Vibrant Soundbridge VibroplastyTM Couplers - Med-El
Vibrant Soundbridge VibroplastyTM Couplers - Med-El
Vibrant Soundbridge VibroplastyTM Couplers - Med-El
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For Professionals<br />
<strong>Vibrant</strong> <strong>Soundbridge</strong><br />
Vibroplasty TM <strong>Couplers</strong>
New Possibilities in Vibroplasty<br />
The <strong>Vibrant</strong> <strong>Soundbridge</strong> has proven to be an effective<br />
and reliable middle ear implant over many years.The<br />
system consists of an internal and an external<br />
component.<br />
The external component, the Amadé audio processor,<br />
offers the latest hearing technology combined with<br />
enhanced features. The internal implant contains the<br />
innovative patented technology of the FMT which can<br />
be used in a very flexible way to optimally compensate<br />
different kinds of hearing loss.<br />
A feature unique to the <strong>Vibrant</strong> <strong>Soundbridge</strong> is the<br />
single point attachment of the FMT.This means that<br />
the FMT is only attached to the structure of the middle<br />
ear which it is stimulating. It is not fixed to the mastoid.<br />
Vibroplasty<br />
This versatility of the FMT has led to successful surgical<br />
applications, called Vibroplasty. Vibroplasty is the<br />
treatment of hearing loss via vibratory stimulation in<br />
the middle ear. For mild to severe sensorineural hearing<br />
loss as well as for conductive and mixed hearing losses,<br />
the different treatments have proven to be safe,<br />
effective and reliable in various complicated middle ear<br />
conditions.<br />
Alongside the existing and very successful ways of<br />
placing the FMT, such as the Incus or the Round<br />
Window Vibroplasty, Vibroplasty <strong>Couplers</strong>1 now offer<br />
additional ways of attaching the FMT in the middle ear.<br />
This allows even more surgical flexibility in a variety of<br />
conditions and anatomies. Vibroplasty <strong>Couplers</strong> are<br />
attached to the FMT and couple the FMT stimulation to<br />
various middle ear structures.<br />
1 Vibroplasty <strong>Couplers</strong> were developed together with Prof. K.-B. Hüttenbrink from Cologne and Kurz GmbH, Germany
Vibroplasty TM <strong>Couplers</strong><br />
OVAL WINDOW<br />
When there is no stapes super structure, a<br />
Vibroplasty-OW-Coupler can be placed directly<br />
onto the stapes footplate.<br />
* Cartilage in OW niche to stabilize assembly.<br />
HEAD OF THE STAPES<br />
Alternative coupling aids for the FMT<br />
attachment to the head of the stapes are<br />
available in Vibroplasty-CliP-Coupler and<br />
Vibroplasty-Bell-Coupler design.<br />
Advantages:<br />
• Standardized procedure in the oval<br />
window region<br />
• Uses natural pathway of sound<br />
• Available in different sizes<br />
ROUND WINDOW<br />
When the anatomy does not allow for a perpendicular<br />
placement of the FMT to the round window membrane,<br />
a Vibroplasty-RW-Coupler can be used as an<br />
alternative coupling aid.<br />
Advantages:<br />
• More flexibility in Round Window Vibroplasty<br />
• Adapts to fit smaller round window diameters<br />
