Vagus nerve stimulation paired with tones for tinnitus suppression: Effects on voice and hearing

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.