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 twenty-five 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 PTA4 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 4PTASF 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.

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers / Rahne, Torsten; Henryk Skarzynski, Piotr; Hagen, Rudolf; Radeloff, Andreas; Lassaletta, Luis; Barbara, Maurizio; Plontke, Stefan K.; Mlynski, Robert. - In: EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY. - ISSN 0937-4477. - May 25(2020), pp. 1-9. [10.1007/s00405-020-06064-x]

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

Maurizio Barbara
Membro del Collaboration Group
;
2020

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 twenty-five 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 PTA4 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 4PTASF 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.
2020
Vibroplasty, Couplers, active middle ear implant, Vibrant Soundbridge, hearing loss
01 Pubblicazione su rivista::01a Articolo in rivista
A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers / Rahne, Torsten; Henryk Skarzynski, Piotr; Hagen, Rudolf; Radeloff, Andreas; Lassaletta, Luis; Barbara, Maurizio; Plontke, Stefan K.; Mlynski, Robert. - In: EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY. - ISSN 0937-4477. - May 25(2020), pp. 1-9. [10.1007/s00405-020-06064-x]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1405808
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