A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers.
Adolescent
Adult
Aged
Child
Cohort Studies
Ear, Middle
Family Characteristics
Female
Hearing Aids
Hearing Loss, Mixed Conductive-Sensorineural
/ rehabilitation
Humans
Male
Middle Aged
Ossicular Prosthesis
Ossicular Replacement
/ methods
Quality of Life
Retrospective Studies
Round Window, Ear
/ physiology
Treatment Outcome
Young Adult
Active middle ear implant
Couplers
Hearing loss
Vibrant Soundbridge
Vibroplasty
Journal
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
ISSN: 1434-4726
Titre abrégé: Eur Arch Otorhinolaryngol
Pays: Germany
ID NLM: 9002937
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
18
09
2019
accepted:
15
05
2020
pubmed:
27
5
2020
medline:
24
2
2021
entrez:
27
5
2020
Statut:
ppublish
Résumé
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. Retrospective multicenter cohort study of 25 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). Bone conduction threshold changes of more than 10 dB in 4PTA 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.
Identifiants
pubmed: 32451668
doi: 10.1007/s00405-020-06064-x
pii: 10.1007/s00405-020-06064-x
pmc: PMC7814408
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
67-75Références
Luetje CM, Brackman D, Balkany TJ et al (2002) Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study. Otolaryngol Head Neck Surg 126:97–107
doi: 10.1067/mhn.2002.122182
Huber AM, Ball GR, Veraguth D et al (2006) A new implantable middle ear hearing device for mixed hearing loss: a feasibility study in human temporal bones. Otol Neurotol 27:1104–1109
doi: 10.1097/01.mao.0000244352.49824.e6
Hüttenbrink K-B, Zahnert T, Bornitz M et al (2008) TORP-vibroplasty: a new alternative for the chronically disabled middle ear. Otol Neurotol 29:965–971
doi: 10.1097/MAO.0b013e318185fad8
Fisch U, Cremers CW, Lenarz T et al (2001) Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol 22:962–972
doi: 10.1097/00129492-200111000-00042
Lenarz T, Weber BP, Mack KF et al (1998) The Vibrant Soundbridge system: a new kind of hearing aid for sensorineural hearing loss. 1: Function and initial clinical experiences. Laryngo Rhino Otol 77:247–255
doi: 10.1055/s-2007-996970
Luers JC, Huttenbrink KB, Zahnert T et al (2013) Vibroplasty for mixed and conductive hearing loss. Otol Neurotol 34:1005–1012
doi: 10.1097/MAO.0b013e3182990d2b
Schraven SP, Gromann W, Rak K et al (2016) Long-term stability of the active middle-ear implant with floating-mass transducer technology: a single-center study. Otol Neurotol 37:252–266
doi: 10.1097/MAO.0000000000000943
Zahnert T, Mlynski R, Lowenheim H et al (2019) Long-term outcomes of vibroplasty coupler implantations to treat mixed/conductive hearing loss. Audiol Neurootol 23:316–325
doi: 10.1159/000495560
Chen T, Ren LJ, Yin DM et al (2017) A comparative study of MED-EL FMT attachment to the long process of the incus in intact middle ears and its attachment to disarticulated stapes head. Hear Res 353:97–103
doi: 10.1016/j.heares.2017.06.006
Schraven SP, Mlynski R, Dalhoff E et al (2016) Coupling of an active middle-ear implant to the long process of the incus using an elastic clip attachment. Hear Res 340:179–184
doi: 10.1016/j.heares.2016.03.012
Mlynski R, Dalhoff E, Heyd A et al (2015) Standardized active middle-ear implant coupling to the short incus process. Otol Neurotol 36:1390–1398
doi: 10.1097/MAO.0000000000000822
Schraven SP, Rak K, Cebulla M et al (2018) Surgical impact of coupling an active middle ear implant to short incus process. Otol Neurotol 39:688–692
doi: 10.1097/MAO.0000000000001830
Colletti V, Soli SD, Carner M et al (2006) Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol 45:600–608
doi: 10.1080/14992020600840903
Skarzynski H, Olszewski L, Skarzynski PH et al (2014) Direct round window stimulation with the Med-El Vibrant Soundbridge: 5 years of experience using a technique without interposed fascia. Eur Arch Otorhinolaryngol 271:477–482
doi: 10.1007/s00405-013-2432-1
Olszewski L, Jedrzejczak WW, Piotrowska A et al (2017) Round window stimulation with the Vibrant Soundbridge: comparison of direct and indirect coupling. Laryngoscope 127:2843–2849
doi: 10.1002/lary.26536
Schwab B, Grigoleit S, Teschner M (2013) Do we really need a coupler for the round window application of an AMEI? Otol Neurotol 34:1181–1185
doi: 10.1097/MAO.0b013e31829b57c2
Zahnert T, Lowenheim H, Beutner D et al (2016) Multicenter clinical trial of vibroplasty couplers to treat mixed/conductive hearing loss: first results. Audiol Neurootol 21:212–222
doi: 10.1159/000444616
Schraven SP, Dalhoff E, Wildenstein D et al (2014) Alternative fixation of an active middle ear implant at the short incus process. Audiol Neurootol 19:1–11
doi: 10.1159/000354981
Celerier C, Thierry B, Coudert C et al (2017) Results of VSB implantation at the short process of the incus in children with ear atresia. Int J Pediatr Otorhinolaryngol 93:83–87
doi: 10.1016/j.ijporl.2016.12.038
Thomas JP, Voelter C, Neumann K et al (2017) Vibroplasty in severe congenital or acquired meatal stenosis by coupling an active middle ear implant to the short process of the incus. Otol Neurotol 38:996–1004
doi: 10.1097/MAO.0000000000001459
Lee JM, Lee YH, Jung J et al (2017) Audiologic gain of incus short process vibroplasty with conventional incus long process vibroplasty: a retrospective analysis of 36 patients. Otol Neurotol 38:1063–1070
doi: 10.1097/MAO.0000000000001496
Skarzynski PH, Osinska K, Krol B et al (2018) Use of the Vibrant Soundbridge middle ear implant with short process Incus Coupler for chronic obstructive inflammation of the external ear canal: case study. J Hear Sci 8:25–31
Muller A, Mir-Salim P, Zellhuber N et al (2017) Influence of floating-mass transducer coupling efficiency for active middle-ear implants on speech recognition. Otol Neurotol 38:809–814
doi: 10.1097/MAO.0000000000001412
ANSI (2004) Methods for manual pure-tone threshold audiometry. American National Standard, ANSI S3.21-2004
Maier H, Baumann U, Baumgartner WD et al (2018) Minimal reporting standards for active middle ear hearing implants. Audiol Neurootol 23:105–115
doi: 10.1159/000490878
Busch S, Lenarz T, Maier H (2016) Comparison of alternative coupling methods of the Vibrant Soundbridge floating mass transducer. Audiol Neurootol 21:347–355
doi: 10.1159/000453354
Rajan GP, Lampacher P, Ambett R et al (2011) Impact of floating mass transducer coupling and positioning in round window vibroplasty. Otol Neurotol 32:271–277
doi: 10.1097/MAO.0b013e318206fda1
Maier H, Hinze AL, Gerdes T et al (2015) Long-term results of incus vibroplasty in patients with moderate-to-severe sensorineural hearing loss. Audiol Neurootol 20:136–146
doi: 10.1159/000368387
Park YA, Kong TH, Chang JS et al (2017) Importance of adhesiolysis in revision surgery for Vibrant Soundbridge device failures at the short incus process. Eur Arch Otorhinolaryngol 274:3867–3873
doi: 10.1007/s00405-017-4715-4