The German cochlear implant registry: one year experience and first results on demographic data.

PURPOSE: Clinical registries have great potential for quality control of medical procedures regarding the indications, therapeutic processes and results, including their possible complications. This is particularly true when providing patients with severe hearing loss or deafness with a cochlear implant (CI). This treatment represents a lifelong care process that requires continuous quality control over time. On the initiative of the Executive Committee of the German Society of Otorhinolaryngology (Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V., DGHNO-KHC), a national German CI registry (Deutsches Cochlear Implant Register, DCIR) was established in January 2022. This article focuses on the first demographic and baseline data of the DCIR. METHODS: The DCIR covers the complete therapeutic process from indication, surgery, fitting and lifelong aftercare in CI therapy. By the end of 2022, 75 hospitals in Germany had agreed to contribute to the DCIR. RESULTS: During the year 2022, 63 hospitals actively contributed data to the DCIR. Pseudonymized data from 2,292 CI implantations (2,176 primary implantations, 99 explantations with immediate re-implantations and 17 re-implantations following an earlier explantation) in 2,108 patients were documented. Cochlear implantation was accomplished in 1,807 adults (≥ 18 years) and 301 children (< 18 years). Fourty patients (1,9%) were children < 1 year of age and 55 (2,6%) were patients > 85 years. From the total of 2,292 implantations, 226 (9.9%) were performed as simultaneous bilateral implantations (CI implantation in both ears of 113 patients on the same day of surgery) and 412 implantations (19.1% of 2,162 implantations with data provided on the contralateral ear's hearing status) were in patients with single sided deafness (normal hearing in the contralateral ear). In addition, the reported complications in 2022 were also evaluated. Seven reports (0.4%) of mild to moderate severe facial nerve dysfunctions were documented. No reports of severe or total facial nerve dysfunction (House-Brackmann grade V/VI), meningitis or death related to CI therapy were documented. CONCLUSION: Although still in the start-up phase, these initial DCIR data already provide an interesting first insight into the demographic structure and baseline data of CI therapy in Germany. The successful implementation of the DCIR represents an important step towards continuous quality control of CI care.

Structure and establishment of the German Cochlear Implant Registry (DCIR).

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.

Towards the optimization of drug delivery to the cochlear apex: Influence of polymer and drug selection in biodegradable intracochlear implants.

There is growing need for new drug delivery systems for intracochlear application of drugs to effectively treat inner ear disorders. In this study, we describe the development and characterization of biodegradable, triamcinolone-loaded implants based on poly(lactic-co-glycolic acid) (PLGA) and polyethylene glycol-poly(lactic-co-glycolic acid) (PEG-PLGA) respectively, prepared by hot-melt extrusion. PEG 1500 was used as a plasticizer to improve flexibility and accelerate drug release. The sterilization process was performed by electron beam irradiation, resulting in minimal but acceptable polymer degradation for PEG-PLGA implants. The implants have been characterized by texture analysis, differential scanning calorimetry and X-ray powder diffraction. Compared to PLGA implants, PEG-PLGA implants offer similar flexibility but with improved mechanical stability, which will ease the handling and intracochlear application. A controlled release over three months was observed for dexamethasone and triamcinolone extrudates (drug load of 10%) with similar release profiles for both drugs. PEG-PLGA implants showed an initial slow release rate over several days regardless of the amount of PEG added. Mathematical simulations of the pharmacokinetics of the inner ear based on the in vitro release kinetics indicate a complete distribution of triamcinolone in the whole human scala tympani, which underlines the high potential of the developed formulation.

Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification program and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification program and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification program for quality control in CI care was successfully implemented in Germany.

[Structure and establishment of the German Cochlear Implant Registry]. / Struktur und Einrichtung des Deutschen Cochlea-Implantat-Registers (DCIR).

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.

[Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany. German version]. / Konzeption und Implementierung eines Zertifizierungssystems zur Qualitätssicherung der Cochlea-Implantat-Versorgung in Deutschland.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification system and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification system and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification system for quality control in CI care was successfully implemented in Germany.

[Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system. German version]. / Planungstools und Indikationen zur "virtuellen Chirurgie" beim Knochenleitungssystem Bonebridge.

BACKGROUND: Implantation of the Bonebridge (MED-EL, Innsbruck, Austria), an active semi-implantable transcutaneous bone conduction hearing system, involves the risk of impression or a lesion in intracranial structures, such as the dura or sigmoid sinus. Therefore, determining the optimal implant position requires careful preoperative radiological planning. OBJECTIVE: The aim of this study was to provide an overview of the possibilities for preoperative radiological planning for the Bonebridge implantation and to evaluate their indications and feasibility. MATERIALS AND METHODS: A systematic literature search was conducted in the PubMed/MEDLINE database for all studies with preoperative planning or implant placement as the primary endpoint or that secondarily mention preoperative planning. RESULTS: Of 558 studies, 49 fulfilled the inclusion criteria. In 18 studies, preoperative planning and floating mass transducer (FMT) placement were the primary endpoints, whereas in 31 studies, preoperative planning was described secondarily. CONCLUSION: There are both freely available and commercial tools involving different time commitments for preoperative three-dimensional (3D) planning and intraoperative transfer. Preoperative 3D planning can increase the safety of Bonebridge implantation.

