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Surgical treatment with bone conduction hearing implants and epitheses for ear malformations offer the right combination of hearing rehabilitation and cosmetic reconstruction. The surgical procedure is often performed in two-stage surgical steps. This project aimed to gain experience with a procedure in which the hearing implant and the epithesis anchors are inserted simultaneously. Four ears of three patients (n All patients scored 4 points each in the aMEI-score, indicating an unfavorable prognosis for successful implantation of an active middle ear implant. The treatment with a Bonebridge and an epithesis anchor was performed without complications. Postoperatively, the initial audiological fitting and the application of the magnetic abutment were performed after 4 weeks. Audiometry showed a functional gain of up to 30 dB and an improved speech comprehension. The epithesis was shaped like the contralateral ear. After treatment, patients were satisfied with the audiological and cosmetic results. The simultaneous surgical procedure with a bone conduction hearing implant and epithesis anchor is a good option for the treatment of ear malformations. The aMEI-score was a helpful instrument for the indication. The procedure reduced the surgical risk and the time and effort required for treatment. Die chirurgische Versorgung mit einem Hörimplantat und Epithesen bei Ohrmissbildungen bietet eine gute Kombination aus Hörrehabilitation und kosmetischer Rekonstruktion. Oft wird die Versorgung in 2-zeitigen Operationsschritten durchgeführt. Ziel der Arbeit war es, Erfahrungswerte mit einem Vorgehen zu gewinnen, bei dem das Hörimplantat und die Epithesenanker simultan eingesetzt werden. Vier Ohren von 3 Patienten (n Alle Patienten erzielten jeweils 4 Punkte im aMEI-Score, was auf eine ungünstige Prognose für eine erfolgreiche Implantation eines aktiven Mittelohrimplantats hinwies. Die Versorgung mit der Bonebridge und einem Epithesenanker konnte daraufhin komplikationslos durchgeführt werden. Postoperativ erfolgten nach 4 Wochen die audiologische Erstanpassung und die Bestückung mit Magneten. In der Audiometrie bestand ein funktioneller Gewinn von bis zu 30 dB sowie ein verbessertes Sprachverständnis. Die Epithese wurde dem gesunden Ohr nachgebildet. Nach der Versorgung waren die Patienten mit dem audiologischen und kosmetischen Ergebnis zufrieden. Das simultane chirurgische Vorgehen mit einem Hörimplantat und Epithesenankern stellt eine gute Option in der Versorgung von Ohrmissbildungen dar. Der aMEI-Score war ein hilfreiches Instrument zur Indikationsstellung. Durch das Vorgehen konnten das Operationsrisiko und der Aufwand der Versorgung reduziert werden.

Different bone conduction hearing aids (BCHA) are commercially available. They are attached to the head in different ways. The aim of this work is an experimental evaluation of the performance of a new transcutaneous (surface mounted via adhesive pad) actuator of a BCHA.Experiments were conducted on a Thiel embalmed whole head cadaver specimen. The electromagnetic actuators from a commercial BCHA (Adhear) was used to provide stepped sine stimulus in the range of 0.1-10 kHz. The BCHA was coupled to a skin surface adhesion that was placed on the mastoid. The response was monitored as motions of the ipsi- and contralateral promontory, and as motions of the ipsi-, top- and contralateral skull surface. Promontory motion was quantified via a three-dimensional laser Doppler vibrometer (3D LDV) system. Analogously, surface motion was registered by sequentially measuring ~200 points on the skull surface (~ 15-20 mm pitch) via 3D LDV. The data were compared to corresponding measurements obtained with a Baha Power that was coupled to skin on the Mastoid via a 5 Newton steelband.Ipsilateral and contralateral promontory vibration for stimulation with the Adhear are comparable to stimulation with the Baha Power on the 5 Newton steelband with regard to frequency dependent amplitude and phase, as well as the contribution of the motion components. The surface motion of the skull experiences a similar complex motion for both stimulation modes.Although the Adhear is coupled without any pressure to the skin over the mastoid whereas the Baha power is attached with a 5 Newton steelband, the vibration parameters investigated are comparable.Es sind unterschiedliche Knochenleitungshörgeräte (KLHG) verfügbar, die auf unterschiedliche Art mit dem Stimulationsort in Kontakt stehen. Ziel dieser Arbeit ist eine experimentelle Evaluation eines neuen transkutanen KLHG, das ohne Anpressdruck an die Haut angekoppelt wird.Die Messungen wurden an einem Thiel-konservierten Ganzkopfkadaver durchgeführt. Zur Stimulation zwischen 0,1 und 10 kHz wurde ein Adhear verwendet, das über einen Signalgenerator und Verstärker direkt mit 1Vrms aktiviert wurde. Die Kopplung des KLHG erfolgte am Mastoid über ein Hautpflaster. Die Vibrationen des Schädels wurden am ipsi- und kontralateralen Promontorium und an der ipsi-, top- und kontralateralen Schädeloberfläche mittels 3D-Laser-Doppler-Vibrometers registriert. Insgesamt wurden ~200 Punkte auf der Schädeloberfläche (~15–20 mm Abstand) gemessen. Die Daten wurden mit entsprechenden Messungen verglichen, bei denen ein Baha Power als KLHG verwendet wurde. Dieses wurde am Mastoid über einen 5-Newton-Stahlbügel an die Haut gekoppelt.Die ipsi- und kontralateralen promontorialen Vibrationen bei Stimulation mit dem Adhear sind in ihrer frequenzspezifischen Amplitude und Phase wie auch in der Zusammensetzung der Bewegungskomponenten mit der Stimulation mittels Baha Power am Stahlbügel vergleichbar. Ebenso erfährt die Schädeloberfläche unter beiden Ankopplungsarten eine vergleichbare komplexe räumliche Bewegung.Obwohl das Adhear ohne Anpressdruck und das Baha Power am Stahlband mit 5N an die Haut über dem Mastoid gekoppelt werden, unterscheiden sich die untersuchten Parameter kaum.

