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95. Jahresversammlung der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie

Dr. med.

NUR Wissenschaftliches Programm/ ONLY Scientific Program

Dipl. Ing.

Prof. Dr.

PD Dr. med.

Benefit of the ADHEAR bone conduction device in patients with Otosclerosis with Stapes Fixation

Aktive Mittelohrimplantate / Knochenleitungshörsysteme

Leistung des ADHEAR-Knochenleitungshörgeräts bei Otosklerose-Patienten mit Stapesankylose

Introduction: Since five years the ADHEAR bone-conduction device, which is worn behind the ear with an adhesive patch, is available for temporary use. Patients with otosclerosis with stapes fixation with normal inner ear represent a homogeneous audiological group whom we tested with the ADHEAR. Material and Methods: Thirty patients with otoscleorsis where evaluated preoperatively with and without ADHEAR using pure tone audiometry and speech understanding tests (Freiburg numbers and monosyllables). The hearing perfomance was evaluated at four different presentation levels (35 dB, 50 dB, 65 dB and 80 dB) and compared with normal hearing subjects with simulated air-conduction hearing loss. Results: With ADHEAR, PTA4 improved by 7.2 dB in otoslerosis patients, in normal hearing subjects with simulated air-conduction by 14.6 dB. Numbers understanding with and without ADHEAR at 35, 50, 65, 80 dB was 3.3%, 20.9%, 72.0%, and 99.3% respectively 9.1%, 48.5%, 87.6%, and 96.3%. The improvement was statistically significant at 35 dB, 50 dB, and 65 dB. In normal hearing subjects with simulated air-conduction with ADHEAR numbers understanding was 69.2%, 97.9%, 100%, and 100%. Monosyllables understanding with and without ADHEAR at 35, 50, 65, 80 dB was 0.9%, 10.6%, 41.9%, and 84.8% respectively 1.8%, 21.9%, 60.6%, and 92.4%. The improvement was statistically significant at 50 dB, 65 dB, and 80 dB.In normal hearing subjects with simulated air-conduction, monosyllables understanding was 35.0%, 72.3%, 93.5%, and 98.8% (mean) with ADHEAR. Conclusions: ADHEAR improved in most of the test situations the speech understanding in patients with otoscleorsis. In difficult and easy situations there was a celling-effect present. Einleitung: Seit über fünf Jahren verfügen wir mit dem ADHEAR über ein nichtinvasives Knochenleitungshörgerät, das mittels eines Klebeadapters getragen werden kann und für eine passagere Verwendung geeignet ist. Patienten mit Otosklerose und Stapesankylose mit normalem Innenohr bilden eine audiologisch homogene Gruppe für die der Nutzen des ADHEAR evaluiert wurde. Material und Methoden: Dreißig Patienten wurden präoperativ mit und ohne ADHEAR ton- und sprachaudiometrisch mit Freiburger Zahlen- und Einsilbertest getestet. Die Hörleistung wurde bei vier Angebotsschallpegeln (35 dB, 50 dB, 65 dB und 80 dB) evaluiert und mit der Leistung normalhörender Probanden mit simulierter Schallleitungsstörung verglichen. Ergebnisse: Durch das ADHEAR verbesserte sich die PTA4 Freifeld-Hörschwelle der Patienten mit Otosklerose um 7,2 dB. Bei den normalhörenden Probanden mit simulierter Schallleitung um 14,6 dB. Das Zahlenverstehen ohne bzw. mit ADHEAR bei 35, 50, 65, 80 dB betrug 3,3%, 20,9%, 72,0% und 99,3% bzw. 9,1%, 48,5%, 87,6% und 96,3%. Die Verbessung ist signifikant bei 35 dB, 50 dB und 65 dB. Bei den normalhörenden Probanden mit simulierter Schallleitungsstörung war das Zahlenverstehen mit ADHEAR 69,2%, 97,9%, 100% und 100%. Das Einsilberverstehen ohne bzw. mit ADHEAR bei 35, 50, 65, 80 dB betrug 0,9%, 10,6%, 41,9% und 84,8% bzw. 1,8%, 21,9%, 60,6% und 92,4%. Die Verbesserung ist signifkant bei 50 dB, 65 dB und 80 dB. Bei den normalhörenden Probanden mit simulierter Schallleitungsstörung war das Einsilberverstehen mit ADHEAR 35,0%, 72,3%, 93,5% und 98,8%. Schlussfolgerung: ADHEAR verbesserte in den meisten Testsituationen bei den Otosklerose-Patienten die Sprachverständlichkeit signifikant. Bei sehr schwierigen und sehr leichten Bedingungen traten Sättigungseffkte auf.Die Autorinnen und Autoren geben an, dass kein Interessenskonflikt besteht.

