Neuromod Device’s treatment is first of its kind signed off by US regulators.
A tinnitus treatment developed by Irish company Neuromod Devices has been granted approval in the US market.
Lenire, which is a non-invasive treatment for the condition, is the first treatment of its kind to be given the green light in the market, the Irish firm said.
The US Food and Drug Administration (FDA) approval comes following a clinical trial that included more than 100 patients, and confirmatory real-world evidence from more than 200 others. Lenire delivers sound to the ears and electrical stimulation to the tongue.
The move will open up the treatment to at 25 million Americans who suffer from the complex neurological condition commonly known as “ringing in the ears”, with more than 2.7 million veterans included in that number.
“Lenire’s approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients,” said Ross O’Neill, Neuromod Devices’ chief executive. “Lenire is the first bimodal neuromodulation device to go through the rigours of the FDA’s De Novo process. For patients that are at least moderately impacted by their tinnitus, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.”
The trial saw more than 79 per cent of patients who were at least moderately affected by tinnitus experience a clinically significant improvement.
The treatment will be available to US patients from next month. Patients with tinnitus will be prescribed Lenire by a healthcare professional, such as an audiologist or ENT surgeon, after being assessed for suitability. Treatment can be completed from home in between follow-up appointments with their clinician.
