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PROLARYN PLUS clinical study results

PROLARYN PLUS was evaluated in a multicenter, open-label, prospective clinical study.1

STUDY DESIGN: Each patient served as his/her own control. A 5-point rating scale of vocal effort was used: greatly improved, significantly improved, somewhat better, no change, worse. Patients also rated the amount of effort they felt was required for phonation using a 100-point visual analog scale (the higher number, the more effort upon phonation).1

At 12 months, both patients and physicians reported:

Nearly 70% of patients (n=63) had "greatly improved" or "significantly improved" voice.1

Patient- and physician-observed improvement was confirmed by stroboscopic documentation of vocal fold augmentation and glottal closure.1


Stroboscopy was used to evaluate vocal fold vibratory and closure features at each patient visit. At baseline the duration of closure in 85% of patients was classified as always open or predominantly open. In contrast, the 12-month evaluation found that only 20% of treated patients had always open or predominantly open durations of closure.

Which patients are candidates for PROLARYN PLUS?

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  1. Rosen CA, Gartner-Schmidt J, Casiano R, et al. Vocal fold augmentation with calcium hydroxylapatite: twelve-month report. Laryngoscope. 2009;119:1033-1041.