When choosing between different treatment options, implants often appear too costly. However, this perspective does not take future costs into account. This article evaluates lifetime costs for different surgical interventions to treat hearing loss. The analysis focused on three groups from the perspective of health insurers. Group 1 comprises patients who have only been implanted with a middle ear implant. Patients in Group 2 had already undergone middle ear surgery to improve hearing prior to the implantation of a middle ear implant. Group 3 consists of patients who were treated exclusively with hearing-improvement surgeries (no implant). The lifetime costs were calculated using the Monte Carlo simulation. The inputs were based on medical data from a maximum-care hospital and data from the German healthcare system. Based on an average observation period of 26.73 years, the lifetime costs amounted to 28,325€ for group 1, 32,187€ for group 2 and 28,381€ for group 3. While the mean values between groups 1 and 3 appear comparable, group 1 has a significantly lower standard deviation (G1 vs. G3: 6120€ vs. 10,327€). Choosing a treatment option can be a complex medical decision and impose a substantial economic burden for the statutory health insurance. Hence, treatment decisions should be patient-centred at first but also including a shared-decision making on economic feasibility, whether proposed treatment alternatives are likely to be successful and economically reasonable.

OBJECTIVES:The maximum output provided by a bone conduction (BC) device is one of the main factors that determines the success when treating patients with conductive or mixed hearing loss. Different approaches such as sound pressure measurements using a probe microphone in the external auditory canal or a surface microphone on the forehead have been previously introduced to determine the maximum output of active transcutaneous BC devices that are not directly accessible after implantation. Here, we introduce a method to determine the maximum output hearing level (MOHL) of a transcutaneous active BC device using patients' audiometric data. DESIGN:We determined the maximum output in terms of hearing level MOHL (dB HL) of the Bonebridge using the audiometric and direct BC threshold of the patient together with corresponding force levels at hearing threshold and the maximum force output of the device. Seventy-one patients implanted with the Bonebridge between 2011 and 2020 (average age 45 ± 19 years ranging from 5 to 84 years) were included in this study. The analyses of MOHLs were performed by (1) dividing patients into two groups with better or worse average audiometric BC threshold (0.5, 1, 2, 4 kHz), on the ipsilateral side or (2) by separating the MOHLs based on better or worse frequency-by-frequency specific audiometric BC thresholds on the ipsilateral (implanted) side. RESULTS:When using a frequency-by-frequency analysis obtained average ipsilateral MOHLs were in the range between 51 and 73 dB HL for frequencies from 0.5 to 6 kHz in the group with better audiometric BC threshold on the ipsilateral ears. The average contralateral MOHLs in the group with better contralateral hearing were in the range from 43 to 67 dB HL. The variability of the data was approximately 6 to 11 dB (SDs) across measured frequencies (0.5 to 6 kHz). The average MOHLs were 4 to 8 dB higher across frequencies in the group with better audiometric BC threshold on the ipsilateral ears than in the group with better audiometric BC threshold on the contralateral ears. The differences between groups were significant across measured frequencies ( t test; p < 0.05). CONCLUSIONS:Our proposed method demonstrates that the individual frequency-specific MOHL on the ipsilateral and contralateral side of individual patients with a transcutaneous BC device can be determined mainly using direct and audiometric BC threshold data of the patients from clinical routine. The average MOHL of the implant was found 4 to 8 dB higher on the ipsilateral (implanted) side than on the contralateral side.

Introduction The indication for treatment with a middle ear implant is primarily for patients with chronic hearing loss. The variance in middle ear pathology and the associated need to adapt the strategy for coupling the FMT to the ossicles is a constant challenge. The present study focuses on patients with postinflammatory meatal fibrosis (PIMF)

