributed the identical product with a different label. Supplementary, the medical and medico-legal aspects of the "PIP scandal" are discussed.

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Quality control in cochlear implant therapy: clinical practice guidelines and registries in European countries

A Loth, C Vazzana, M Leinung … (2022)

Purpose The treatment with a cochlear implant (CI) is the gold standard in therapy of patients with profound hearing loss or deafness. Successful hearing rehabilitation with a CI is a complex, multi-stage process. In medicine, “Clinical Practice Guidelines” (CPG) are widely accepted for the standardization of such processes. These are supplemented by medical registries in which data regarding the treatment can be collected and evaluated. The aim of this paper is to identify currently existing CI-related CPGs and registries in Europe. Methods Between 01/2021 and 06/2021, 42 countries on the European continent, including the United Kingdom, Russia and Turkey, were screened using an internet search (search engine: Google) and a key word search in the Pubmed database. Search terms were the respective country name combined with the following terms: “Cochlear Implant”, “CI”, “Cochlear implant clinical practice guideline”, “CI Guideline”, “Cochlear Implant Registry”, “CI Registry”, “Ear nose throat society”. The internet search was conducted in English as well as in the corresponding national language. The objective was to identify a CI-related CPG or registry. Results A CPG was found in 16 of 42 (38%) countries. In terms of population, this accounts for 645 million out of 838 million people (77%). A registry existed in 4 of the 42 (10%) countries assessed. This corresponds to 102 million out of 838 million (12%) people. In total, 4 out of 42 countries (10%) had both a CPG and a registry. Conclusion Our work shows numerous efforts in Europe to standardize CI care at the national level. While most people in Europe already live in countries with a CPG, this is not the case for CI registries. European-wide consensus on CPGs or registries does not yet exist. The present study thus provides a first assessment of the distribution of CI-related CPGs and registries.

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Author and article information

Contributors

T. Stöver: timo.stoever@kgu.de

Journal

Journal ID (nlm-ta): HNO

Journal ID (iso-abbrev): HNO

Title: Hno

Publisher: Springer Medizin (Heidelberg )

ISSN (Print): 0017-6192

ISSN (Electronic): 1433-0458

Publication date (Electronic): 18 July 2023

Publication date PMC-release: 18 July 2023

Publication date (Print): 2023

Volume: 71

Issue: Suppl 1

Pages: 82-92

Affiliations

[1 ]GRID grid.411088.4, ISNI 0000 0004 0578 8220, Department of Otorhinolaryngology, , University Hospital Frankfurt, ; Theodor-Stern-Kai 7, 60590 Frankfurt, Germany

[2 ]Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Halle, Halle (Saale), Germany

[3 ]GRID grid.275559.9, ISNI 0000 0000 8517 6224, Department of Otorhinolaryngology, , Jena University Hospital, ; Jena, Germany

[4 ]Hospital for Otorhinolaryngology, Klinikum Nordstadt, Hanover, Germany

[5 ]GRID grid.4488.0, ISNI 0000 0001 2111 7257, Department of Otorhinolaryngology, , Dresden University Hospital, ; Dresden, Germany

[6 ]Department of Otorhinolaryngology, Ludwigshafen Hospital, Ludwigshafen, Germany

[7 ]GRID grid.411339.d, ISNI 0000 0000 8517 9062, Department of Otorhinolaryngology, , Leipzig University Hospital, ; Leipzig, Germany

[8 ]Law office WBK, lawyer specialist medical law, Cologne, Germany

[9 ]GRID grid.411091.c, Department of Otorhinolaryngology, , University Hospital (St. Elisabeth Hospital), ; Bochum, Germany

Article

Publisher ID: 1310

DOI: 10.1007/s00106-023-01310-0

PMC ID: 10409674

PubMed ID: 37462684

SO-VID: 6e8ad9c1-8a7e-4a5e-b4d8-1d6403bcc2a9

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date accepted : 2 June 2023

Funding

Funded by: Johann Wolfgang Goethe-Universität, Frankfurt am Main (1022)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

Custom metadata

Keywords: rehabilitation,implantable neurostimulators,prostheses and implants,certification,quality control

Data availability:

Keywords: rehabilitation, implantable neurostimulators, prostheses and implants, certification, quality control

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