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

Research output: Journal article (peer-reviewed)Journal article

6 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)E1434-E1442
JournalLaryngoscope
Volume131
Issue number5
DOIs
Publication statusPublished - May 2021

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Austria/epidemiology
  • Cholesteatoma, Middle Ear/complications
  • Device Removal/statistics & numerical data
  • Female
  • Follow-Up Studies
  • Hearing Loss, Conductive/diagnosis
  • Hearing Loss, Mixed Conductive-Sensorineural/diagnosis
  • Humans
  • Male
  • Middle Aged
  • Ossicular Prosthesis/adverse effects
  • Ossicular Replacement/adverse effects
  • Postoperative Complications/epidemiology
  • Retrospective Studies
  • Round Window, Ear/surgery
  • Treatment Outcome
  • Young Adult
  • active middle ear implant
  • AMEI
  • follow-up
  • vibrant soundbridge
  • VSB
  • implantation
  • performance
  • Round window
  • long-term

ASJC Scopus subject areas

  • Otorhinolaryngology

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