The Therapeutic Goods Administration (TGA) has approved Neuromod Devices’ Lenire tongue stimulation device for use by tinnitus patients in Australia, with audiologists and ENT surgeons likely to have major roles in its prescription and management.
A TGA spokesperson told HPA that it had approved the Lenire tinnitus therapy auditory/translingual electrical stimulation system on 11 September 2025. It listed it as a medical device included class 11a on the Australian Register of Therapeutic Goods.
The listing states: “Lenire device is intended to be used by tinnitus sufferers of at least 18 years of age to alleviate the symptoms of chronic, subjective tinnitus.
“It should be used for 30 to 60 minutes per day, every day, for at least 10 weeks, after which you may experience sustained alleviation of your tinnitus symptoms.
“The Lenire device can be used in the home environment after consultation and fitting by a suitably qualified healthcare professional. Lenire is intended for prescription use only. Use by a person for whom the device has not been configured may cause discomfort, or temporary exacerbation of tinnitus loudness.”
In a media release, Neuromod Devices said: “Patients with tinnitus are prescribed Lenire by an appropriately qualified healthcare professional, such as an audiologist or ENT surgeon, after an assessment for suitability and can complete treatment from home in between follow-up appointments with their clinician.”
Neuromod Devices, the global medical technology company that created Lenire, announced approval to the European Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (MDR) certification. It said MDR certification supported the continued availability of Lenire in the European market and enabled further availability of Lenire beyond Europe.
Dr Ross O’Neill, Neuromod founder and CEO, said, in a media release on 23 September 2025: “Neuromod’s commitment to delivering the highest quality of patient care begins with ensuring our quality management systems are best-in-class.
“MDSAP and MDR certification allow Neuromod to continue expanding Lenire’s availability in Europe while positioning the company to commercialise Lenire in new geographies such as Australia, Canada and beyond.”
MDSAP certification was an essential milestone towards commercialisation of the device in Australia and Canada. After this, Neuromod secured regulatory approval from the TGA and Health Canada.
In 2023 Lenire became the first and only FDA (Food and Drug Administration) approved bimodal neuromodulation tinnitus treatment device in the US.
Neuromod said MDSAP certification came after “a comprehensive audit verifying compliance with the international standard ISO13485” and specific regulatory requirements in multiple regulatory jurisdictions including Canada and Australia.
MDR governs the market placement, safety, and performance of medical devices in Europe, replacing the Medical Device Directive (MDD) regulatory framework. MDR introduced significantly more rigorous requirements than MDD to ensure safety, quality, and reliability of medical devices throughout their lifecycle, the media release, Neuromod said.
“Neuromod’s simultaneous approval to MDR and MDSAP assures our healthcare provider partners, and their patients, that Lenire meets the highest safety, quality, and evidence threshold for a tinnitus treatment device,” said Mr Diarmuid Flavin, Neuromod’s chief operating officer.
“The transition from MDD to MDR in Europe introduced more rigorous standards for medical device approval. Globally, many non-European markets recognise these standards which paves the way for us to make Lenire available to more people living with tinnitus worldwide.”
Neuromod said Lenire was the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials.
In 2023, Lenire made regulatory history by becoming the first and only bimodal neuromodulation device to be granted De Novo approval by the US FDA. The De Novo grant was awarded based on results of TENT-A3, a controlled clinical trial of the device in 112 people.
Another study of 220 tinnitus patients treated with Lenire in a real-world clinical setting published in Nature Communications Medicine in April 2025 found 91.5% reported clinically meaningful reductions in tinnitus after treatment with Lenire. Neuromod said these results were consistent with Lenire’s large-scale clinical trials.
Tinnitus, commonly known as ringing in the ears, is a complex neurological condition that affects 15% of the global adult population.
Stimulation of nerves
Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for therapeutic purposes. Lenire consists of wireless (Bluetooth) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip.
The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli.
Timing, intensity and delivery of stimuli are controlled by a handheld controller that each participant is trained to use before continuing treatment from home.