Otologie / Neurootologie / Audiologie

Visual Abstract

Adverse events of the new generation of active bone conduction hearing implants (BCI602 and OSI200): a MAUDE database analysis

Unerwünschte Ereignisse der Implantationen mit der neuen Generation aktiver Knochenleitungsimplantate (BCI602 und OSI200): eine MAUDE-Datenbankanalyse

Background: A new generation of active transcutaneous bone conduction implants (BCI) are available since 2019 and literature comprising technical and medical complications is sparse. The aim of this investigation is to report on medical device reports submitted to FDA MAUDE database to identify adverse events (AEs) in patients implant with novel active BCIs. Methods: We conducted a search in the FDA MAUDE database using the device model numbers "BCI602 BONE CONDUCTION IMPLANT" (Medel, Innsbruck, Austria) and "COCHLEAR OSIA OSI200 IMPLANT" (Cochlear, Sydney, Australia). We collected data concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken, for the time period from December 1st, 2019 to July 24th, 2023. Results: In total, 569 AEs were documented, consisting of 89 device malfunctions and 480 patient injuries with 420 subsequent interventions. No device output (31.3%, n = 20) and loss of osseointegration (10.1%, n = 7) were most often AEs in BCI602 (total of 64 AEs). On the other hand, infection (33.9%, n = 171), extrusion of the device (21.2%, n = 107), and wound dehiscence (8.1%, n = 41) were the most frequently reported AEs for OSI200 (total of 505 AEs). Various AEs led to 237 (56.4%) explanations and 79 (18.8%) revision surgeries. Sixty-eight AEs (16.2%) required conservative treatment. Conclusion: The current study provides an overview on the most commonly reported complications in first three years of hearing rehabilitation with new active transcutaneous bone-conductions implants BCI602 and OSI200. Although providing a good overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution.Registrierungskosten (Faris F. Brkic) für den Deutschen HNO Kongress werden von der Firma Medel übernommen.

Safety and coupling efficiency of round window vibroplasty

Sicherheit und Ankopplungseffizienz der Rundfenster Vibroplastie

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. Material and Methods Inclusion criteria was a bone conduction threshold (BC) within the indication limit for RW vibroplasty +10 dB and within the measurement limit. Safety analysis included revision and explantation rates. The audiological results included BC and the coupling efficiency (CEF, in situ measurement - BC). The results were analyzed pre- and postoperatively after 2 month (2m), 2.7 (2y) and 5.4 (5y) years. The average is given as PTA4. Results The audiological analysis (n=56) showed a significant change in mean BC at 2y in groups HCV2 (n=12) and RWS (n=8) by 8.14 dB and 5.9 dB, respectively. Regarding safety analysis (n=76), 9 patients were explanted (n=3 deficit, n=2 implant defect, n=2 infections, n=2 cholesteatoma), 6 of whom received VSB reimplantation (n=5 RW vibroplasty) and the others acoustic implants (BAHA, Bonebridge, CODACS). Revisions (n=4) were caused by deficit (n=2) and medical reasons (n=1 related, n=2 non-related). A significant improvement in CEF was found at 5y for group RWC (n=14) at 4 and 6 kHz. A CEF of &gt; 35dB was found in 5 subjects (n=4 TP, n=1 HCV2) with a BC of 16.5 dB HL. No significant differences were found between the groups in terms of safety or CEF. Discussion The RW vibroplasty is a safe procedure. The coupling efficiency becomes more important the further the hearing loss progresses.The work of Ms. Knölke is sponsored by MED-EL. The authors received travel support by MED-EL to conferences. The authors disclose no conflicts of interest.

