A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers

Abstract

Purpose To evaluate the safety and performance of three novel vibroplasty couplers that allow attachment of the floating mass transducer of a transcutaneous active middle ear implant (AMEI) to the round window (RW) membrane, the long process (LP), or the incus body and the short process (SP) of the incus. Methods Retrospective multicenter cohort study of 25 AMEI users with sensorineural or mixed hearing loss that were among the first implanted with an AMEI vibrating ossicular prosthesis in combination with the third generation of vibroplasty couplers between 2014 and 2016. Main Outcome Measures were bone-conduction pure-tone and vibroplasty thresholds, postoperative aided sound field thresholds and postoperative aided word recognition score (WRS). Results Bone conduction threshold changes of more than 10 dB in 4PTA BC were observed in two subjects. A mean improvement of 57.8% in speech recognition was observed with a mean WRS at 65 dB SPL improving from 14.8% (SD 21.9%) preoperatively to a mean aided score of 72.6% (SD 18.6%). Sound field thresholds improved from an average 4PTA SF of 64.1 dB HL (SD 9.8 dB HL) to 37.0 dB HL (SD 8.9 dB HL), resulting in a mean functional gain of 27.1 dB. There was no significant difference in WRS or functional gain between the coupler types. Conclusion Initial experience shows that all three third generation vibroplasty couplers represent safe and efficient attachment options for the FMT allowing the surgeon to choose the coupling type based on the present pathology.

The Hannover Coupler V2: Audiological outcomes of a round window coupler for the Vibrant Soundbridge

“…With a maximum increase between IA and 3M appointment, results were stable at the 6M appointment, when subjects achieved an aided median WRS in quiet of 80% (75.0% ± 17.8%). This exceeded the results of patients with RW coupling in other publications, for example in Zahnert et al 35 (73.3% ± 26.0%, n = 9, RW Titan Coupler), Sprinzl et al 36 (51.8% ± 26.6%, n = 31, without coupler) and Rahne et al 12 (62.9% ± 24%, n = 9, RW soft coupler). Even with a BC threshold exceeding the indication limit, good audiological results were achieved (ID01 90% WRS, ID06 70% WRS).…”

“…Regarding the RW coupling, clinical outcomes suffered from large variations 10–12 . Main reasons are the mismatch of the diameter of the FMT and the RW membrane 13 and the surgically challenging placement of the FMT at the RW 14 .…”

“…[5][6][7][8][9] Regarding the RW coupling, clinical outcomes suffered from large variations. [10][11][12] Main reasons are the mismatch of the diameter of the FMT and the RW membrane 13 and the surgically challenging placement of the FMT at the RW. 14 The RW niche must be enlarged to fit the FMT, especially the bone close to the RW membrane, to improve the contact between RW membrane and FMT.…”

Ergebnisse und Lebensqualität nach Implantation aktiver Mittelohrimplantate

“…Um eine Standardisierung der Andruckkraft zu erreichen, fokussiert die Forschung auch auf die Entwicklung eines spezifischen Kuppelelements mit einer mechanischen Feder zur rückwärtigen Abstützung und damit kontrollierbarer Vorlast [158,159]. Der effektive Hörgewinn bei Nutzung eines solchen Koppelelementes liegt zwischen 0,6 und −25 dB [160][161][162], und damit insbesondere im Frequenzbereich > 500 Hz über den mit den bisherigen Couplern erzielten Werten [141,147]. Das erreichte Einsilberverstehen bei 65 dB SPL in Ruhe lag in diesen kleinen Fallserien mit 79-83 % im Bereich der mit den etablierten Couplern erzielten Ergebnisse (63-80 %), wobei in allen Untersuchungen eine sehr große Streubreite zu verzeichnen war [125,145,160,161,163].…”

“…Insbesondere bei Kindern mit Gehörgangsatresie und intakter Gehörknöchelchenkette stellt der kurze Ambossfortsatz oft einen sehr gut zugänglichen Ankopplungsort dar, ohne den oft atypisch verlaufenden Nervus facialis zu gefährden. [141,142]. Das chirurgisch deutlich vereinfachte Vorgehen spricht jedoch für die Ankopplung des FMT am kurzen Ambossfortsatz.…”