Objectives/Hypothesis: There are several implants available for injection medialization of the vocal folds. None are ideal. The purpose of this investigation is to evaluate the safety and efficacy of a new FDA-approved implant for injection augmentation of the vocal folds (Novielle, Coapt Systems Inc, Palo Alto, CA). Study Design: Prospective Cohort Methodology: Individuals undergoing injection augmentation of the vocal folds with Novielle from April 2008 to present were prospectively evaluated and followed. Patients underwent strobovideolaryngoscopy, acoustic analysis, and vocal assessment with the 10-item Voice Handicap Index. Pre- and post-injection data was compared with the matched-pairs ttest. Results: 31 patients were prospectively evaluated. The mean age of the cohort was 68 years. Sixtyone percent was male. The diagnoses were 18 unilateral vocal fold paralyses, 4 vocal fold pareses, 9 presbylarynx. The mean VHI at entry was 27 (+/- 7.4). This improved to a mean VHI of 18 (+/- 9) at one month postoperatively (p < 0.00) and 19 (+/- 11) at three months (p=0.00). The mean follow-up time was 93 days. There was no evidence of adverse reaction to the implant or procedurerelated complications. Conclusion: Initial data suggests that Novielle Voice Gel is a safe and effective implant for medialization of the vocal folds. Intermediate and long-term follow-up is necessary to ensure enduring safety and efficacy.
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