Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.
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
AMEI
Round window
VSB
active middle ear implant
follow-up
implantation
long-term
performance
vibrant soundbridge
Journal
The Laryngoscope
ISSN: 1531-4995
Titre abrégé: Laryngoscope
Pays: United States
ID NLM: 8607378
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
revised:
30
10
2020
received:
01
09
2020
accepted:
03
11
2020
pubmed:
20
11
2020
medline:
11
5
2021
entrez:
19
11
2020
Statut:
ppublish
Résumé
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). 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. 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. 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. 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.
Identifiants
pubmed: 33210744
doi: 10.1002/lary.29269
pmc: PMC8246711
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
E1434-E1442Informations de copyright
© 2020 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).
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