A new paper published this week in Science Translational Medicine explores whether Neuromod Devices’ Lenire®, a bimodal neuromodulation device, delivers a reduction in tinnitus symptoms.

Why?

The objective of the study was to investigate bimodal neuromodulation, combining sound and tongue stimulation, to determine whether it is safe and effective for treating individuals with chronic subjective tinnitus.

The trial consisted of three study groups, with the aim of evaluating the effects that three different stimulation settings have on tinnitus symptoms.

Who?

The study recruited 326 adults with chronic subjective tinnitus who were/had:

  • aged between 18 and 70
  • a tinnitus duration of three months to five years
  • a Tinnitus Handicap Index (THI) score of 28 to 76 points

How?

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.

They 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.

The results

81% of participants experienced an improvement in tinnitus symptoms after 12 weeks of treatment and 77% at 12 months post-treatment, irrespective of the study arm they were on (based on THI and TFI scores). 16% of participants reported that their tinnitus got worse. At the end of treatment, 66.5% of participants said that they had benefitted from using the device.

The study also found that there wasn’t as large of an improvement in tinnitus symptoms during the second 6-weeks of stimulation, as there was during the first 6-weeks. This suggests that the brain may become less sensitive in response to repetitive stimuli over time.

Things to consider

This paper is the first high quality paper evaluating the effectiveness of a bimodal neuromodulation device (Lenire®) to reduce the perception of tinnitus. However, it is sponsored by Neuromod Devices so is not fully independent.

Further clinical trials are required before bimodal neuromodulation could be established as a clinically recommended treatment for tinnitus.

The study excluded a number of potential candidates, including those with:

  • tinnitus for longer than 5 years
  • objective tinnitus or somatic tinnitus caused by a head or neck injury, or if their tinnitus was occurring alongside a neurological condition
  • conductive or substantial sensorineural hearing loss
  • a hearing aid used within 90 days prior to eligibility
  • Meniere’s disease

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study by Conlon et al, October 2020.