Neuromod Devices is planning to make its Lenire device available in Australia and would partner with audiologists and ENTs experienced in treating tinnitus, the company has confirmed.
The device sits in the mouth delivering mild pulses to the surface of the tongue to reduce symptoms and is accessed from healthcare professionals including audiologists and ENT surgeons.
It soothes tinnitus by pairing tongue and sound stimulation to help people pay less attention to tinnitus in a type of dual mode stimulation called bimodal neuromodulation.
Mr Joe Roche, Neuromod Device’s head of communications, said the company was ‘aware of the high demand in Australia for Lenire.’
“We intend to make Lenire available in Australia in the near future to the nearly five million Australians living with tinnitus,” he told Hearing Practitioner Australia.
“Neuromod partners with audiologists, ENT surgeons and healthcare professionals with experience treating tinnitus patients. As tinnitus is a subjective condition that manifests in different ways on a per patient basis, extensive experience in treating tinnitus patients is essential.
“Lenire receives a high volume of inquiry from hearing care practitioners and people living with tinnitus in Australia. This is unsurprising as recent data suggests that an estimated 17% – 20% of Australians live with some form of tinnitus.”
Neuromod has spent 14 years developing the treatment.
“Custom sounds are configured to a patient’s tinnitus profile,” Neuromod states. “While sounds play through headphones, Lenire’s Tonguetip sends safe electrical pulses to the tongue. This combination of sound and tongue stimulation supports long term tinnitus changes.”
Bimodal stimulation is sound stimulation using varying sounds combined with electric pulses to the tongue. Electric pulses add ‘stickiness’ to sound treatment, allowing the positive impact to compound over multiple treatment sessions, Neuromod claims.
Lenire is claimed to soothe tinnitus by pairing tongue and sound stimulation to help people pay less attention to tinnitus in a type of dual mode stimulation called bimodal neuromodulation. Photo: Eoin Holland for Neuromod Devices.
The company claims it has clinically proven Lenire’s safety, efficacy and tolerability through three clinical trials involving more than 600 tinnitus patients and real-world evidence. It said 91% of compliant patients in its second largest trial reported symptoms reduced from moderate to mild for at least a year after treatment, and 83% of participants said they would recommend it to treat tinnitus. In its third clinical trial it was more effective than sound alone for those with moderate or worse tinnitus, Neuromod said.
Lenire was the first device of its kind to receive an FDA De Novo Grant for the treatment of tinnitus in America. In August 2024 Nature Communications published results of the TENT-A3 (Treatment Evaluation of Neuromodulation for Tinnitus – Stage A3) clinical trial which were central to the FDA approval.
The trial demonstrated Lenire was clinically superior to sound-only stimulation for most patients with moderate or worse tinnitus. Additionally, 70.5% of participants with moderate or worse tinnitus who experienced no clinically meaningful improvement from six weeks of sound-only stimulation reported clinically significant improvement in their tinnitus severity after six weeks of Lenire treatment.
It also found 82% were treatment compliant and 88% said they would recommend Lenire as a tinnitus treatment.
The device became available in Spain, Norway, Denmark and Hungary in 2022.
US contract extends access to veterans
In June 2024, the US Government awarded Neuromod USA Inc a Federal Supply Schedule 65 II Medical Equipment and Supply Contract, making Lenire a treatment option for 2.9 million US veterans living with tinnitus through its Department of Veterans Affairs.
The contract also makes it an option for patients receiving care from the Department of Defense,Bureau of Prisons, Indian Health Services and Public Health Services.
Roche said he could not ‘at this moment in time, discuss Therapeutic Goods Australia (TGA) submission.’
A Department of Health and Aged Care spokeswoman told HPA that the TGA had not approved Lenire for supply in Australia. She said that by law, the TGA must not disclose whether it has, or does not have, an application for a particular medical device, as this was potentially commercially sensitive information.
“We therefore cannot tell you whether we have received an application for this product,” she said.
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