Sound-Paired Vagus Nerve Stimulation for Tinnitus
16.9.2026
Sound paired with vagus nerve stimulation for tinnitus
safe and feasible in an initial clinical study
A new study by Dirk De Ridder et al. investigated an experimental approach combining non-invasive vagus nerve stimulation with a sound that matches the participant's tinnitus as closely as possible.
The main conclusion:
The approach proved safe and feasible in this small study. The study does not yet demonstrate that the treatment effectively reduces tinnitus.
No significant differences were found between the study groups in tinnitus loudness or in the Tinnitus Functional Index, a measure of the broader impact of tinnitus.
Why combine sound with vagus nerve stimulation?
Tinnitus is the perception of sound without a corresponding external sound source. When tinnitus is accompanied by distress, it can affect sleep, emotional well-being, and quality of life, among other things.
This study investigated whether a sound resembling the tinnitus could be linked to a physical state of relaxation through a learning process.
To do this, the study used transcutaneous auricular vagus nerve stimulation: a non-invasive electrical stimulation via an electrode on the tragus of the ear.
The timing of the sound relative to the electrical stimulation was key.
The researchers hypothesized that simultaneous stimulation was associated with sympathetic activation, while a sound presented five seconds later was associated with parasympathetic activation. However, this assumed autonomic activation was not objectively measured in this study.
How was the study conducted?
The randomized, double-blind proof-of-concept study included 30 adults with chronic, purely tonal tinnitus. They were randomly assigned to three groups of ten participants each:
Simultaneous stimulation: the electrical stimulation and the tinnitus-like sound began at the same time.
Delayed stimulation: the sound began five seconds after the start of the electrical stimulation.
Uncoupled control condition: the electrical and auditory stimuli were presented at random intervals.
Each participant received nine sessions spread over three weeks. Their specific tinnitus sound was replicated as accurately as possible based on pitch, loudness, and perceived location in the head. Each treatment lasted approximately 30 minutes.
The researchers collected data before the treatment, immediately after the treatment period, and one month later. The primary question was whether the method was safe and feasible. In addition, tinnitus loudness, annoyance, general tinnitus impact, psychological complaints, sleep, and changes in brain activity were examined.
What were the results?
Safety and feasibility
No serious adverse effects were reported.
The reported effects, including local pain, warmth or tingling, and a temporary increase in tinnitus, were mild and transient.
No participant dropped out due to an adverse effect.
No demonstrated effect on loudness or general tinnitus impact
Between the three groups, no significant differences were found in the change in:
- tinnitus loudness
- the 'Tinnitus Functional Index' questionnaire
The study therefore provides no evidence that this approach makes tinnitus quieter or reduces its overall impact.
Preliminary signals for annoyance, sleep, and anxiety
In the group with delayed sound stimulation, the "annoyance" of the tinnitus decreased more significantly than in the group with simultaneous stimulation.
That difference was found both immediately after treatment and one month later. The average decrease immediately after treatment was 1.75 points, which was above the threshold for a minimal clinically important difference used in the article.
Sleep scores also improved in the delayed group compared to the concurrent group. In addition, anxiety scores decreased in the delayed group compared to the unmatched control group.
Extra caution is required with this last result: the delayed group already had higher anxiety scores at the start, which meant there was more room for a decrease.
These analyses were exploratory.
The study was not designed to prove efficacy, and no corrections were made for the large number of comparisons.
The findings should therefore be considered hypothesis-generating .
Exploratory EEG findings
The EEG analyses showed differences between the groups in brain regions and networks associated with tinnitus and the processing of unpleasant sound, including the auditory cortex, the insula, and the anterior cingulate cortex.
These results are also exploratory. They offer potential leads for further research, but do not prove that the intervention is clinically effective or works via the hypothesized mechanism.
How should we interpret this study?
The study primarily answers an initial research question:
"can this combination of non-invasive vagus nerve stimulation and an individually tailored tinnitus sound be applied safely and practically?"
Within this limited group, the answer to that was positive.
No definitive conclusion can yet be drawn regarding efficacy. There are several reasons for this:
- only 30 people participated, with ten participants per group;
- the study was primarily focused on safety and feasibility, not on demonstrating a clinical effect;
- the autonomic response to the stimulation was not measured objectively;
- the treatment period lasted only three weeks and the follow-up one month;
- there were no separate groups for sound only or vagus nerve stimulation only;
- the exploratory analyses were not corrected for multiple comparisons.
A larger, pre-registered study is needed to determine whether the preliminary changes in unpleasantness, sleep, and anxiety are reproducible and clinically relevant.
Such a study should also investigate whether the delayed timing actually induces the intended parasympathetic activation and whether potential effects persist in the longer term.
A research question for misophonia, not a research result
Because this study primarily observed a change in unpleasantness rather than loudness, it could be useful to further explore misophonia in future research.
In misophonia, specific sounds trigger a strong aversive reaction, making an approach focused on the unpleasantness of sound theoretically relevant.
However, misophonia was not investigated in this study.
All participants had chronic, purely tonal tinnitus.
The article therefore provides no evidence that this treatment is effective for misophonia; it merely formulates a hypothesis for future research.
Conclusion
This initial clinical study demonstrates that non-invasive vagus nerve stimulation combined with an individual tinnitus sound can be applied safely and feasibly.
No significant difference was found in tinnitus loudness or overall tinnitus impact.
The observed changes in unpleasantness, sleep, and anxiety are interesting, but preliminary and hypothesis-generating.
The next step is a larger, sufficiently powered study with pre-registered efficacy outcomes, correction for multiple comparisons, objective measurement of the autonomic response, and a longer follow-up.
Publication
Deng B, Adhia DB, van Sleeuwen C, Mansell I, De Ridder D. Sound-Paired Vagus Nerve Stimulation for Tinnitus: A Safety and Feasibility Trial. Neuromodulation. 2026. https://doi.org/10.1016/j.neurom.2026.08.002.