Abstract
OBJECTIVE: In individuals with chronic tinnitus, our interest was to determine whether daily low-level electrical stimulation of the vagus nerve paired with tones (paired-VNSt) for tinnitus suppression had any adverse effects on motor-speech production and physiological acoustics of sustained vowels. Similarly, we were also interested in evaluating for changes in pure-tone thresholds, word-recognition performance, and minimum-masking levels. Both voice and hearing functions were measured repeatedly over a period of 1 year. STUDY DESIGN: Longitudinal with repeated-measures. METHODS: Digitized samples of sustained frontal, midline, and back vowels (/e/, /o/, /ah/) were analyzed with computer software to quantify the degree of jitter, shimmer, and harmonic-to-noise ratio contained in these waveforms. Pure-tone thresholds, monosyllabic word-recognition performance, and MMLs were also evaluated for VNS alterations. Linear-regression analysis was the benchmark statistic used to document change over time in voice and hearing status from a baseline condition. RESULTS: Most of the regression functions for the vocal samples and audiometric variables had slope values that were not significantly different from zero. Four of the nine vocal functions showed a significant improvement over time, whereas three of the pure tone regression functions at 2-4 kHz showed some degree of decline; all changes observed were for the left ear, all were at adjacent frequencies, and all were ipsilateral to the side of VNS. However, mean pure-tone threshold changes did not exceed 4.29 dB from baseline and therefore, would not be considered clinically significant. In some individuals, larger threshold shifts were observed. No significant regression/slope effects were observed for word-recognition or MMLs. CONCLUSION: Quantitative voice analysis and assessment of audiometric variables showed minimal if any evidence of adverse effects using paired-VNSt over a treatment period of 1 year. Therefore, we conclude that paired-VNSt is a safe tool for tinnitus abatement in humans without significant side effects. LEVEL OF EVIDENCE: Level IV.