Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind...

The aim of the pilot study was to evaluate the effect of Vagus Nerve Stimulation (VNS) paired with sounds in chronic tinnitus patients. All participants were implanted and randomized to a paired VNS (n = 16) or control (n = 14) group. After 6 weeks of home therapy, all participants received paired VNS. The device was used on 96% of days with good compliance. After 6 weeks, the paired VNS group improved on the Tinnitus Handicap Inventory (THI) (p = 0.0012) compared to controls (p = 0.1561). The between-group difference was 10.3% (p = 0.3393). Fifty percent of the participants in the paired VNS group showed clinically meaningful improvements compared to 28% in controls. At one year, 50% of participants had a clinically meaningful response. The therapy had greater benefits for participants with tonal and non-blast induced tinnitus at the end of 6 (24.3% vs. 2%, p = 0.05) and 12 weeks (34% vs. 2%, p = 0.004) compared to controls with 80% and 70% responding at 6 months and 1 year, respectively. Adverse effects were mild and well-tolerated and the therapy had a similar safety profile to VNS for epilepsy. VNS paired with tones may be effective for a subgroup of tinnitus patients and provides impetus for a larger pivotal study.