So this publication came out today on Neosensory - bimodal stimulation of a wristband and tonal matching. The group size was relatively small but the researchers were well aware of a possible placebo effect. There is a reported 21 TFI point reduction in patients with a TFI of 50+ which is very good.
Bimodal stimulation for the reduction of tinnitus using vibration on the skin
Abstract
Tinnitus (ringing in the ears) affects 1 in 10 adults in the United States, often with damaging psychological consequences. Currently, there exists no cure for most forms of tinnitus. Recently, bimodal stimulation – the pairing of sounds with haptic stimulation – has shown efficacy in reducing the symptoms of tinnitus. Previous bimodal stimulation approaches have used electrical shocks on the tongue, a technique that requires daily in-person sessions at an audiologist's office. We here show that excellent results can be achieved wearing a wristband with multiple vibratory motors. Tones are played and the wristband correspondingly vibrates the wrist of the user at different spatial locations depending on the frequency of the tone. We compared the experimental group with a control group who listened to the tones but did not wear the wristband. The tone frequencies were centered on each user's tinnitus frequency and the tones were randomized both in frequency and duration. 45 participants with Tinnitus Functional Index (TFI) scores of 25 and above were tested. Results show a significantly greater reduction in TFI scores for the experimental group compared to the control. Importantly, with higher baseline severity we find larger differences between the experimental and control groups, revealing greater symptom improvement for those with severe tinnitus. The therapeutic approach of combining sounds with spatially- and temporally-correlated vibrations on the wrist is found to be a simple, time-efficient, and effective procedure to lessen the symptoms of tinnitus.
Results
Participants in the experimental group (tones paired with simultaneous vibrations of the wristband) showed a clinically-significant average improvement in TFI scores of -17.9 (SD = 18.17, n = 22, p<.001, two-tailed t-test; Figure 2A). Interestingly, the audio-only control group also showed a significant difference from baseline of - 7.5 (SD = 15.35; n = 23; p=.03, two-tailed t-test); however, it is important to note that a change in TFI score of less than -13 is not considered clinically significant (Meikle et al. 2012), so while the audio-only control showed a change, it was not clinically meaningful. The difference between the experimental and control groups was statistically significant (t(43) = 2.10, p=.04).
Importantly, participants who started the study with greater severity of tinnitus (as measured by their baseline TFI score) experienced greater improvement from the bimodal stimulation. The difference between experimental and control groups increased with higher baseline TFI scores: for baselines of 50 and above, the experimental group averaged -21.8 (SD=14.6; n=18; p<.001) while the control group averaged -4.6 (SD=15.0; n=18; p=.24); the significance of the difference increased to p=0.002 (two-tailed, t(32) = 3.39).