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.

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.

[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.

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.

[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.

[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.

Novel biodegradable Round Window Disks for inner ear delivery of dexamethasone.

Drug delivery to the inner ear is an important and very challenging field. The cochlea is protected by several barriers that need to be overcome in the drug delivery process. Local drug delivery can avoid undesirable side effects arising from systemic drug delivery. We developed a biodegradable dexamethasone-loaded Round Window (RW) Disk based on poly(D,L-lactic-co-glycolic acid) (PLGA) for local drug therapy to the inner ear by RW membrane administration by a film-casting method. The optimal drying time was characterized by thermogravimetric analysis and differential scanning calorimetry. In addition, the mass and polymer degradation over time of drug release was measured in vitro showing a total mass loss of 70% after 3 weeks. Dexamethasone release was determined by a RW model setup using a polyethylene terephthalate membrane. We achieved a controlled release over 52 days. Ex vivo implantation of a RW Disk onto a guinea pig RW membrane indicated well-fitting properties of the drug delivery device leading to a close surface contact with the membrane and the successful proof of concept. The developed RW Disks could be new and promising drug delivery device to achieve effective local drug delivery to the inner ear for an extended time.