Vibroplasty Coupler - Partially-implantable middle ear implant system

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
13-11-2017

제공처:

MED-EL Implant Systems Australasia Pty Ltd

수업:

Class III

Manufactured by:

Med-El Elektromedizinische Gerate GmbH Furstenweg 77a, Innsbruck, 6020 Austria

치료 영역:

30084 - Partially-implantable middle ear implant system

치료 징후:

The couplers are made of varying grades of titanium and provide placement options for the floating mass transducer (FMT) to functional middle ear vibratory structures ? incus; stapes; round window. The different types of couplers account for the anatomic condition variability in compromised ears and provide more options for fixation and adaptation to middle ear characteristics when anatomy does not allow for perpendicular placement. The Vibroplasty Couplers are intended to be used in combination with the Vibrant Soundbridge to facilitate the coupling between the FMT and a Vibratory Structure of the middle ear. The prosthesis type is chosen on the basis of the ossicular remnants once all primary disease has been removed from the middle ear.

승인 상태:

A

승인 날짜:

2011-06-17

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