Objective: The frequency specific maximum output (MO) of active middle ear implants is the most crucial parameter for speech intelligibility. We determined individual MO from clinical routine data in round window (RW) coupling of the Vibrant Soundbridge (VSB). Design: Monocentric, retrospective analysis. Study Sample: 68 ears implanted with the VSB at the RW were analysed. Using bone conduction and direct threshold, MO was determined for combinations of implants (VORP502, VORP503) and processors (Samba, Amad & eacute;). Coupling modes were: (A) without coupler (N = 28), (B) spherical coupler (N = 19), (C) soft coupler (N = 10) or (D) custom-made "Hannover coupler" (N = 11). Results: The MO frequency dependence was similar for coupling types (A-D) with a maximum at 1.5 kHz. No differences between groups were observed, although the average MO of the soft coupler was 10 dB lower. The average MO (0.5, 1.0, 2.0, 4.0 kHz) was (A) 77.6 +/- 15.0 dB HL, (B) 81.0 +/- 11.1 dB HL, (C) 67.6 +/- 17.9 dB HL (C), and (D) 79.6 +/- 11.7 dB HL (D). Conclusion: The individual MO can be determined from patients' clinical data. It permits in-depth analyses of patient outcomes and definition of evidence-based indication and decision criteria.

This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. 49 (53.3

Introduction Since 2005 the Floating Mass Transducer (FMT) of the Vibrant Soundbridge (VSB) can be coupled directly or indirectly to the round window. Indirect coupling can be done via fascia, Tutopatch (TP), Round Window Coupler (RWC), Round Window Soft Coupler (RWS), or the CMD Hannover Coupler (HCV2). The aim of the study is (1) analyzing the safety of the RW vibroplasty and (2) the evaluation of the coupling efficiency.

Einleitung Die Indikation für die Versorgung mit einem Mittelohrimplantat ist vor allen Dingen bei Patienten mit chronischer Schwerhörigkeit gegeben. Die Varianz der Mittelohrpathologie und die damit verbundene notwendige Strategie Anpassung bei der Ankopplung des FMT an die Ossikel ist eine konstante Herausforderung. Die vorliegende Arbeit fokussiert auf Patienten mit Postinflammatorische Meataler Fibrose (PIMF)

ObjectiveThe dynamic range (DR) available to the patient is a central parameter to determine speech intelligibility in quiet. DesignIn this retrospective study, the DR for the Vibrant Soundbridge implanted in individual patients was calculated using in situ thresholds of the patients and technical data of the implant system. The average DR across frequencies (0.5, 1, 2, 4 kHz) was correlated with the patients' assigned word recognition score (WRS) in quiet. Study sampleA data set of 66 cases (4 bilateral and 2 revised cases) from 60 implanted patients between 14.3-81.8 years were analysed. ResultsThe relationship between DR and WRS was described by a sigmoidal growth function with R2=0.6371 and a maximum WRS (upper asymptote) of 93.5%. Word recognition scores in quiet improved with increasing DR. A significant shift in performance was detected from DR bin 2 (10-20 dB, median WRS 55%) to bin 3 (20-30 dB, median WRS 80%) and from DR bin 4 (30-40 dB, median WRS 82.5%) to bin 5 (40-50 dB, median WRS 90%). ConclusionA minimum DR of 20 dB can yield sufficient speech intelligibility in quiet in implanted patients, however, an optimum DR is suggested to be 40 dB.

Einleitung Das Bonebridge System von MedEL ist ein aktives transkutanes Knochenleitungsimplantat für Patienten mit kombinierter Schwerhörigkeit oder Schallleitungsschwerhörigkeit, kann aber auch bei einseitiger Taubheit verwendet werden. Kinder ab 3 Jahren mit einer geringeren Knochendicke wurden bisher meist mit einem perkutanen knochenverankerten Hörsystem (BAHA), das nur eine geringe Insertionstiefe benötigt, oder mit einem aktiven Mittelohimplantat, welches nicht im Knochen verankert wird, versorgt, aber beide Ansätze haben Beschränkung und Risiken wie Dislokation und Infektion, die eine Revisionsoperation erzwingen können. Diese Komplikationen können mit aktiven transkutanen Knochenleitungsimplantaten vermieden werden. Die zweite Generation des Bonebridge zeigt eine reduzierte Höhe und des Implantats, die in einer verminderten Bohrtiefe resultiert, und kann somit auch bei jüngeren Kindern verwendet werden.

