By Barry Keate
A clinical study using a novel medical device shows it can reduce tinnitus in most people. While the study did not use a control group, it showed that the majority of people who responded positively maintained a modest average reduction for up to one year after the therapy ended. The device delivers sound therapy to the ears and a series of mild electrical shocks to the tongue.
This study has been covered by several online business and science news outlets and has generated considerable enthusiasm and many questions from the tinnitus community.
Neuromod Devices Limited, an Irish medical device company that specializes in the treatment of chronic tinnitus, has published the results of the company’s clinical trial in an October 2020 edition of Science Translational Medicine, titled “Bimodal Neuromodulation Combining Sound and Tongue Stimulation Reduces Tinnitus Symptoms in a Large Randomized Clinical Study”. (1)
The clinical trial was conducted between 2016 and 2019 and used a device trademarked by Neuromod as Lenire®. There were 326 enrolled patients in the trial. They were instructed to use the device for 60 minutes daily for 12 weeks. 86.2% of those who were compliant with the treatment reported an improvement in tinnitus symptoms when evaluated after 12 weeks. Many patients experienced sustained relief 12 months after treatment.
There was no control group in the trial. Without that, says Oxford neuroscientist, Victoria Bajo, it’s impossible to know how much patients would have improved on their own or with a placebo. In major clinical trials, results from the active therapy are compared to results from the placebo therapy. The difference is the proof of whether the therapy is effective or not. The work is good, she says, “but this is just the beginning.” There is much more research to be conducted to fine-tune the device and provide proof of its effectiveness.
Lenire Device for Tinnitus
The Lenire device consists of three parts; a hand-held controller, wireless Bluetooth headphones, and a proprietary device trademarked as Tonguetip®, which connects the controller to a pad which has 32 stimulation electrodes that connect to the tongue.
The headphones produce sounds that are targeted to the brain’s auditory system. Each person hears a rapidly changing series of pure tones at different frequencies, against a background noise that sounds like electronic music. The electrical stimulation of the tongue feels like fizzing from pop rocks candy, a carbonated candy that fizzes when placed in the mouth.
The theory behind the use of bimodal treatment is hearing loss causes the brain to overcompensate for the frequencies it no longer hears. Stimulating the tongue broadly excites the brain. Coupled with the sounds, which are targeted to the brain’s auditory system, the two can distract the brain by heightening its sensitivity, forcing it to suppress the activity that causes tinnitus.
Tinnitus Results using Lenire
Participants had an average drop of 14 points on the Tinnitus Handicap Inventory, a questionnaire that evaluates tinnitus severity on a scale of 1 to 100. When followed up on 12 months later 80% of the participants still had lower THI scores.
A 2018 study that stimulated the cheek and neck over a shorter period of time improved tinnitus but the average dip in scores was only 7 points.
Cognitive behavioral therapy, which is currently the primary clinical tinnitus therapy, improves tinnitus severity scores by about 10 points.
Availability of Lenire for Tinnitus
Lenire is a medical device and will only be available by prescription through a medical clinic. The sounds and electrical stimulation must be programmed individually to a patient’s needs. While I was unable to find pricing for the device, I surmise it must be fairly expensive.
Lenire is also not available in the US and has not been approved by the FDA for distribution here. There are 6 clinics in the world that are able to distribute Leniere. Four are in Germany, one is in Belgium and one is at Neuromod’s headquarters in Dublin, Ireland.
I am not totally impressed by a device that reduces tinnitus sounds by 14 points on a 100-point scale. While people are desperate for some relief, especially those with severe tinnitus, this may be helpful but doesn’t appear to be a game changer. Over time, Arches Tinnitus Formula can reduce tinnitus levels caused by hearing loss, by up to 50 – 75%.
The ingredients in Arches Tinnitus Formula have been shown in numerous double blind, placebo-controlled trials to be effective for most people who have tinnitus. It must be used for three months to provide the full benefit so we recommend Arches Tinnitus Starter Kit, a full three-month supply of four bottles.
1 – Bimodal Neuromodulation Combining Sound and Tongue Stimulation Reduces Tinnitus Symptoms in a Large Randomized Clinical Study. Conlon B, Langguth B, Hamilton C, et al. Sci Transl Med. 2020 Oct. 7;12(564):eab2830.