Here, we describe the surgical technique for implanting a new, active, transcutaneous bone conduction hearing aid. The implant technology is based on a system that has been in use reliably since 2012. The geometry of the new implant has been adapted based on experience with previously introduced implants. The surgery was feasible, standardized, and safe. Due to the optimized geometric design that improved the bone fit, it is not necessary to use specialized, detailed preoperative planning, except in challenging anatomical conditions; e.g., in young children, malformations, poor pneumatization, or after a canal wall down mastoidectomy.Im vorliegenden Beitrag wird die Technik der Implantation eines neuen aktiven, transkutanen, knochenverankerten Hörimplantats beschrieben. Das Hörimplantat basiert technisch auf einem System, das bereits seit 2012 zuverlässig im Einsatz ist. Die Geometrie des neuen Systems ist an die Erfahrungen mit vorangegangenen Implantaten angepasst. Die Op. ist standardisiert und sicher durchführbar. Aufgrund der optimierten Bauform mit verbesserter Passfähigkeit im Schläfenbein erscheint eine spezielle, detaillierte präoperative Planung der Implantation nur noch in Fällen mit besonderen anatomischen Gegebenheiten, wie z. B. bei Kindern, bei Fehlbildungen, bei schlechter Pneumatisation des Schläfenbeins und nach Anlage einer offenen Mastoidhöhle notwendig.

A multitude of new implantable hearing systems and applications creates new options for pathologies which have been difficult to treat in the past. For many of these hearing systems preclinical technical methods to characterize devices and applications are limited. Therefore, clearly structured clinical investigations and trials are necessary to render results of devices and applications comparable for meta-analysis. Beside optimizing results in current applications, this is also essential for comparisons with established treatment options and differential indication criteria. Even during planning and design of studies, the timing of reference measurements and the choice of-on-off vs. pre-post comparisons in audiological testing decides the focus of the study. This applies equally to the choice for a monaural vs. a binaural test design, which decides whether the study will have the device or the overall result of the treatment in focus. Additional measures such as effective gain, coupling efficiency, and maximal possible intelligibility (WRSEine Vielzahl neuer implantierbarer Hörsysteme und Anwendungen eröffnet zusätzliche Möglichkeiten für bisher schlecht behandelbare Erkrankungen. Für viele dieser Hörsysteme gibt es nur eingeschränkt technische Möglichkeiten, um alle Anwendungen technisch zu charakterisieren. Deswegen sind klar strukturierte, klinische Studien, die die Anwendungen und Geräte für zusammenfassende Metastudien vergleichbar machen, dringend erforderlich. Dies ist nicht nur im Hinblick auf die Optimierung von implantierbaren Hörsystemen und ihren Anwendungen von zentraler Bedeutung, sondern auch für die Vergleichbarkeit mit etablierten Versorgungsformen und Differenzialindikationskriterien notwendig. Schon bei der Planung von Studien ist die Wahl der Referenzzeitpunkte und die Wahl, ob man einen Vorher-nachher-Vergleich oder postoperativen Vergleich mit an- und ausgeschaltetem Gerät macht, für die Aussage der audiometrischen Ergebnisse entscheidend. Auch ist die Frage, ob ein monaurales oder seitengetrenntes Studiendesign gewählt wird, entscheidend dafür, ob man das Gerät oder den Behandlungserfolg im Auge haben will. Zusätzliche Maße, wie z. B. „effective gain“, „coupling efficiency“ und maximal mögliches Sprachverstehen (WRS

