An Irish-made device for treating tinnitus – a common, debilitating condition where people hear constant ringing or noises in their ears – has improved the symptoms of 95% of participants in a clinical trial.

The findings of a clinical trial of the Lenire device involving 191 participants at St James’s Hospital, Dublin published in the journal Nature, will be good news to the 8.7% of Irish people that suffer from tinnitus, according to a recent estimate in the Lancet.

“Tinnitus is a complex neurological condition,” explains Ross O’Neill, CEO of Neuromod, who designed Lenire with Stephen Hughes. “The brain perceives a sound or sounds which have no external source.”

“These phantom noises occur in the brain likely because the brain is rewiring itself to compensate for issues with sensory inputs elsewhere such as, but potentially not limited to, hearing loss,” adds O’Neill.

About one-quarter of all people with tinnitus report that their condition is distressing and debilitating and severely impacting their lives. It can be linked with social withdrawal, an inability to concentrate, an avoidance of loud places, anxiety, and depression.

People with tinnitus report hearing ringing or whistling sounds in their ears that do not come from the environment. It was originally thought to be a problem with the ear, but in recent decades medical researchers have regarded it as more of a brain problem.

One of the difficulties for doctors when it comes to tinnitus is that it cannot be measured by an MRI or another type of scan. The only way to assess symptoms is through patient questionnaires.

“Data from our own clinic shows that while a majority of people with tinnitus present to healthcare professionals such as GPS, ENTs, or audiologists, less than half had ever ended up trying a treatment,” says O’Neill.

“A lack of effective treatment options that consistently work for the vast majority of patients is an issue and remains a significant healthcare challenge, which is why we are so enthusiastic about this research,” O’Neill adds.

The device has Bluetooth headphones that play sounds, an intraoral device called a Tonguetip which looks like a lollipop and provides mild electrical pulses to the tongue, and a handheld controller the patient uses to control the timing and intensity of the treatment.

The sounds and electrical pulses work together to retrain the brain to reduce tinnitus symptoms by allowing patients to pay less attention to it,” says O’Neill.

The clinical trial conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin is the second such trial involving the device, the first being conducted in 2020.

In the first trial, participants were treated with the same sound and electrical stimulation from the device for 12 weeks.

In this latest trial, the stimulation changed halfway through the treatment; with the introduction of a delay period between a sound being played and an electrical pulse delivered to the tongue.

The change of stimuli led to a larger percentage of people seeing an improvement in their tinnitus symptoms and a reduction in the severity of those symptoms compared to the first trial.

The device can, the manufacturers say, be customised to suit the particular needs of the individual patient.

“Patients have an assessment of their tinnitus and hearing with an appropriately trained and qualified healthcare professional, such as an audiologist,” says O’Neill.

“Based on the results of the assessment, the sounds played and electrical pulses provided to the tongue can be chosen by the healthcare professionals from a number of settings to provide best treatment,” O’Neill says.

The device is available already from a number of clinics in Ireland and throughout Europe, with Neuromod planning to access other markets.

“Most recently we launched Lenire in Denmark two weeks ago bringing the number of European countries it’s available in to 10,” says O’Neill.