Lenire is a tinnitus treatment device that pairs sound delivered through headphones with mild electrical pulses on the tongue. It was added to the Australian Register of Therapeutic Goods in September 2025 and became available through Australian clinics from September 2026. The Audiology Place is one of only two providers in New South Wales.
This page covers what the device is approved for in Australia, who can access it, what the process involves and what it costs. If you want the clinical evidence rather than the practical detail, read what the Lenire trials actually show.
What Lenire is approved for in Australia
Lenire is included in the Australian Register of Therapeutic Goods as a Class IIa medical device under ARTG entry 511728, sponsored by MDSS AU Pty Ltd and described as a tinnitus therapy auditory and translingual electrical stimulation system.
The device is intended for adults aged 18 and over with chronic subjective tinnitus, which is tinnitus only you can hear. It is supplied through clinics rather than sold direct to the public, and it is fitted and configured by a clinician after an assessment.
Two points about the wording matter, because both are commonly overstated. Under Australian law it is not permitted to describe a therapeutic good as “TGA approved” in advertising. The correct description is that the device is included in the ARTG. The United States Food and Drug Administration granted Lenire a De Novo authorisation in 2023 under reference DEN210033, with an indication to temporarily relieve the symptoms of tinnitus in patients aged 18 and over with at least moderate tinnitus. De Novo is a classification pathway for novel devices of low to moderate risk. It is not the same as premarket approval, and the word “temporarily” is part of the official indication.
Who can access it
You do not need a GP referral. What you do need is an assessment, because Lenire is not suitable for everyone and the evidence for it is strongest in a specific group.
The device is designed for subjective tinnitus in adults. It has not been evaluated for Meniere’s disease, and it is contraindicated for objective tinnitus, where the sound has a physical source such as a blood vessel or muscle. There is a list of medical contraindications covering pacemakers and other active implants, pregnancy, epilepsy, impaired tongue sensation, oral sores or lesions, head and neck neuralgia, and oral piercings.
The clinical trial data also shows the benefit concentrates in people whose tinnitus is at least moderately bothersome. In people with mild tinnitus, the addition of tongue stimulation did not clearly outperform sound therapy alone. We cover the eligibility question in detail in are you a candidate for Lenire.
What the process involves
The first appointment runs around 90 minutes. It includes a full hearing assessment if you have not had one recently, a tinnitus history, and validated questionnaires that measure how much the tinnitus is affecting you. The Tinnitus Handicap Inventory and the Tinnitus Functional Index are the two instruments used in the Lenire trials, and we use the same ones so that your progress can be measured against published data rather than impression.
If you are suitable, the device is configured to your hearing profile and your tinnitus characteristics. You then use it at home for two 30-minute sessions a day over a minimum 12-week course, with review appointments at around six weeks and twelve weeks. The six-week review is where settings are adjusted, and in the trials the second stimulation setting mattered to the result.
Some people notice change within the first few weeks. Others do not see much until later in the course, and some do not respond at all. The trials measured outcomes at 12 weeks for a reason.
What it costs
If Lenire is suitable for you, the treatment program is $7,990 and includes the Lenire device, fitting and set-up, along with professional follow-up care over a six-month period.
Our aim is not simply to provide a device, but to understand your individual experience of tinnitus and recommend the treatment approach that is most appropriate for you.
Lenire is not funded under Medicare and is not available through the Australian Government Hearing Services Program. Some private health funds may contribute under certain extras policies, but this is not consistent across funds and you would need to check with your insurer directly, quoting the device rather than a hearing aid item. We will give you the information you need to make that enquiry.
We publish the price because a treatment at this level should not require a phone call to find out what it costs. If the number does not work for you, that is worth knowing before you book rather than after.
Where you can get it in New South Wales
Lenire is supplied only through clinics that have completed the provider training. There are two in New South Wales, and The Audiology Place is one of them.
We see Lenire patients at both of our clinics:
- Forestville, 12/14 Starkey Street, serving the Northern Beaches and lower North Shore
- Epping, Shop 3, 22-28 Cambridge Street, serving Epping, Eastwood, Carlingford, Beecroft, Ryde and the surrounding northern suburbs
Because there are only two providers in the state, we see people from well outside both catchments, including the Central Coast, the Hunter and the Illawarra. The initial assessment has to be in person. The review appointments can often be handled remotely for people travelling a long way, and we will work that out with you at the first visit.
Is it worth it
That depends on how much your tinnitus is affecting you and how you weigh the evidence, which is genuinely mixed rather than uniformly positive.
The honest summary: across the published trials, most people with at least moderate tinnitus report a meaningful reduction in how much it bothers them, and in the largest trial roughly nine in ten of those who responded still had that benefit twelve months after finishing. The device does not remove the sound, and a controlled trial found that in people with milder tinnitus the tongue stimulation added little over sound therapy alone. Around a third of trial participants had a temporary increase in tinnitus during treatment.
Lenire is a treatment, not a cure, and it is one option among several. Hearing aids, sound therapy and cognitive behavioural therapy all have a place, and for some people they are the better starting point. The assessment exists to work out which of those applies to you.
Frequently asked questions
Is Lenire available in Australia?
Yes. Lenire was included in the Australian Register of Therapeutic Goods in September 2025 and became available through Australian clinics from September 2026. It is supplied only through trained provider clinics, not sold direct to consumers.
Do I need a referral from my GP?
No. You can book an assessment directly. If your history suggests something that needs medical investigation first, such as tinnitus in one ear only or pulsatile tinnitus, we will tell you and refer you appropriately.
Does Medicare cover Lenire?
No. Lenire is not covered by Medicare and is not funded under the Hearing Services Program. Some private health extras policies may contribute. Check directly with your fund.
How long does the treatment take?
Two 30-minute sessions each day at home, over a minimum of 12 weeks, with clinic reviews at approximately six and twelve weeks.
Where can I get Lenire in NSW?
There are two provider clinics in New South Wales. The Audiology Place offers Lenire at Forestville on the Northern Beaches and at Epping.
Book a Lenire assessment
If your tinnitus is affecting your sleep, your concentration or your mood, the assessment is the starting point whether or not Lenire turns out to be right for you. Call (02) 9315 8327 or book online.
References
- Therapeutic Goods Administration. ARTG entry 511728: Lenire tinnitus therapy auditory/translingual electrical stimulation system. Australian Government Department of Health, Disability and Ageing.
- Therapeutic Goods Administration. Labelling and advertising for medical devices.
- US Food and Drug Administration. De Novo classification order DEN210033, Lenire, 2023.
- Conlon B, Langguth B, Hamilton C, et al. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Science Translational Medicine. 2020;12(564). doi:10.1126/scitranslmed.abb2830
- Conlon B, Hamilton C, Meade E, et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Scientific Reports. 2022;12:10845. doi:10.1038/s41598-022-13875-x
- Boedts M, Buechner A, Guerit F, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nature Communications. 2024;15. doi:10.1038/s41467-024-50473-z
- Neuromod Devices. What patients are unsuitable for Lenire?
Reviewed by Dr Signe Steers, Audiologist, The Audiology Place. Last updated September 2026. This article provides general information and is not a substitute for individual clinical assessment.
Always read the instructions for use. Follow the instructions for use. If symptoms persist, talk to your health professional.
