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Objectives: Medialization thyroplasty (MT) using various implants has been employed as a corrective procedure for unilateral vocal fold paralysis (UVFP). A newly developed APrevent® vocal implant system (VOIS) offers an innovative solution with a finely adjustable design. This study aimed to investigate the long-term functional voice outcomes and benefits of postoperative adjustments in patients receiving MT using the VOIS-implant. Methods: This is a prospective case series study at single tertiary medical center. Fourteen adult patients diagnosed with UVFP received MT with the VOIS implant and were followed up for more than 1 year. Implant adjustment procedure by injecting 0.9% physiological saline solution was performed both during and after the surgery to optimize glottal closure and voice quality. Objective voice outcomes and acoustic parameters were assessed preoperatively and postoperatively at various timepoints. Results: Thirteen patients (93%) received intraoperative balloon adjustment, ranging from 0.05to 0.12 ml. Four patients underwent adjustments postoperatively and exhibited a positive trend towards immediately improving acoustic voice quality. Our long-term results demonstrated a notable improvement after the surgery in voice quality, with significant decreases in VHI-30 and improvements in perceptual parameters of GRBAS scale, acoustic measures such as jitter and signal-to-noise ratio (p < 0.001) and cepstral peak prominence smoothed in sustained vowel and short sentences. The voice outcomes remained stable more than 1 year follow-up. Conclusions: Overall, MT with VOIS implantation provides a favorable long-term outcomes and stability in voice quality for patients with UVFP and also an effective tool for postoperative adjustment without major revision surgeries. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the concept and efficacy of an adjustable implant (Prototype SH30: porcine implant and APrevent® VOIS: human concept) for treatment of unilateral vocal fold paralysis (UVFP) via in vivo mini‐pig studies, human computed tomographic (CT) and magnetic resonance (MR) image analysis, ex‐vivo aerodynamic and acoustic analysis. Methods: Feasibility testing and prototype implantation were performed using in‐vivo UVFP porcine model (n = 8), followed by a dimensional finding study using CT and MR scans of larynges (n = 75) for modification of the implant prototypes. Acoustic and aerodynamic measurements were recorded on excised canine (n = 7) larynges with simulated UVFP before and after medialization with VOIS‐Implant. Results: The prototype showed in the in‐vivo UVFP porcine model an improved glottic closure from grade 6 incomplete closure to complete closure (n = 5), to grade 2 incomplete closure (n = 2) and grade 3 incomplete closure (n = 1). On human CT/MR scans the identification of the correct size was successful in 97.3% using the thyroid cartilage alar "distance S" as the only parameter, which is an important step towards procedure standardization and implant design. Results were confirmed with implantation in human laryngeal cadavers (n = 44). Measurements of the acoustic and aerodynamic effects after implantation showed a significant decreased phonation threshold pressure (p =.0187), phonation threshold flow (p =.0001) and phonation threshold power (p =.0046) on excised canine larynges with simulated UVFP. Percent jitter and percent shimmer decreased (p =.2976; p =.1771) but not significant. Conclusions: Based on the preclinical results four sizes, differing in medial length, implant width and expansion direction of silicone cushions, seem to be enough to satisfy laryngeal size variations. This concept is significantly effective in medializing UVFP and improving the aerodynamic and acoustic qualities of phonation as reported in a preliminary clinical outcome study with long‐term implantation. Level of Evidence: N/A [ABSTRACT FROM AUTHOR]

The online version of the original article can be found at https://doi.org/10.1007/s00405-023-08367-1Correction: European Archives of Oto-Rhino-Laryngology (2023) 281:1371–1378https://doi.org/10.1007/s00405-023-08367-1In this article the ' IRB no ' was incorrectly given as '21MMHIS164e ' but should have been '19CT037Ae '.Publisher's NoteSpringer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.By Po-Kai Huang; Chin-Kuo Chen; Yi-Hsuan Yu; Guan-Min Ho and Li-Chun HsiehReported by Author; Author; Author; Author; Author [Extracted from the article]