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

Georg Mathias Sprinzl; Philipp Schoerg; Stefanie Muck; Max Jesenko; Sophie Speiser; Marlene Ploder; Stefan Herwig Edlinger; Astrid Magele

doi:10.1002/lary.29269

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

Georg Mathias Sprinzl, Philipp Schoerg, Stefanie Muck, Max Jesenko, Sophie Speiser, Marlene Ploder, Stefan Herwig Edlinger, Astrid Magele

Division of Otorhinolaryngology (University Hospital St. Pölten)

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

12 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 language	English
Pages (from-to)	E1434-E1442
Journal	Laryngoscope
Volume	131
Issue number	5
DOIs	https://doi.org/10.1002/lary.29269
Publication status	Published - 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

Access to Document

10.1002/lary.29269

Cite this

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title = "Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window",

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. P{\"o}lten 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.",

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",

author = "Sprinzl, {Georg Mathias} and Philipp Schoerg and Stefanie Muck and Max Jesenko and Sophie Speiser and Marlene Ploder and Edlinger, {Stefan Herwig} and Astrid Magele",

note = "Publisher Copyright: {\textcopyright} 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).",

year = "2021",

month = may,

doi = "10.1002/lary.29269",

language = "English",

volume = "131",

pages = "E1434--E1442",

journal = "Laryngoscope",

issn = "0023-852X",

publisher = "Wiley-Blackwell",

number = "5",

}

TY - JOUR

T1 - Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window

AU - Sprinzl, Georg Mathias

AU - Schoerg, Philipp

AU - Muck, Stefanie

AU - Jesenko, Max

AU - Speiser, Sophie

AU - Ploder, Marlene

AU - Edlinger, Stefan Herwig

AU - Magele, Astrid

N1 - Publisher 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).

PY - 2021/5

Y1 - 2021/5

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Austria/epidemiology

KW - Cholesteatoma, Middle Ear/complications

KW - Device Removal/statistics & numerical data

KW - Female

KW - Follow-Up Studies

KW - Hearing Loss, Conductive/diagnosis

KW - Hearing Loss, Mixed Conductive-Sensorineural/diagnosis

KW - Humans

KW - Male

KW - Middle Aged

KW - Ossicular Prosthesis/adverse effects

KW - Ossicular Replacement/adverse effects

KW - Postoperative Complications/epidemiology

KW - Retrospective Studies

KW - Round Window, Ear/surgery

KW - Treatment Outcome

KW - Young Adult

KW - active middle ear implant

KW - AMEI

KW - follow-up

KW - vibrant soundbridge

KW - VSB

KW - implantation

KW - performance

KW - Round window

KW - long-term

UR - http://www.scopus.com/inward/record.url?scp=85096678887&partnerID=8YFLogxK

U2 - 10.1002/lary.29269

DO - 10.1002/lary.29269

M3 - Journal article

C2 - 33210744

SN - 0023-852X

VL - 131

SP - E1434-E1442

JO - Laryngoscope

JF - Laryngoscope

IS - 5

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

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