The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
8
Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty.
Medical University of Vienna
Vienna, Austria
Change in voice quality by RBH-Scale
Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance).
Time frame: pre-surgery, right after temporarily implantation
Change in Glottal closure by Södersten and Lindestad classification
Time frame: pre-surgery, right after temporarily implantation
Change in maximum phonation time in seconds
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
Time frame: pre-surgery, right after temporarily implantation
Evaluation of surgical handling and device fitting using a VAS scale
Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied)
Time frame: right after temporarily implantation
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