[Teaching during the COVID-19 pandemic: how do medical students evaluate interactive video-based distance bedside teaching in otorhinolaryngology?] / Ausbildung in COVID-19-Pandemie-Zeiten: Wie bewerten Medizinstudierende einen interaktiven, videobasierten Distanzunterricht am Patienten im Fach Hals-Nasen-Ohren-Heilkunde?

BACKGROUND: The first wave of the SARS-CoV­2 pandemic required substantial changes in the teaching of medical students, with strict avoidance of direct contact between students and patients. Therefore, the teaching format "bedside teaching" was implemented and conducted as an interactive video-based distance bedside teaching. OBJECTIVE: The objective of this study was to analyze a students' evaluation of this teaching concept in otorhinolaryngology. MATERIALS AND METHODS: From an ENT examination room, the situation was transmitted live to the students in a lecture hall, who could interact with the patients through a video connection. Macro-, micro-, and endoscopic images were transmitted into the lecture hall in real time. Evaluation was performed by means of an online questionnaire with 13 questions (Likert scale) as well as by free-text feedback. RESULTS: The response rate was 16.8% (42 of 250 students). Overall, 85.7% had a positive impression, and it was generally considered that the concept was well implemented in light of the special situation. However, students would rather not renounce direct patient contact, even if a certain compensation by video transmission was reported. Overall, this teaching concept was considered as educative, and students could imagine using such a teaching concept more often in the future. CONCLUSION: This teaching model cannot replace classical bedside teaching, but represents a good alternative-particularly in otorhinolaryngology-if classical bedside teaching is not possible due to the pandemic situation. Aspects of the interactive video-based distance bedside teaching could be implemented into classical teaching concepts in the future.

Bone conducted vibration is an effective stimulus for otolith testing in cochlear implant patients.

BACKGROUND: Treatment with a cochlear implant (CI) poses the risk of inducing a behaviorally unmeasurable air-bone gap leading to false negative absence of cervical and ocular vestibular evoked myogenic potentials (cVEMPs, oVEMPs) to air conducted sound (ACS). OBJECTIVE: To investigate VEMP response rates to ACS and bone conducted vibration (BCV) in CI patients and the applicability of the B81 transducer for BCV stimulation. METHODS: Prospective experimental study including unilateral CI patients, measuring cVEMPs and oVEMPs to ACS and to BCV, comparing response rates, signed asymmetry ratios, latencies, and amplitudes. RESULTS: Data of 13 CI patients (mean age 44±12 years) were analyzed. For the CI side, oVEMP and cVEMP response rates were significantly higher for BCV (77%cVEMP, 62%oVEMP) compared to ACS (23%cVEMP, 8%oVEMP). For the contralateral side, no difference between response rates to ACS (85%cVEMP, 69%oVEMP) and BCV (85%cVEMP, 77%oVEMP) was observed. Substantially higher asymmetries were observed for ACS (-88±23%for cVEMPs, -96±11%for oVEMPs) compared to BCV (-12±45%for cVEMPs, 4±74%for oVEMPs). CONCLUSIONS: BCV is an effective stimulus for VEMP testing in CI patients. The B81 is a feasible stimulator.

[Dupilumab has an additional benefit in treatment of chronic rhinosinusitis with nasal polyps]. / Dupilumab besitzt einen Zusatznutzen für die Behandlung der chronischen Rhinosinusitis mit Nasenpolypen.

BACKGROUND: For patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) which cannot be controlled by continuous therapy with intranasal corticosteroids (INCS) and systemic corticosteroids and/or surgical treatment, there were no approved curative options for a long time. For CRSwNP treatment with T2-addressing biologics is possible. On October 24, 2019, the European Commission granted extended approval for dupilumab as the first biological agent for treatment of insufficiently controlled severe CRSwNP. The Federal Joint Committee (G­BA) evaluates the benefits of reimbursable drugs with new active ingredients. This includes assessment of the additional benefit and its therapeutic relevance. METHODS: A meta-analysis was performed using individual patient data based on two phase III studies. Both studies examined the safety and efficacy of dupilumab as an add-on therapy to INCS for treatment of CRSwNP in adults inadequately controlled with systemic corticosteroids and/or surgery compared to INCS alone. RESULTS: Based on the present data, the G­BA decided that there is an indication of a considerable additional benefit of dupilumab compared to mometasone furoate. CONCLUSION: For patients with severe CRSwNP inadequately controlled with INCS and systemic corticosteroids and/or surgery, there is an indication of a considerable additional benefit for the administration of dupilumab as an add-on therapy to INCS compared to mometasone furoate alone.