Current insights from the latest Bone-Conduction hearing Implant (BCI 602) – A systematic review and meta-analysis

Aktuelle Ergebnisse des neusten aktiven Knochenleitungs-Hörimplantats (BCI 602) - Eine Systematic Review und Meta-Analyse

Background: The BCI 602 is a new transcutaneous bone conduction implant with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of individuals implanted with the BCI 602 due to mixed or conductive hearing loss. Materials and Methods: Following the Preferred Reporting items for Systematic Reviews and Meta-Analyses guidelines, 107 studies were reviewed, and 6 (5.6%) were included in the meta-analysis. The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences between pre- and postoperative performances. Results: In total, 116 patients were evaluated. No intra-operative adverse events were reported, while postoperative complications were reported in 3% of patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; p &lt; 0.01), signal to noise ratio (n = 96; MD, -6.35 dB; p &lt; 0.01), and word recognition scores (n = 96; MD, 68.89%; p &lt; 0.01). Conclusion: The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other bone conduction implants and long-term functional outcomes.D.R. is receiving grants from MED-EL outside the submitted work. L.D.L. receives research funding from Decibel Therapeutics and Amgen and has worked as an independent consultant for Gerson Lehrman Group and Conclave Capital. No other disclosures were reported.

Prof. Dr. med.

Is the SoundArc preoperative wear trial useful as a predictive tool for assessing hearing impression prior to OSIA implantation?

Ist der präoperative Trageversuch mit SoundArc als prädiktives Mittel zur Einschätzung des Höreindrucks vor der OSIA- Implantation sinnvoll?

Introduction: The OSIA OSI 200 is a new implantable bone conduction hearing system that transmits sound vibrations to the inner ear using piezo technology. The implant (BI300) is connected to a bone conduction implant. The SoundArc is a bracket for attaching sound processors and offers a non-surgical wearing option. This study investigates how the SoundArc preoperative wear trial can predict hearing with the OSIA. Methods: In the study, 19 patients received a total of 20 OSIA implants, with an average age of 56 years. The indications ranged from combined hearing loss after tympanoplasty to moderate sensorineural hearing loss with problematic hearing aid fitting with recurrent otitis externa and/or psoriasis. The preoperative maximum monosyllabic recognition score using SoundArc was recorded at 65 and 80 dB in the speech audiogram and compared with the hearing result after the OSIA fitting. Patient satisfaction and the consistency of the hearing impression between OSIA and SoundArc were also investigated. Results: The Cochlear OSIA OSI200 implant operations went without complications. All patients were satisfied with the hearing impression of the OSIA. The hearing impression with OSIA was consistent with the expected hearing impression with SoundArc. Some patients performed better in the monosyllabic speech test with the OSIA, while others performed better with the SoundArc. Discussion: Patient satisfaction with the OSIA implant was already very high after the first fitting of the processor. The hearing impression with the OSIA confirms the preoperative hearing impression with the SoundArc. The SoundArc wearing test proved to be a reliable prediction method for the hearing impression with the OSIA.Einleitung: Das OSIA OSI 200 ist ein neues implantierbares Knochenleitungs-Hörsystem, das Schallvibrationen mittels Piezo-Technologie an das Innenohr überträgt. Das Implantat (BI300) ist mit einem Knochenleitungsimplantat verbunden. Der SoundArc ist ein Bügel zur Befestigung von Soundprozessoren und bietet eine nicht-chirurgische Trageoption. Die vorliegende Studie untersucht, wie der präoperative Trageversuch mit SoundArc das Hörvermögen mit dem OSIA vorhersagen kann. Methoden: In der Studie erhielten 19 Patienten insgesamt 20 OSIA-Implantate, wobei das Durchschnittsalter 56 Jahre betrug. Die Indikationen reichten von kombinierter Schwerhörigkeit nach Tympanoplastik bis mittelgradiger Innenohrschwerhörigkeit mit problematischer Hörgeräteversorgung bei rezidivierender Otitis externa und/oder Psoriasis. Das präoperative Einsilberverständnis mittels SoundArc wurde bei 65 und 80 dB im Sprachaudiogramm erfasst und mit dem Hörergebnis nach der OSIA-Anpassung verglichen. Die Patientenzufriedenheit und die Übereinstimmung des Höreindrucks zwischen OSIA und SoundArc wurden ebenfalls untersucht. Ergebnisse: Die Cochlear OSIA OSI200 Implantat-Operationen verlief problemlos. Alle Patienten waren mit dem Höreindruck des OSIA zufrieden. Der Höreindruck mit OSIA stimmte mit dem erwarteten Höreindruck mittels SoundArc überein. Bei der Einsilberverständlichkeit erzielten einige Patienten bessere Ergebnisse mit dem OSIA, während andere mit dem SoundArc besser abschnitten. Diskussion: Die Patientenzufriedenheit mit dem OSIA-Implantat war nach der ersten Anpassung des Prozessors bereits sehr hoch. Der Höreindruck mit dem OSIA bestätigt den präoperativen Höreindruck mit dem SoundArc. Der SoundArc Trageversuch erwies sich als zuverlässige Vorhersagemethode für den Höreindruck mit dem OSIA.Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht.

