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Objective: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant., Methods: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects., Results: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively., Conclusion: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery., (© 2019 S. Karger AG, Basel.)

There is currently no standardized method for reporting audiological, surgical and subjective outcome measures in clinical trials with active middle ear implants (AMEIs). It is often difficult to compare studies due to data incompatibility and to perform meta-analyses across different centres is almost impossible. A committee of ENT and audiological experts from Germany, Austria and Switzerland decided to address this issue by developing new minimal standards for reporting the outcomes of AMEI clinical trials. The consensus presented here aims to provide a recommendation to enable better inter-study comparability., (The Author(s). Published by S. Karger AG, Basel.)

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 BCI, while percutaneous BCI systems are recommended also for moderate hearing loss. For combined hearing loss 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., (© Georg Thieme Verlag KG Stuttgart · New York.)

The training of microsurgical motor skills is essentiell for surgical education if the interests of the patient are to be safeguarded. In otosurgery the complex anatomy of the temporal bone and variations necessitate a special training before performing surgery on a patient. We therefore developed and evaluated a simplified middle ear model for acquiring first microsurgical skills in tympanoplasty.The simplified tympanoplasty model consists of the outer ear canal and a tympanic cavity. A stapes model is placed in projection of the upper posterior tympanic membrane quadrant at the medial wall of the simulated tympanic cavity. To imitate the annular ligament flexibility the stapes is fixed on a soft plastic pad. 41 subjects evaluated the model´s anatomical analogy, the comparability to the real surgical situation and the general model properties the using a special questionnaire.The tympanoplasty model was very well evaluated by all participants. It is a reasonably priced model and a useful tool in microsurgical skills training. Thereby, it closes the gap between theoretical training and real operation conditions., (© Georg Thieme Verlag KG Stuttgart · New York.)

Active middle ear implants do not produce acoustic sounds but, rather, micromechanical vibrations. The stimulating signal does not leave the transducer as sound, but as a mechanical vibration, directly coupled to the auditory system and bypassing the normal route via air. In this paper, we review our experience with the TICA and the Carina middle ear implants. Both are totally implantable and are coupled to the ossicular chain or to perilymph. The design requirements for electronic hearing implants for patients with conductive hearing loss differ from those for sensorineural hearing loss. Conductive hearing loss requires an implant that replaces impedance transformation and acts as an impedance transforming implant (ITI). In many respects, there are fewer demands on an ITI than on an electronic hearing aid for patients with sensorineural hearing loss., (Copyright (c) 2010 S. Karger AG, Basel.)

Despite the wide variety of ossiculoplasty techniques that are available, success rates are limited. Current use indicates that surgeons prefer ceramic, autograft bone, and plastic pore prostheses. During the past decade, titanium prostheses have been used with great promise. Although their use is not widespread, satisfaction rates are high. An earlier study of ossiculoplasty showed that titanium prostheses were effective in reducing conductive hearing loss. To date, the surgical-handling attributes of titanium middle ear prostheses have not been assessed. We report the results of our survey of 32 otologic surgeons who used the open Tübingen titanium prosthesis for primary and revision ossiculoplasty during tympanoplasty in 400 patients at 12 academic and nonacademic otolaryngology clinics, most of them in Germany. Because the audiometric efficacy of titanium prostheses has been previously reported, our primary outcomes measures included ease of use with respect to the amount of time required to prepare the implants for placement and the surgeons' overall impression of the intraoperative handling characteristics of the implants, taking into consideration factors such as positioning, length adjustment, visibility, and the stability of the coupling. Surgeons also compared the properties of the titanium implant with those of gold, ceramic, and autograft implants that they had used in the past. Based on the results of 383 of the 400 ossiculoplasties, our survey revealed that the titanium implant was significantly superior to the others in all measured respects.