• Less drilling in many cases<br />
* Cartilage to give pre-stress.<br />
*<br />
*
28106 2.0<br />
Clinical experience & Technical Data<br />
First clinical experience is available from Prof. K.-B. Hüttenbrink in Cologne, Germany. Graphs below show<br />
audiometric results with Vibroplasty-OW-Coupler and Vibroplasty-CliP-Coupler.<br />
A<br />
B<br />
C<br />
D<br />
VIBRANT SOUNDBRIDGE<br />
pre- /postoperative BC<br />
postoperative AC<br />
preoperative AC<br />
1<br />
www.medel.com<br />
E<br />
B<br />
C<br />
D<br />
1<br />
1.5 mm<br />
2.5 mm<br />
dB 0<br />
dB 0<br />
10<br />
10<br />
20<br />
20<br />
30<br />
30<br />
40<br />
40<br />
50<br />
50<br />
60<br />
60<br />
70<br />
70<br />
80<br />
80<br />
90<br />
90<br />
100<br />
100<br />
110<br />
110<br />
120<br />
120<br />
1<br />
2<br />
0,5 1 2 3 4 kHz 0,5 1 2 3 4 kHz<br />
4.8 mm3.2<br />
mm<br />
2.5 mm 0.9 mm<br />
2<br />
4.8 mm<br />
Maße in / Units in: Millimeter<br />
Allgemeintoleranz / Tolerance not specified: Datum / Date Name / Name<br />
-<br />
Gezeichnet<br />
Werkstoff / Material: Zeichnungs-Nr. / Drawing - No.<br />
Drawn 01.<br />
06.<br />
2010 B. Mueller<br />
Gewicht / Weight [approx., g]: 0.01<br />
Dateiname / Filename: 1002644+FMT<br />
A4<br />
EUROP.<br />
PROJ.<br />
D<br />
2<br />
3.2 mm<br />
Results with Vibroplasty-OW-Coupler* n=4<br />
3<br />
3<br />
0.2 mm<br />
2.5 mm<br />
4<br />
2.5 mm<br />
2.5 mm<br />
0.2 mm 4.8 mm<br />
0.2 mm<br />
2.5 mm<br />
2.5 mm<br />
0.2 mm<br />
4<br />
Results with A Vibroplasty-CliP-Coupler n=3<br />
A<br />
*Adapted from Prof. K.-B. Hüttenbrink et al., TORP-vibroplasty: a new alternative for the chronically disabled middle ear Otol Neurotol. 2008<br />
1<br />
2<br />
Vibroplasty-OW-Coupler* Vibroplasty-CliP-Coupler*<br />
E<br />
(C) VIBRANT MED-EL 2009<br />
All rights reserved for this document which may not be reproduced<br />
or disclosed to third parties without the prior written<br />
consent of VIBRANT MED-EL Hearing Technology GmbH<br />
Oberfläche / Surface finish:<br />
*other sizes on request<br />
A<br />
B<br />
C<br />
E<br />
Bezeichnung / Description<br />
Vibroplasty Coupler<br />
n/a<br />
Maßstab / Scale 20:1<br />
Blatt / Page 1 / 1<br />
3.2 mm<br />
3<br />
4<br />
Vibroplasty-Bell-Coupler* Vibroplasty-RW-Coupler<br />
0.2 mm<br />
2.5 mm<br />
2.5 mm<br />
0.2 mm<br />
B<br />
C<br />
D<br />
E<br />
(C) VIBRANT MED-EL 2009<br />
All rights reserved for this document which may not be reproduced<br />
or disclosed to third parties without the prior written<br />
consent of VIBRANT MED-EL Hearing Technology GmbH<br />
Oberfläche / Surface finish:<br />
1.5 mm<br />
2.5 mm<br />
4.8 mm<br />
0.9 mm<br />
3.2 mm<br />
Maße in / Units in: Millimeter<br />
Allgemeintoleranz / Tolerance not specified: -<br />
Datum / Date Name / Name<br />
Werkstoff / Material:<br />
Gezeichnet<br />
Drawn 01.<br />
06.<br />
2010 B. Mueller Zeichnungs-Nr. / Drawing - No.<br />
Gewicht / Weight [approx., g]: 0.01<br />
Dateiname / Filename: 1002644+FMT<br />
A4<br />
EUROP.<br />
PROJ.<br />
3<br />
Bezeichnung / Description<br />
2.5 m<br />
0.2 mm<br />
n/a<br />
2.<br />
0.2 m<br />
Vibroplasty C