Nic Wray, BTA Communications Manager takes a look at the new paper published in Nature – Scientific Reports which explores whether Neuromod Devices’ Lenire®, a bimodal neuromodulation device, delivers a reduction in tinnitus symptoms.

What is bimodal neuromodulation?

Bimodal neuromodulation involves stimulating two sets of nerves at the same time. In this trial, it is delivered by a commercially available device called Lenire®, developed by Neuromod. It consists of wireless (Bluetooth) headphones that play sequences of audio tones and a small paddle which delivers electrical pulses to the tongue.

Why was this trial conducted?

A previous study (TENT-A1) had delivered some promising results but more work was needed. The objective of this new trial – called TENT-A2 - was to see if the results of TENT-A1 could be repeated, and to build on the previous work, including investigating whether changing the stimuli used would lead to a greater improvement in tinnitus symptoms than shown in TENT-A1 and whether the background noise feature was needed for the treatment to be effective.

Who took part?

The study consisted of 191 adults, all of whom have chronic subjective tinnitus and who were/had:

  • aged between 18 and 70
  • tonal tinnitus
  • tinnitus for three months to 10 years
  • a Tinnitus Handicap Inventory (THI) score of 38 points or higher

What were they asked to do?

The participants were provided with and instructed to use a bimodal neuromodulation device Lenire®) – that delivers sound to the ears and electrical stimulation to the tongue – for 60 minutes daily for 12 weeks.

The stimuli were changed at the six-week point to see if this change made the treatment more effective.

Participants were clinically evaluated during the treatment period – at week 6 and at week 12. When treatment was completed, participants were assessed at three follow-up visits up to 12 months after returning their device.

Assessment was made via the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI).

The results

In the first 12 weeks of the trial over 80% of people were judged to be ‘treatment compliant’ - this means that they were using the device for at least an hour per day. This showed that the treatment is acceptable to a wide range of people.

At the 6-week assessment, some of the participants showed statistically significant reductions in THI and TFI scores. The change in THI scores was above that thought to show a clinically significant improvement, and in the TFI just below.

At the 12-week assessment, (following six weeks of a different stimuli), these reductions were larger and both over the change needed to show clinically significant improvement. The study also found that 95% of treatment-compliant participants had a reduction in THI scores and 84% had a reduction in TFI scores.

For those who responded to the 12 months follow-up, the improvements in tinnitus symptom severity were sustained. 91% of those followed up had a reduction in THI scores and 85% in TFI scores. This relates to 53% and 49% of all participants.

At the end of the 12-week treatment, 63.4% of those taking part said that they had benefitted from using the device.

The device appears to be safe, with no serious adverse events but 71 people across the study groups (over a third of participants) reported increased tinnitus during or after the treatment period, although for most this seemed to resolve by the end of the follow-up period.

Things to consider

  • This paper is the second of its kind that evaluates the effectiveness of a bimodal neuromodulation device (Lenire®) to reduce the perception of tinnitus. However, the paper is sponsored by Neuromod Devices so is not fully independent.
  • All study groups were active treatment groups and no control group or waiting list control was included. This means that we don’t know if people would have noticed an improvement over 12 weeks even if they had not used the device.
  • Long-term results are difficult to judge accurately, as almost 40% of participants (76 people) did not complete the final follow-up at 12 months. It is not known whether this was because the participant had found the device effective or not.
  • Although the inclusion criteria were broader than the previous study, several potential candidates were excluded including those with:
    • tinnitus for longer than ten years
    • pulsatile tinnitus, objective tinnitus or somatic tinnitus caused by a head or neck injury, or if their tinnitus was occurring alongside a neurological condition
    • severe/profound hearing loss
    • a hearing aid first used within 90 days prior to eligibility
    • Ménière's disease

Our conclusion

While the results of this study are promising, further independent clinical trials must be conducted before bimodal neuromodulation could be established as a clinically recommended treatment for tinnitus.


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