La surdité est un problème de santé publique. Le vieillissement de la population explique ainsi une grande partie des causes de surdités, par la fréquence de la presbyacousie. Le principal moyen de la réhabilitation auditive est représenté par les prothèses auditives conventionnelles. Les aides auditives ont considérablement progressé ces dernières années, principalement en termes d’amélioration du traitement du signal. Ceci étant dit, outre le problème économique, certains facteurs limitent encore les bénéfices que les patients peuvent ressentir (occlusion du conduit auditif, effet larsen, absence d’amplification en ambiance sonore,…). Les implants d’oreille moyenne sont destinés à amplifier le signal sonore en le transmettant à l’oreille moyenne pour compenser une perte auditive. Ils sont indiqués en cas d’échec ou de contre-indication de l’appareillage conventionnel. Cependant, les implants d’oreille moyenne présentent certaines limites comme l’insuffisance de performance. Des données récentes montrent que les performances des techniques de réparation de la chaîne ossiculaire sont dépendantes du couplage des prothèses ossiculaires à la chaîne des osselets. Par ailleurs, des avancées dans la compréhension de la biomécanique de la chaîne ossiculaire confirment l’importance du placement et du couplage des procédés de restauration chirurgicaux. Nous avons formulé l’hypothèse selon laquelle ces données pouvaient être appliquées aux implants d’oreille moyenne pour en améliorer les performances. Nous avons voulu analyser expérimentalement les effets sur les performances de variables telles que : placement d’un transducteur, le couplage à la chaîne des osselets, la taille de l’effecteur, l’effet de stimulations alternatives. Nous avons utilisé un transducteur électromagnétique de dernière génération (Otologics MET-V Gen 2) et une technique d’analyse de la vibration des structures de l’oreille moyenne par vélocimétrie laser. Les résultats ont montré une nette amélioration des performances en fonction des modifications de placement et de couplage à la chaîne des osselets ou à la fenêtre ronde. / Hearing loss is a public health issue. Ageing is the most frequent cause of deafness. The main option for the rehabilitation of hearing loss is the use of conventional hearing aids. These aids have dramatically improved their performance for the past 20 years, mostly with regards to signal processing. However, in addition to economic reasons, some limitations remain (occlusion, feedback, hearing in noise…) and limit the satisfaction of patients. Active middle ear implants (AMEI) have been developed to overcome some of these problems and are indicated n conventional hearing failed to improve patients’ quality of hearing. However, AMEI suffer from limitations, as insufficient performances for severe hearing losses. Recent experimental and clinical data have highlighted the importance of coupling and placement of ossicular reconstruction passive prosthesis use. Other reported new findings regarding the biomechanism of the ossicular chain, especially for high frequency hearing, which is, unfortunately, where most people have their hearing loss. We hypothesized that these findings could be applied to AMEI use. We have analysed experimentally the effects on AMEI performance of variables such as: placement, coupling, size of tranduscer vibrating tip, alternative stimulation options. We used a electromagnetic tranducer from Otologics LLC to drive the middle ear or round window membrane, and a laser Doppler vibrometer to assess for the induced middle transfer function. Results have shown that we could provide great improvement in performance when varying the coupling method and the placement to the ossicular chain or the round window membrane.

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 evaluate 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.

Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warbletone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT 50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA) quality-of-life questionnaire was scored very positively by all patients. Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery.

Although the Vibrant Soundbridge is one of the most frequently used active middle ear implants, data regarding how middle ear ventilation disorders may affect the transmission behavior of its floating mass transducer are still insufficient. Studies involving coupling the floating mass transducer to the stapes head are particularly lacking. This temporal bone study evaluated the influence of simulated middle ear ventilation disorders on the middle ear transfer function in the reconstructed middle ear. The middle ear transfer function was measured using Laser Doppler Vibrometry after vibroplasty onto the stapes head, with or without tympanic membrane reconstruction. Middle ear ventilation disorders were simulated through changes in static pressure via the external ear channel with a maximum pressure of þ3 kPa. Slice thickness of tympanic membrane reconstruction material was measured using micro-CT. When the reconstructed ossicular chain and the reconstructed tympanic membrane were mechanically excited by the floating mass transducer under conditions of ambient static pressure, the transmission behavior was found to be independent of the type of tissue used. Increase in static pressure up to þ3 kPa caused maximum low frequency transmission loss of 15 dB when elastic grafts were used and 5 dB when stiff tissue was inserted. At high frequencies, measured loss of up to 5 dB was relatively independent of the tissue stiffness. Increase in static pressure led to displacement of the tissues towards the vestibulum and caused stiffening, especially of the annular ligament. Stiffening-induced transmission losses were mainly found at low frequencies and could not be compensated by the floating mass transducer in this range. Above 1300 Hz, the continuous force spectrum of the actuator sufficiently protected against loss of amplitude. To minimize postoperative transmission loss due to persisting ventilation disorders, choosing a very stiff tympanic membrane reconstruction material seems to be appropriate.:Inhaltsverzeichnis Abkürzungsverzeichnis V 1 Einleitung 1 1.1 Einführung 1 1.2 Operationen zur Hörverbesserung 2 1.3 Mittelohrimplantate 6 1.4 Belüftungsstörungen des Mittelohres 12 1.5 Fragestellungen, Forschungshypothesen und Zielstellung der Arbeit 18 2 Material und Methoden 20 2.1 Laserdopplervibrometrische Messungen am Felsenbeinpräparat 20 2.2 Untersuchung der Trommelfellersatzmaterialien mittels optischer Messverfahren 3 Ergebnisse 42 3.1 Ermittelung der Trommelfellersatzmaterialdicken und -steifigkeiten mittels optischer Messverfahren 42 3.2 Messung der Mittelohrübertragungsfunktion am Felsenbeinpräparat 62 4 Diskussion 104 4.1 Bestimmung der Trommelfellersatzmaterialdicken und -steifigkeiten mittels optischer Messverfahren 104 4.2 Messung der Mittelohrübertragungsfunktion am Felsenbeinpräparat 110 4.3 Ausblick und Konsequenzen der Untersuchungen zur Paukenminderbelüftung auf die Vibroplastik und die Tympanoplastik Typ III 131 4.4 Funktionelles Hörergebnis nach Implantation einer VSB beim Vorliegen einer Schallleitungsschwerhörigkeit oder kombinierten Schwerhörigkeit 133 4.5 Schlussfolgerung 134

Background: Some patients with chronic middle ear disease and multiple failed revisions, who also need a hearing aid, may benefit from an active middle ear implant. An advantage of an active middle ear implant is that the ear canal is unoccluded. Methods: Following extensive experimental development in temporal bones and investigations of various locations and attachments of a Vibrant Soundbridge transducer, a new titanium clip holder for the vibrant floating mass transducer was developed. This assembly is a total ossicular replacement prosthesis (TORP) that is placed on the stapes footplate. Six patients were implanted with this device. Results: Acoustic results demonstrate significantly improved gain, especially in the high frequencies, which is typically unobtainable by conventional hearing aids. Conclusion: The simple procedure of placing an active TORP assembly on the stapes footplate, similar to the implantation of a passive TORP prosthesis during tympanoplasty, offers promising treatment for cases of incurable middle ear disease. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.