The active middle ear implant Vibrant Soundbridge© provides a variety of coupling modalities of the floating mass transducer (FMT) to various structures of the ossicular chain and the round window. A retrospective analysis was performed on 125 subjects (n = 137 ears) (1) to compare the efficacy of the different FMT coupling modalities with increasing degree of hearing loss, (2) to compare the performance in speech outcome and the effective gain between the coupling types, and (3) to evaluate the risk of additional hearing loss of each coupling procedure. The patients were grouped according to their type of FMT coupling into incus vibroplasty (incus group, n = 59), round window vibroplasty with coupler (RWC group, n = 23), round window vibroplasty without coupler (RW group, n = 22), and oval window vibroplasty with coupler (OWC group, n = 33). For each coupling group, pre- and postoperative thresholds, the results of the Freiburg monosyllable test at 65 dB SPL, and the effective gain across frequencies (0.5-6 kHz) were evaluated. A logistic regression function was used to describe the relationship between word recognition scores (WRS, in % correct) and the mean bone conduction (BC) hearing loss. The surgical procedure had no clinically relevant effect on BC thresholds of patients in each coupling group. The BC pure tone average (PTA4) for 50% WRS predicted by the model function was similar for the incus (48.2 dB nHL), RW (47.8 dB nHL), and OWC (49.0 dB nHL) groups, but higher for the RWC group (67.9 dB nHL). However, the median WRS was 80% or better with no significant differences in speech perception between coupling types (Kruskal-Wallis test, p = 0.229). The effective gain shows an advantage for the incus coupling between 0.5 and 2 kHz over the other coupling types. The performance of the FMT coupling modalities is equally good for patients with a mild-to-moderate hearing loss, but the efficacy of coupling types differs for patients with greater hearing loss (>48 dB BC HL).

Keywords:
Middle ear implant, Oval window, Round window, Vibroplasty, Coupling types, Vibrant Soundbridge©, Indication range
1.
Atturo F, Barbara M, Rask-Andersen H: Is the human round window really round? An anatomic study with surgical implications. Otol Neurotol 2014;35:1354-1360.
2.
Baumgartner W-D, Böheim K, Hagen R, Müller J, Lenarz T, Reiss S, et al: The Vibrant Soundbridge for conductive and mixed hearing losses: European multicenter study results. Adv Otorhinolaryngol 2010;69:38-50.
3.
Beleites T, Neudert M, Beutner D, Hüttenbrink K-B, Zahnert T: Experience with vibroplasty couplers at the stapes head and footplate. Otol Neurotol 2011;32:1468-1472.
4.
Clark JG: Uses and abuses of hearing loss classification. ASHA 1981;23:493-500.
5.
Colletti V, Soli SD, Carner M, Colletti L: Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol 2006;45:600-608.
6.
Dumon T: Vibrant Soundbridge middle ear implant in otosclerosis; in Arnold W, Häusler R (eds): Advances in Oto-Rhino-Laryngology. Basel, Karger, 2007, pp 320-322.
7.
Fisch U, Cremers WRJ, Lenarz T, Weber B, Babighian G, Uziel AS, et al: Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol 2001;22:962-972.
8.
Fraysse B, Lavieille J-P, Schmerber S, Enée V, Truy E, Vincent C, et al: A multicenter study of the Vibrant Soundbridge middle ear implant: early clinical results and experience. Otol Neurotol 2001;22:952-961.
9.
Hüttenbrink KB, Beutner D, Zahnert T: Clinical results with an active middle ear implant in the oval window; in Böheim K (ed): Advances in Oto-Rhino-Laryngology. Basel, Karger, 2010, pp 27-31.
10.
Kontorinis G, Lenarz T, Mojallal H, Hinze A-L, Schwab B: Power stapes: an alternative method for treating hearing loss in osteogenesis imperfecta? Otol Neurotol 2011;32:589-595.
11.
Lenarz T, Weber PB, Mack KF, Battmer R-D, Gnadeberg D: Vibrant Soundbridge implant: a new hearing prosthesis for patients with sensorineural hearing loss. Part 1. Principle of the Soundbridge system and initial clinical results. Laryngol Rhinol Otol (Stuttg) 1998;77:247-255.
12.
Maier H, Hinze A-L, Gerdes T, Busch S, Salcher R, Schwab B, et al: Long-term results of incus vibroplasty in patients with moderate-to-severe sensorineural hearing loss. Audiol Neurotol 2015;20:136-146.