Implantable hearing systems work because mechanical vibration energy is introduced into the hearing system. The performance of the hearing system is thus essentially determined by physical parameters. Together with the tone and speech audiogram the indications for deciding on a system are based on the efficacy of the respective system and the patient's wishes. Hearing-assisted patients should have a dynamic range of 30-35 dB to adequately understand speech. This should be guaranteed with the respective system also in the medium to long term. In addition, sufficient cochlear reserve performance for implantable hearing systems is critical for success. The expected and achieved audiological success can be the effective gain as a difference of aided hearing threshold to bone conduction threshold and should be preferred to the unreflecting use of gain or functional gain. With good differential diagnostic indications and the inclusion of conventional hearing aids and cochlear implants, optimal hearing solutions can be found for almost all patients.Implantierbare Hörsysteme funktionieren, weil mechanische Schwingungsenergie in das Hörsystem eingebracht wird. Die Leistungsfähigkeit der Hörsysteme wird also wesentlich durch physikalische Parameter bestimmt. Zusammen mit dem Ton- und Sprachaudiogramm bestimmen die Leistungsfähigkeit des jeweiligen Systems und der Patientenwunsch die Indikationsstellung. Mit Hörsystemen versorgte Patienten sollen einen Dynamikbereich von 30–35 dB (Dezibel) zur Verfügung haben, um ausreichend Sprache verstehen zu können. Dies sollte mit dem jeweiligen System auch mittel- bis langfristig garantiert werden können. Zudem ist eine ausreichende Leistungsfähigkeit der Cochlea („cochleäre Reserve“) für implantierbare Hörsysteme erfolgsentscheidend. Der zu erwartende und erreichte audiologische Erfolg lässt sich dem Effective Gain als Differenz der Hörschwelle mit Hörsystem zur Knochenleitung gut messen und sollte der unreflektierten Verwendung des Gain bzw. Functional Gain bevorzugt werden. Bei guter Differenzialindikation und unter Einbeziehung konventioneller Hörgeräte und Cochleaimplantate lassen sich für fast alle Patienten optimale Hörlösungen finden.

Bone conduction hearing aids can be worn as noninvasive devices using a clip or soft band that exerts pressure on the skin, or they can be surgically implanted. ADHEAR (MED-EL GmbH, Innsbruck, Austria) is a novel noninvasive bone conduction hearing aid that is attached behind the ear using an adhesive adapter and does not exert pressure on the skin. ADHEAR is indicated for patients with conductive hearing loss and normal inner ear function. The aim of this study was to evaluate the achievable hearing improvement with ADHEAR.Twelve subjects with normal hearing participated in this study. To mimic conductive hearing loss, the participants' ear canals were occluded unilaterally with a foam ear plug. The resultant conductive hearing loss was assessed with pure tone air- and bone-conduction threshold audiometry. Hearing ability was tested with and without ADHEAR via free-field tone audiometry, number perception, and monosyllable perception, with the contralateral ear plugged depending on test requirements.Using ADHEAR, the free-field hearing threshold improved by 13.7 dB at 500 Hz, by 17.9 dB at 1 kHz, by 17.2 dB at 2 kHz, and by 9.8 dB at 4 kHz. In the higher frequencies, a significant pure-tone gain of 14.4 dB at 6 kHz and of 16.5 dB at 8 kHz was observed. Number perception with ADHEAR was mean 69.2% at 35 dB, 97.9% at 50 dB, 100% at 65 dB, and 100% at 80 dB. Monosyllable perception with the ADHEAR was mean 35.0% at 35 dB, 72.3% at 50 dB, 93.5% at 65 dB, and 98.8% at 80 dB.Hearing performance was significantly better with ADHEAR under all test conditions except those where maximum perception was already achieved without ADHEAR.