Introduction The active transcutaneous bone conduction implant system Sentio (Oticon Medical AB, Askim, Sweden) was developed to treat patients with conductive and mixed hearing loss, and single-sided deafness (SSD). The Sentio Ti implant is positioned under the skin behind the ear with the actuator placed in a bone bed and fixed on the mastoid with a fixation band and two screws. The external processor Sentio 1 is magnetically attached to the head. Currently, the Sentio is implanted as part of an international multicenter study (clinicaltrials.gov identifier NCT05166265). The aim of this report is to share preliminary audiological outcome and patient satisfaction for the Sentio system in the first SSD patients implanted at our clinic.

Introduction The MedEl Bonebridge system is an active transcutaneous bone conduction implant system for patients with conductive and mixed hearing loss but can also be used in cases of single-sided deafness. Children above three years of age with a lesser bone thickness were previously mainly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) due to its low depth of insertion into the bone or an active middle-ear implant which does not require anchoring in bone but both of these interventions have limitations and risks of complications like dislocation and infection potentially leading to revision surgery. These complications can be omitted with active transcutaneous bone conduction implant systems. The second generation of the Bonebridge (BCI 602) features a decreased thickness of the implant with reduced drilling depth and can thus be implanted in younger children.

PurposeDue to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance.MethodsIn this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software.ResultsAll patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance.ConclusionWith adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children.

Introduction The maximum output of a bone conduction device (BCD) is one of the main factors that determines the success when treating patients with conductive or mixed hearing loss. Here, we introduce a method to determine the maximum output hearing level (MOHL) of a transcutaneous active BCD using patients’ audiological data.

Einleitung An der Medizinischen Hochschule Hannover wird die Bonebridge bereits seit 2011 in Patienten mit konduktiven und kombinierten Schwerhörigkeiten oder als CROS-Versorgung bei einseitiger Taubheit implantiert. Eine Evaluierung der Langzeitperformance des BCI 601 in implantierten Patienten ist daher unerlässlich.

Einleitung Die Vibrant Soundbridge (VSB) gibt es schon seit 1996 und wurde regelmäßig mit neuen Sprachprozessoren aktualisiert.

Abstract Introduction The Hannover Coupler version 2 (HC2) was designed to (1) adapt the coupler geometry to the round window (RW) niche (2) to stabilize the floating mass transducer, and (3) to control static coupling forces to the RW. First audiological outcomes with a custom‐made HC2 are reported here. Material and Methods Ten patients were enrolled in our site‐initiated, prospective study. To assess audiological outcomes up to 6 months, preoperative and postoperative hearing thresholds, word recognition score (WRS) at 65 dB SPL and the speech recognition threshold in quiet and noise were performed. The effective gain (EG) and the coupling efficiency were calculated. Results One revision surgery had to be performed during the study period and a significant, but clinically not relevant bone conduction thresholds change was observed at 4 and 6 kHz at 6‐month follow‐up. At 6 months, the median WRS (n = 10) improved significantly from 0% to 80%. The median speech reception threshold in noise improved significantly from 11.6 to −2.4 dB SNR, and in quiet significantly from 79.6 to 44.4 dB SPL. The average EG of −1.3 dB indicated a closure of the air bone gap. The determined average coupling efficiency of 23.3 dB was within the acceptance range suggested by the manufacturer. Conclusion For patients with mixed hearing loss and multiple ear surgeries, the HC2 provided good and stable speech recognition results exceeding published results of RW coupling without a coupler or coupling with the RW soft coupler.

Einleitung Seit 2005 wird der Floating Mass Transducer (FMT) der Vibrant Soundbridge erfolgreich an die Rundfenstermembran gekoppelt. Eine Analyse der audiologischen Langzeitdaten wurde durchgeführt, (1) um den ersten verfügbaren Coupler (RW-Coupler) zu betrachten und (2) um die Sicherheit und Leistung dieser Ankopplung zu analysieren.

Introduction At the Hannover Medical School, the Bonebridge is used as a treatment for patients with conductive and mixed hearing loss or in cases of single-sided deafness (SSD) since 2011. An evaluation of the long-term performance of the BCI 601 in implanted patients is therefore indispensable.

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.