13.
Mlynski R, Dalhoff E, Heyd A, Wildenstein D, Hagen R, Gummer AW, et al: Reinforced active middle ear implant fixation in incus vibroplasty. Ear Hear 2015a;36:72-81.
14.
Mlynski R, Dalhoff E, Heyd A, Wildenstein D, Rak K, Radeloff A, et al: Standardized active middle-ear implant coupling to the short incus process. Otol Neurotol 2015b;36:1390-1398.
15.
Mosnier I, Sterkers O, Bouccara D, Labassi S, Bebear J-P, Bordure P, et al: Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years. Ear Hear 2008;29:281-284.
16.
Pau HW, Just T: Third window vibroplasty: an alternative in surgical treatment of tympanosclerotic obliteration of the oval and round window niche. Otol Neurotol 2010;31:225-227.
17.
Pennings RJE, Ho A, Brown J, van Wijhe RG, Bance M: Analysis of Vibrant Soundbridge placement against the round window membrane in a human cadaveric temporal bone model. Otol Neurotol 2010;31:998-1003.
18.
Santek M (inventor): Optimal pre-load for floating mass transducers. US Patent (US 9,191,760 B2), November 17, 2015. Innsbruck, VIBRANT MED-EL, 2015.
19.
Schraven SP, Dalhoff E, Wildenstein D, Hagen R, Gummer AW, Mlynski R: Alternative fixation of an active middle ear implant at the short incus process. Audiol Neurotol 2014;19:1-11.
20.
Schraven SP, Grossmann W, Rak K, Hagen R, Shehata-Dieler W, Hagen R, Mlynski R: Long-term stability of the active middle-ear implant with floating-mass transducer technology: a single-center study. Otol Neurotol 2016;37:252-266.
21.
Schwab B, Grigoleit S, Teschner M: Do we really need a coupler for the round window application of an AMEI? Otol Neurotol 2013;34:1181-1185.
22.
Schwab B, Salcher RB, Maier H, Kontorinis G: Oval window membrane vibroplasty for direct acoustic cochlear stimulation: treating severe mixed hearing loss in challenging middle ears. Otol Neurotol 2012;33:804-809.
23.
Schwab B, Salcher RB, Teschner M: Comparison of two different titanium couplers for an active middle ear implant. Otol Neurotol 2014;35:1615-1620.
24.
Snik AFM, Cremers C: Vibrant semi-implantable hearing device with digital sound processing - effective gain and speech perception. Arch Otolaryngol Head Neck Surg 2001;127:1433-1437.
25.
Sterkers O, Boucarra D, Labassi S, Bebear J-P, Dubreuil C, Frachet B, et al: A middle ear implant, the Symphonix Vibrant Soundbridge: retrospective study of the first 125 patients implanted in France. Otol Neurotol 2003;24:427-436.
26.
van Rooij JC, Plomp R: Auditive and cognitive factors in speech perception by elderly listeners. II. Multivariate analyses. J Acoust Soc Am 1990;88:2611-2624.
27.
Vaughan NE, Letowski T: Effects of age, speech rate, and type of test on temporal auditory processing. J Speech Lang Hear Res 1997;40:1192.
28.
Venail F, Lavieille JP, Meller R, Deveze A, Tardivet L, Magnan J: New perspectives for middle ear implants: first results in otosclerosis with mixed hearing loss. Laryngoscope 2007;117:552-555.
29.
Wagner F, Todt I, Wagner J, Ernst A: Indications and candidacy for active middle ear implants. Adv Otorhinolaryngol 2010;69:20-26.
30.
Yang S-M, Zou Y-H, Li J-N, Jiao Q-S, Yi H-J, Han D-Y: Vibrant Soundbridge implantation via the third window in two Chinese patients with severe bilateral congenital aural atresia. Acta Otolaryngol 2014;134:1-6.
31.
Zehlicke T, Dahl R, Just T, Pau H-W: Vibroplasty involving direct coupling of the floating mass transducer to the oval window niche. J Laryngol Otol 2010;124:716-719.
32.
Zwartenkot JW, Snik AFM, Mylanus EAM, Mulder JJS: Amplification options for patients with mixed hearing loss. Otol Neurotol 2014;35:221-226.
© 2017 S. Karger AG, Basel
2017
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.