Combined hearing loss is an essential indication for implantable hearing systems. Depending on the bone conduction threshold, various options are available. Patients with mild sensorineural deafness usually benefit from transcutaneous bone conduction implants (BCI), while percutaneous BCI systems are recommended also for moderate hearing loss. For combined hearing losses with moderate and high-grade cochlear hearing loss, active middle ear implants are recommended. For patients with incompatibilities or middle ear surgery, implants are a valuable and proven addition to the therapeutic options., GMS Current Topics in Otorhinolaryngology - Head and Neck Surgery; 16:Doc06

The identification and treatment of hearing disorders belong to the fundamental tasks of an ENT-specialist. In this context the fitting of hearing aids has a special relevance. To verify a highly qualified medical care the knowledge of the audiological threshold values for the indication of the fitting of hearing aids and the detection of early signs for impaired communication are essential. The current quality assurance agreement defines technical and steric conditions pertaining to hearing aid fitting in the context of statutory health insurance. Only after approval of these postulated requirements the attending physician is allowed to bring to account his effort. The current regulations on medical devices specify both the basic requirement for a medical prescription and the expenses for hearing aids that are covered by the healthy insurances. A qualified hearing aid fitting is only possible if the ENT-specialist not only prescribes the device, but also conscientiously checks the comparative adjustments made by the hearing aid acoustician. Beside the knowledge about the general mode of operation and the different types of hearing aids ENT-specialist should know audiological and anatomic limits for the fitting of hearing aids.

In case of audiological and/or anatomical limitations in the provision of conventional hearing aids, semi- or fully-implantable hearing systems represent a modern therapy alternative. These hearing systems are divided according to their mode of action into active middle ear implants when stimulating the auditory ossicles or the round window, into bone conduction devices while stimulating the skull directly, into cochlear implants with direct acoustic stimulation to the cochlea with its auditory nerve and finally into auditory brainstem implants by bridging the peripheral auditory structures. Taking careful criteria of indications and anatomical specificities into account, significant improvements can be achieved in comfort, speech understanding and thus quality of life for a large number of patients.

The majority of patients with moderate to severe hearing loss can be supplied with conventional hearing aids depending on severity and cause for hearing loss in a satisfying way. However, some patients either do not benefit enough from conventional hearing aids or cannot wear them due to inflammatory reactions and chronic infections of the external auditory canal or due to anatomical reasons. For these patients there are fully- and semi-implantable middle ear and bone conduction implants available. These devices either directly stimulate the skull (bone conduction devices), middle ear structures (active middle ear implants) or the cochlea itself (direct acoustic stimulation). Patients who failed surgical hearing rehabilitation or do not benefit from conventional hearing aids may achieve a significant better speech understanding and tremendous improvement in quality of life by implantable hearing devices with careful attention to the audiological and anatomical indication criteria.

Various different hearing systems are available for device-supported hearing rehabilitation of patients with mixed hearing loss. Using the recently introduced objective comparison criterion "maximum output" (i.e., the maximum output level of a hearing device), the indications for different hearing devices can be compared.This article reviews important terms such as gain, dynamic range, and maximum output level-all of which are relevant for the selection of a hearing device. The experimental part of this study compares all currently available hearing devices and determines the range of their indication with respect to the maximum bone-conduction hearing threshold.The maximum frequency-specific output levels reported in the literature for the Baha Cordelle 2, the Sophono Alpha 2, and the Bonebridge (measured at the skull simulator), as well as those of the Codacs and the Soundbridge (in-vivo measurements) are compared to the maximum output levels given in the datasheets of the BP110 Power, the Baha Cordelle 2, the Bonebridge, the Codacs, the Ponto Pro Power, and the Sophono Alpha 2. Using appropriate correction factors, the maximum dynamic range and thus the maximum indication based on the bone-conduction threshold was determined.In patients with mild sensorineural hearing loss, passive transcutaneous hearing or Bonebridge implants can achieve good audiological results. In the transition region to moderate hearing loss, percutaneous devices are applicable. Combined hearing loss with more pronounced sensorineural hearing loss is best treated with a Soundbridge or Codacs implant. In the latter case, the cochlear potential for speech recognition has to be explored and, where appropriate, cochlear implants considered as an alternative.

Implantable hearing aids are not only gaining importance for the treatment of sensorineural hearing loss, but also for treatment of mixed hearing loss. The most frequently used active middle ear implant is the Vibrant Soundbridge (VSB) system (Fa. MED-EL, Innsbruck, Österrreich). Following widening of the spectrum of indications for the VBS, various new coupling systems have been established. Based on the literature, available petrosal bone investigations and finite element model (FEM) calculations, this article summarizes the current knowledge concerning mechanical excitation by the VSB. Important concomitant aspects related to coupling, transmission and measurement are also discussed.

