Our nervous system plays a central role in how we sense things in our environment, and modulating the signals that pass through our nerves can manipulate our brain in various ways. Neuromodulation is commonly used for pain relief and is being researched to help restore movement, sight, hearing, and cognitive function for those who are impaired.
It was this amazing technology that excited Dr. Ross O’Neill, founder and CEO of Dublin, Ireland based Neuromod Devices. Neuromod Devices has developed “Lenire,” a non-invasive therapy for patients with tinnitus, a debilitating symptom of several hearing-related diseases in which the patient constantly experiences noises from inside the ear. During our visit to the Med in Ireland conference in Dublin, we had the opportunity to sit down with Dr. O’Neill to learn more about tinnitus and how Lenire is bringing relief to those suffering from it.
Scott Jung, Medgadget: Tell us a little bit about your background.
Ross O’Neill: I studied electronic engineering and took a course in biomedical engineering. I fell in love with the nervous system, how it was essentially a network of sensors connected to a central processing unit. What really excited me was this emerging concept of neuromodulation, using electricity to shape the brain. I decided to do a PhD in this space, and the area of research that had interested me were illusory-perceptual disorders, where the brain, in response to something like loss of a limb, will fill the gap with some kind of pathological noise, like phantom limb pain. Tinnitus is the brain’s response to hearing loss. I found these illusory-perceptual disorders to be so intriguing and strange, and so I wanted to develop something that would bring together my two loves, neuromodulation and illusory-perceptual disorders.
Medgadget: How does the Neuromod system work?
Ross O’Neill: My PhD advisor had an idea to treat tinnitus with neuromodulation by stimulating the trigeminal nerve. It’s been thought that this nerve links to the auditory system and basically “turns down the volume” of self-generated sounds, like our own speech. We hypothesized that if we could pair sounds within the bands of tinnitus noise with trigeminal nerve stimulation, we might be able to reverse the pathologies that give rise to tinnitus.
Our device is a handheld unit that generates the signals. There are two output devices: a standard set of Bluetooth headphones that play sounds through the ear, and a intra-oral electrode that we call the “tonguetip” that goes in the mouth like a lollipop that stimulates the trigeminal nerve. For 30-60 minutes a day, you undergo a treatment session that involves sound through the ears synchronized with electrical pulses you feel on your tongue.
We’re not the only researchers doing this; Dr. Susan Shore at the University of Michigan is also developing in this area, so we’re kind of in a friendly race, which I think is great for driving innovation faster which will benefit patients.
Medgadget: Just how bad of a problem is tinnitus?
Ross O’Neill: Tinnitus affects one in 10 adults in some way, two percent very severely. It’s caused my a number of factors, such as damage of the hair cells in the ear, conductive hearing loss, or auditory nerve compression. In the United States in particular, tinnitus is a massive and expensive epidemic for veterans. Tinnitus patients noise at levels up to 85 dB, as loud as a Dyson vacuum cleaner! The auditory perception of tinnitus can be high-pitched ringing, low-frequency noise, even cricket-like chirping, and each ear can have a different perception. Irrespective of the perception itself, it can cause severe emotional disturbances, attention difficulties, poor sleep, and other quality-of-life effects. And right now, the only standard of care for tinnitus is CBT (cognitive behavioral therapy), which deals more with managing the psychological impact of the condition. Hearing aids and sound therapy are also not effective, which shows how large of an unmet need tinnitus truly is.
Medgadget: How effective has Neuromod been shown to be?
Ross O’Neill: We conducted two randomized, double-blind studies with 326 and 191 participants, treating for 12 weeks and following up for 12 months. In the first study, we saw that 2/3 of the participants showed clinically significant improvement within the first 6 weeks of treatment and marginal improvement in the second 6 weeks. These effects lasted for 12 months. In the second study, we wanted to see why participants were only showing marginal improvement in the second 6 weeks; we believe it was due to a neural phenomenon called habitation where your nervous system adapts to signals that don’t vary much. We decided to change the stimulation settings in the second 6 weeks and observed further improvements, as well as an overall improvement rate of 80%!
Medgadget: Those results are absolutely astounding! What should physicians and their patients know about how to get a neuromod device?
Ross O’Neill: We’re CE marked and have expansion strategies in place for Europe. We’re hoping to open centers of excellence in several countries to work with and train doctors and audiologists about our device and educate more about the prevalence of tinnitus. Once we gain more credibility and can successfully scale the business in Europe, then we’ll look abroad to the US and other markets. We are already working on FDA clearance, as well, but bi-modal neuromodulation is a groundbreaking, new technology that will be very challenging, but also very exciting.