Long‐Term Stability and Safety of the Soundbridge Coupled to the Round Window

• Published in: The Laryngoscope Vol. 131; no. 5; pp. E1434 - E1442
• Main Authors: Sprinzl, Georg Mathias, Schoerg, Philipp, Muck, Stefanie, Jesenko, Max, Speiser, Sophie, Ploder, Marlene, Edlinger, Stefan Herwig, Magele, Astrid
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.05.2021
• Subjects: active middle ear implant; Adult; Aged; Aged, 80 and over; AMEI; Austria - epidemiology; Cholesteatoma, Middle Ear - complications; Cholesteatoma, Middle Ear - surgery; Device Removal - statistics & numerical data; Female; Follow-Up Studies; follow‐up; Hearing Loss, Conductive - diagnosis; Hearing Loss, Conductive - etiology; Hearing Loss, Conductive - surgery; Hearing Loss, Mixed Conductive-Sensorineural - diagnosis; Hearing Loss, Mixed Conductive-Sensorineural - etiology; Hearing Loss, Mixed Conductive-Sensorineural - surgery; Humans; implantation; long‐term; Male; Middle Aged; Ossicular Prosthesis - adverse effects; Ossicular Replacement - adverse effects; Ossicular Replacement - instrumentation; Ossicular Replacement - methods; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Retrospective Studies; Round window; Round Window, Ear - surgery; Treatment Outcome; vibrant soundbridge; VSB; Young Adult; Austria; vibrant soundbridge; follow-up; implantation; Round window; performance; VSB; active middle ear implant; AMEI; long-term
• ISSN: 0023-852X; 1531-4995
• DOI: 10.1002/lary.29269

Objective The objective of the study was to demonstrate the long‐term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). Methods This retrospective study evaluated the short‐ and long‐term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short‐term examination group followed up for less than 12 months (<12 months) and a long‐term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. Results 46 patients with an average long‐term follow‐up period of 31.43 months (13–75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long‐term follow up. Conclusion The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long‐term follow‐up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. Level of Evidence 4 (Case‐series) Laryngoscope, 131:E1434–E1442, 2021