Patients with air-bone gaps or combined hearing loss that cannot be corrected by tympanoplasty can be treated with bone conduction hearing aids. The disadvantages of conventional and percutaneous systems are, on one hand, the obvious external fixation components and on the other hand, the biological and psychosocial problems of open implants. This project was therefore set up to develop a semi-implantable, magnetically anchored transcutaneous bone conduction device, introduce it into clinical application and follow-up the results.The principle of this bone conduction device is the magnetic coupling of an external vibrator via implanted double magnets. After extensive laboratory tests, this method was introduced into the clinic in 2006. Following the initial pilot study, 184 implantations in 143 patients have been performed in Recklinghausen since 2008. Long-term evaluation of 20 congenital atresia patients treated with these devices was possible.Worldwide, more than 3000 of these devices have been implanted. The operative implantation technique is relatively simple. With the new "upside down technique", bone removal is no longer necessary. The 2.6-mm thin implants are hardly noticeable. The hearing improvement is similar to that of other bone conduction hearing aids.This semi-implantable transcutaneous bone conduction hearing device is another option for patients with air-bone gaps, combined hearing loss or single-sided deafness.

Active implantable hearing devices were primarily developed for sensorineural hearing loss. The vibrator coupling mechanisms were oriented towards normal middle ear anatomy and function. The aim of this project was to modify the only fully implantable hearing device with an implantable microphone for application in congenital auricular atresia, Carina™, and to introduce the modified device into the clinic. A special prosthesis was developed for the transducer and its individual coupling achieved by a special cramping system. The system was implanted in 5 patients with congenital auricular atresia. Audiological results were good; with patients' hearing gain exceeding 30 dB HL. Anatomic limits to the system's indications and technical drawbacks are also discussed.

Diverse forms of bone conduction devices (BCD; percutaneous or transcutaneous) provide successful and well-established therapies for conductional hearing loss (CHL). For patients in whom a surgical procedure is to be avoided for medical or personal reasons, instruments with head straps or bands, and bone conduction glasses are available. The current article presents and examines the audiological results of a newly developed, nonsurgical bone conducting device (C.A.I. BC811, bruckhoff hannover; C.A.I: Concha Anchored Instrument) that is fixed in the concha and transfers the sound to the cheekbone.In this cross-over study, 4 CHL patients with minimal sensorineural components and existing treatment with a BCD were supplied with a BC811. Audiological outcomes with the optimized existing device and the BC811 were evaluated and compared at 2-weekly intervals. In addition to the aided versus unaided sound field thresholds, the monosyllabic Freiburg intelligibility test, hearing in noise (OlSa) and the subjective benefit of the treatment (APHAB questionnaire) were investigated.No significant differences between BC811 and the optimized existing devices were found in terms of aided thresholds in sound field, functional gain or monosyllabic intelligibility tests. The average aided improvement of the threshold was PTA4 = 29.4 ± 11.1 dB (mean ± standard deviation) with the BC811. The improvements in the monosyllabic intelligibility and hearing in noise tests were significant for both types of device and comparison between the device types revealed no significant differences. The subjective ratings of the perceived improvement reflected by the global APHAB score were positive and similar: 36.4 (control) and 33.4 (BC811).The comparison with BCDs demonstrated that the BC811 is a realistic and audiologically sufficient alternative to surgical solutions using percutaneous devices for patients with CHL.

By virtue of direct bone conduction, percutaneous bone-anchored hearing implants offer a high level of wearing comfort, as well as audiologically superior signal transmission due to less dampening. Over the years, titanium implants have been optimized and the surgical technique developed into a minimally invasive intervention without soft tissue reduction. This study aims to investigate the success rates of the various percutaneous implant systems.This retrospective study includes 191 patients who received a total of 283 percutaneous titanium implants for bone conduction hearing systems during the period from 01.01.1989 until 31.12.2013. Patient age ranged from 2 to 81 years (mean 36 years). The mean follow-up duration was 5.2 years.The overall osseointegration success rate was 92.6% and ranged from 90.5 to 100% for the various implant systems (p = 0.6). For children and adolescents, the success rate was 86.8%, compared to 95.2% in adults (p = 0.023). Classical soft tissue reduction was received by 185 patients, mainly via the dermatome technique. The linear incision technique was used in 3.8% of cases and the technique without soft tissue reduction in 3.7% of cases. Revision surgery for soft tissue problems was performed in 4.2% of cases.Success rates in adults were significantly higher than those in children and adolescents. Although success rates improved with the development of new systems, this did not reach statistical significance. Minimally invasive surgery without soft tissue reduction is considered state of the art.