Dr. rer. nat.

In vivo measurements of contralateral crosstalk in fully implantable hearing systems

In-vivo-Messung kontralateralen Übersprechens bei vollständig implantierbaren Hörsystemen

Introduction Recipients of hearing implants such as cochlea implants or active middle ear implants (AMEI) are often contralaterally treated with a conventional hearing aid. These are capable of delivering amplified sound exceeding 100 dB SPL into the ear canal. Development of fully implantable devices must take into account a possible crosstalk between the contralateral hearing aid and the implanted microphone. At our clinic, nearly 50 patients were recently implanted with a CARINA fully implantable AMEI – a rare opportunity to study the sound transmission through the skull with an implanted sensor in vivo. Materials and Methods 18 Participants were recruited from patients with a CARINA implant on one side and an intact outer ear morphology contralaterally. We measured transfer functions from 4 actuators to 4 sensors at various points on the skull. Main focus was the sound transfer from a contralateral in-ear speaker to the ipsilaterally implanted subcutaneous microphone, with sound pressure directly above the microphone position as a reference. Results We find that on average, contralateral crosstalk to the subcutaneous microphone was about 30 dB below ipsilateral sound coupling. Discussion According to current audiometric practice, interaural attenuation (crosstalk from airborne sound to the contralateral cochlea) is assumed to be about 50 dB above 1kHz. Our findings indicate that this may be exaggerated and may in fact be closer to 30 dB across frequencies. Therefore, these results are of interest not only for the development of implantable microphones but may also bear relevance to audiometric testing practices such as masking and air-bone gap measurements.Die Autoren geben an, dass kein Interessenkonflikt besteht.

Successful implantation of an active transcutaneous bone conduction implant system in 3-year-old children

Erfolgreiche Transplantation eines aktiven transkutanen Knochenleitungssystems in dreijährigen Kindern

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. Methodology: 3-year-old children with aural atresia were implanted with the second generation of the Bonebridge. Preoperative Workup comprised a CT scan, a MRI scan, and an ABR (bone and air conduction). The computed tomography was performed to measure bone thickness and to determine the consistency of the temporal bone using the Otoplan software in order to find the optimal position for the implant. Results: All patients were successfully implanted. No severe adverse effects were observed. All showed a good postoperative hearing performance. Discussion: With adequate preoperative workup and planning, this device can be safely implanted in 3-year-old children with a beneficial postoperative audiological outcome and without adverse effects.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. Methoden: Dreijährigen Patienten mit Gehörgangsatresie wurde die zweite Generation des Bonebridge BC 602 implantiert. Die präoperative Diagnostik umfasste ein CT des Felsenbeins, eine MRT und eine BERA (in Luft- und Knochenleitung). Die Computertomographie erfolgte zur Bestimmung der Knochendicke und der optimalen Implantatposition unter zusätzlicher Verwendung der Otoplan Software. Ergebnisse: Die Implantation wurde bei allen Patienten erfolgreich durchgeführt. Es traten keine wesentlichen Komplikationen auf. Alle Patienten zeigten gute postoperative Hörergebnisse. Diskussion: Mit guter präoperativer Diagnostik und Planung kann dieses System auch bei dreijährigen Kindern ohne wesentliche Komplikationen implantiert werden und führt zu einem guten postoperativen Hörergebnis.Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht.

M.Sc.

PD Dr.

