For Professionals Vibrant Soundbridge VibroplastyTM Couplers New Possibilities in Vibroplasty The Vibrant Soundbridge has proven to be an effective Vibroplasty and reliable middle ear implant over many years.The This versatility of the FMT has led to successful surgical system consists of an internal and an external applications, called Vibroplasty. Vibroplasty is the component. treatment of hearing loss via vibratory stimulation in the middle ear. For mild to severe sensorineural hearing The external component, the Amadé audio processor, loss as well as for conductive and mixed hearing losses, offers the latest hearing technology combined with the different treatments have proven to be safe, enhanced features. The internal implant contains the effective and reliable in various complicated middle ear innovative patented technology of the FMT which can conditions. be used in a very flexible way to optimally compensate different kinds of hearing loss. Alongside the existing and very successful ways of placing the FMT, such as the Incus or the Round A feature unique to the Vibrant Soundbridge is the Window Vibroplasty, Vibroplasty Couplers1 now offer single point attachment of the FMT.This means that additional ways of attaching the FMT in the middle ear. the FMT is only attached to the structure of the middle This allows even more surgical flexibility in a variety of ear which it is stimulating. It is not fixed to the mastoid. conditions and anatomies. Vibroplasty Couplers are attached to the FMT and couple the FMT stimulation to various middle ear structures. Vibroplasty Couplers were developed together with Prof. K.-B. Hüttenbrink from Cologne and Kurz GmbH, Germany 1 VibroplastyTM Couplers OVAL WINDOW When there is no stapes super structure, a Vibroplasty-OW-Coupler can be placed directly onto the stapes footplate. Cartilage in OW niche to stabilize assembly. * * HEAD OF THE STAPES Alternative coupling aids for the FMT attachment to the head of the stapes are available in Vibroplasty-CliP-Coupler and Vibroplasty-Bell-Coupler design. Advantages: • Standardized procedure in the oval window region • Uses natural pathway of sound • Available in different sizes ROUND WINDOW When the anatomy does not allow for a perpendicular placement of the FMT to the round window membrane, a Vibroplasty-RW-Coupler can be used as an alternative coupling aid. Advantages: • More flexibility in Round Window Vibroplasty • Adapts to fit smaller round window diameters • Less drilling in many cases Cartilage to give pre-stress. * * Clinical experience & Technical Data First clinical experience is available from Prof. K.-B. Hüttenbrink in Cologne, Germany. Graphs below show audiometric results with Vibroplasty-OW-Coupler and Vibroplasty-CliP-Coupler. 0 dB dB VIBRANT SOUNDBRIDGE pre- /postoperative BC postoperative AC preoperative AC 20 20 30 30 40 40 50 50 60 60 70 70 80 80 90 90 100 100 110 110 120 120 0,5 1 0 10 10 1 2 3 4 kHz Results with Vibroplasty-OW-Coupler* 3 4 2 1 0,5 2 1 2 3 4 kHz 3 A Vibroplasty-CliP-Coupler Results with n=4 n=3 A *Adapted from Prof. K.-B. Hüttenbrink et al., TORP-vibroplasty: a new alternative for the chronically disabled middle ear Otol Neurotol. 2008 4.8 mm B 2.5 mm 4.8 mm B 0.2 mm 2.5 mm 0.2 mm 2.5 mm C Vibroplasty-OW-Coupler* C 1 2.5 m 2 1 2 Vibroplasty-CliP-Coupler* 3 3 4 Vibroplasty-Bell-Coupler* 4 A Vibroplasty-RW-Coupler D A 2. D 4.8 mm3.2 mm (C) VIBRANT MED-EL 2009 All rights reserved for this document which may not be reproduced or disclosed to third parties without the prior written consent of VIBRANT MED-EL Hearing Technology GmbH 1.5 mm Bezeichnung / Description Vibroplasty Coupler Millimeter *other sizes on request Allgemeintoleranz / Tolerance not specified: Werkstoff / Material: Gewicht / Weight [approx., g]: 0.01 Dateiname / Filename: 1002644+FMT Gezeichnet Drawn Datum / Date Name / Name 01.06.2010 B. Mueller A4 28106 2.0 Zeichnungs-Nr. / Drawing - No. Maßstab / Scale n/a EUROP. PROJ. Blatt / Page 1 20:1 / 1 D D 2.5 mm 2.5 mm www.medel.com 0.2 mm 3.2 mm E E C Oberfläche / Surface finish: Maße in / Units in: 0.2 mm 2.5 mm 2.5 mm 0.9 mm E C B E 3.2 mm 0.2 mm 0.2 m 3.2 mm 2.5 mm (C) VIBRANT MED-EL 2009 All rights reserved for this document which may not be reproduced or disclosed to third parties without the prior written consent of VIBRANT MED-EL Hearing Technology GmbH B 2.5 mm 2.5 mm 0.2 mm 4.8 mm 0.2 mm 0.9 mm 1.5 mm Bezeichnung / Description Oberfläche / Surface finish: Maße in / Units in: Vibroplasty C Millimeter Allgemeintoleranz / Tolerance not specified: Gewicht / Weight [approx., g]: Gezeichnet Drawn Werkstoff / Material: 0.01 Dateiname / Filename: 1002644+FMT A4 Datum / Date Name / Name 01.06.2010 B. Mueller EUROP. PROJ. Zeichnungs-Nr. / Drawing - No. n/a