Planning tools and indications for "virtual surgery" for the Bonebridge bone conduction system.

BACKGROUND: Implantation of the Bonebridge (MED-EL, Innsbruck, Austria), an active semi-implantable transcutaneous bone conduction hearing system, involves the risk of impression or a lesion in intracranial structures, such as the dura or sigmoid sinus. Therefore, determining the optimal implant position requires careful preoperative radiological planning. OBJECTIVE: The aim of this study was to provide an overview of the possibilities for preoperative radiological planning for the Bonebridge implantation and to evaluate their indications and feasibility. MATERIALS AND METHODS: A systematic literature search was conducted in the PubMed/MEDLINE database for all studies with preoperative planning or implant placement as the primary endpoint or that secondarily mention preoperative planning. RESULTS: Of 558 studies, 49 fulfilled the inclusion criteria. In 18 studies, preoperative planning and floating mass transducer (FMT) placement were the primary endpoints, whereas in 31 studies, preoperative planning was described secondarily. CONCLUSION: There are both freely available and commercial tools involving different time commitments for preoperative three-dimensional (3D) planning and intraoperative transfer. Preoperative 3D planning can increase the safety of Bonebridge implantation.

[Effects of the SARS-CoV­2 pandemic on the otolaryngology university hospitals in the field of research, student teaching and specialist training]. / Auswirkungen der SARS-CoV­2-Pandemie auf die universitäre Hals-Nasen-Ohren-Heilkunde im Bereich der Forschung, Lehre und Weiterbildung.

BACKGROUND: From spring 2020, SARS-CoV­2 began to spread worldwide, with what is now known as the first wave of the pandemic, starting in March 2020. This resulted in restructuring and shift of resources at many hospitals. The aim of our work was to detect the effects of the pandemic on the german Oto-Rhino-Laryngology (ORL) university hospitals in terms of research, student teaching and further specialist training. MATERIAL AND METHODS: The chairmen of the 39 ORL university hospitals in Germany were asked about the effects of the pandemic on research, student teaching and ORL specialist training (residency) in the period from March to April 2020 using a structured online survey. RESULTS: All 39 chairmen took part in the survey. Of these, 74.4% (29/39) stated that their research activities had deteriorated as a result of the pandemic. In 61.5% (24/39) pandemic-related research issues were addressed. All hospitals reported a restriction for in-house teaching and 97.5% (38/39) introduced new digital teaching methods. During the observation period, 74.4% of the chairmen did not see ORL specialist training (residency)at risk. CONCLUSION: Our results provide an insight into the heterogeneous effects of the pandemic. The fast processing of pandemic-related research topics and the introduction of innovative digital concepts for student teaching impressively demonstrates the great innovative potential and the ability of the ORL university hospitals to react quickly in order to maintain their tasks in research, student teaching and ORL specialist training in the best possible way even during the pandemic.

[Functional results after soft palate reconstruction in oropharyngeal cancer patients]. / Funktionelle Ergebnisse nach Rekonstruktion des weichen Gaumens bei Patienten mit Oropharynxkarzinom.

BACKGROUND: Surgery of the soft palate in patients with oropharyngeal cancer can result in functional deficiencies of swallowing and speech. Reconstruction of the resected structures can contribute to regaining sufficient functionality after therapy. OBJECTIVE: The current study used frequency analysis to evaluate the change in speech characteristics after resection and reconstruction of the soft palate during post-therapeutic follow-up. MATERIALS AND METHODS: In 18 patients with oropharyngeal carcinoma and involvement of the soft palate, resection and reconstruction by free radial forearm graft (FRFG) and adjuvant chemoradiotherapy was conducted. The spoken German numbers "eins", "zwei", "drei", "vier", "fünf" were recorded during follow-up and objectively assessed by frequency analysis. Additionally, food intake status and the necessity of a tracheostomy were evaluated. RESULTS: The maximum peak frequencies of the numbers analysed increased from 150-300 Hz before up to 1000 Hz after therapy. Two years post therapy, the peak frequencies again declined to levels comparable to those before tumour therapy. One year after therapy, complete oral nutrition was possible in two thirds of patients and the tracheostomy was closed in 80%. CONCLUSION: Reconstruction of the soft palate by FRFG during the course of oropharyngeal cancer treatment allows function to be regained with respect to speech and swallowing. In the majority of patients, it is possible to reach a level of function comparable to the state before tumour treatment.