First audiological results with the novel active bone conduction implant Sentio in SSD patients

Erste audiologische Ergebnisse mit dem neuen aktiven Knochenleitungsimplantat Sentio in Patienten mit einseitiger Taubheit

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. Method: Five patients between 25 and 58 years of age with SSD and a normal hearing contralateral ear (bone conduction PTA4 9.0 ± 3.2 dB HL and air conduction PTA4 9.5 ± 2.9 dB HL) were implanted with the Sentio TI between April and October 2023. Four of the five patients were already fitted with the Sentio 1 processor. A first analysis of clinical outcome data was based on unaided and aided sound field audiograms with the contralateral ear muffled and plugged and the word recognition scores (in %) in quiet using the German Freiburg monosyllable test. Results: Average pure-tone thresholds improved substantially from 58.8 ± 2.5 dB HL in unaided condition to 21.5 ± 1.6 dB HL aided with the Sentio. The average word recognition in quiet of all five patients was 0% preoperative and 98.8% with the Sentio (n=4). The Sentio is well received by the patients and the subjective benefit and satisfaction is high. Discussion: First results indicate an improvement in speech perception in quiet and satisfaction with the Sentio system in patients with SSD.The institution is paid by Oticon Medical AB to perform the research.

Clinical implementation of individualized drug-releasing external ear canal implants for prevention of postoperative external ear canal restenosis

Mittelohr

Klinische Umsetzung individualisierter, medikamentenfreisetzender Implantate zur Prävention postoperativer Stenosen des äußeren Gehörgangs

Background: Reducing the incidence of postoperative external ear canal (EEC) stenosis is crucial after canaloplasties. To explore an innovative solution, we developed three-dimensionally (3D) printed, patient-individualized, drug-releasing external ear canal implants (EECI) as postoperative stents, loaded with dexamethasone (DEX) and ciprofloxacin (cipro). Methods: EECI models were manually segmented from temporal bone cone beam computed tomography images and 3D printed using medical-grade UV silicone (60A MG, BIO-83-6001, EnvisionTEC, silicone elastomer curing at 365 nm, USP Class VI). The implants were loaded with DEX and cipro, and pre-clinically tested for drug release, biocompatibility, bio-efficacy, and microbial contamination. Subsequently, individualized EECI were implanted in three patients with congenital EEC atresia, postoperatively acquired EEC stenosis, or EEC restenosis after multiple canaloplasties. Results: Preclinical tests confirmed drug release and demonstrated no cytotoxic effects. The UV silicone EECI exhibited anti-inflammatory and antibacterial effects without microbial contamination. Implantation in three patients showed ease of insertion and postoperative explantation at three months with no otogenic symptoms or infections during follow-up visits. Even 12 months postoperatively, the EECs exhibited good epithelialization and patency. Conclusion: Our study demonstrates the clinical viability of individualized, mechanically flexible, drug-releasing EECI for preventing postoperative EEC restenosis. Ongoing research involving a larger patient cohort aims to further validate the effectiveness and safety of this novel EECI therapy, providing comprehensive and robust results. Keywords: ear canal stenosis; personalized implant; drug eluting implant; additive manufacturingHintergrund: Reduktion postoperativer Stenosen des äußeren Gehörgangs (EGC) ist nach Canaloplastiken entscheidend. Ziel: Machbarkeit dreidimensionaler, medikamentenfreisetzender Implantate (DEX, Cipro) als postoperative Stents. Methoden: EECI-Modelle manuell aus Digitalen Volumentomographie-Bildern (DVT) segmentiert, mit medizinischem UV-Silikon 3D-gedruckt. Implantate mit DEX und Cipro beladen, präklinisch getestet. Anschließend EECI bei drei Patienten implantiert. Ergebnisse: Präklinische Tests bestätigten Medikamentenfreisetzung ohne Zytotoxizität. EECI zeigten entzündungshemmende, antibakterielle Effekte ohne Kontamination. Implantation und explantation verliefen komplikationsfrei. Nach 12 Monaten gute Epithelialisierung und Offenheit. Schlussfolgerungen: Klinische Umsetzung individualisierter, medikamentenfreisetzender EECI stellt sichere Methode zur postoperativen Stentung dar. Schlüsselwörter: Gehörgangsstenose; personalisiertes Implantat; medikamentenfreisetzendes Implantat; additive Fertigung---

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Otologie – Mittelohrimplantate

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Graphical Glimpse 3Otologie – Mittelohrimplantate

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Otologie – Mittelohrimplantate