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Sci Rep. 2017 Sep 20;7(1):11960. doi: 10.1038/s41598-017-12178-w.

Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans.

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University of Iowa Department of Otolaryngology-Head and Neck Surgery and Communication Sciences and Disorders, The University of Iowa, Iowa City, IA, USA.
Department of Communication Sciences & Disorders, Wayne State University, Detroit, MI, USA.
Department of Communicative Disorders and Sciences, University at Buffalo, Buffalo, NY, USA.
MicroTransponder, Inc., 2802 Flintrock Trace, Suite 226, Austin, TX, USA.
Callier Center for Communication Disorders, School for Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX, USA.
Department of Speech-Language-Hearing Sciences, Hofstra University, Hempstead, NY, USA.
Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX, USA.
Lab for Clinical and Integrative Neuroscience, School for Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX, USA.


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.

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