Irish medical device company Neuromod Devices has received approval to treat tinnitus in the US market with its non-invasive device Lenire.
It said at least 25,000,000 Americans are suffering from tinnitus, of which 2,700,000 are veterans.
The FDA approval is based on results of a 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients.
"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’ Founding CEO.
"Lenire is the first bimodal neuromodulation device to go through the rigors 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," he added.
Following the FDA's granting of approval, Neuromod will train Audiologists and ENT Surgeons specialising in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.
