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ACI Hearing Center is a certified Lenire provider. FDA-cleared bimodal neuromodulation for chronic subjective tinnitus, delivered as a 12-week home treatment with in-person check-ins.
Lenire is a medical device that treats chronic subjective tinnitus by combining sound with mild electrical stimulation of the tongue. Both signals reach the brain at the same time and, over a 12-week program, they change how your brain processes the tinnitus signal. Patients typically use the device at home for 30 to 60 minutes per day. This approach is called bimodal neuromodulation.
Lenire was developed by Neuromod Devices in Ireland and received FDA De Novo authorization (DEN220015) in March 2023. It is the first bimodal neuromodulation device authorized by the FDA for tinnitus in adults.
ACI Hearing Center is one of a small number of certified Lenire providers in Louisiana. Our Doctors of Audiology completed the Neuromod provider training and follow the manufacturer's clinical protocol for candidacy screening, fitting, and follow-up.
The Lenire device has two parts:
During each treatment session, sound and tongue stimulation are delivered together in a synchronized pattern. Delivering both signals at the same time drives measurable changes in the auditory pathway. Across the 12 weeks, most responding patients report their tinnitus becomes quieter, less intrusive, or easier to ignore.
Lenire is supported by two large randomized controlled trials:
Published in Science Translational Medicine by Conlon and colleagues. 326 adults with chronic subjective tinnitus. Bimodal neuromodulation produced statistically significant reductions in the Tinnitus Handicap Inventory and Tinnitus Functional Index compared to sound alone. Improvements were sustained at the 12-month follow-up. About 66 percent of participants who completed the protocol reported clinically meaningful improvement.
A second large trial that examined stimulation-parameter timing and confirmed durable tinnitus severity reductions in a broader patient population. Published in Nature Scientific Reports.
These two trials are why Lenire received FDA authorization and why we offer it. Every patient we start on Lenire is measured against these same outcome instruments, so we know whether it is working for you specifically, not just on average.
Most adults with chronic subjective tinnitus are candidates. The best results are seen in patients who fit these criteria:
Candidacy is confirmed at your tinnitus consultation. If you are not a candidate for Lenire, we have several other evidence-based options and we will walk you through them.
After your consultation, if Lenire is recommended and you decide to proceed, we order your device. About two weeks later you come in for fitting. We personalize the sound program to your hearing profile and tinnitus pitch, calibrate the Tonguetip, and train you on the daily home routine.
Daily 30 to 60 minute sessions at home. Most patients settle into a morning or evening routine. Week 4 check-in visit: we review your tinnitus scores, adjust stimulation parameters if needed, and answer questions.
Many responders start to notice changes in tinnitus loudness or how much attention it demands. Week 8 check-in visit: we re-administer the THI and TFI and adjust the program.
Improvements typically continue through week 12. End-of-program visit: full outcome measurement, comparison to your baseline scores, and a plan for the following months.
90-day outcome reassessment and check-ins as needed. In the pivotal trials, benefits were sustained at the 12-month mark for most responders.
Lenire is currently a private-pay treatment. ACI Hearing Center charges a flat 12-week package price that includes the device, all provider visits (candidacy, fitting, weeks 4, 8, 12, and the 90-day outcome check), and outcome measurement. There are no surprise add-on charges.
You get the price in writing at your consultation, before you decide.
Financing. Every Lenire treatment plan is eligible for financing through Cherry, CareCredit, and PowerPay. Qualified applicants can spread the cost over 12 to 60 months, often with 0% interest.
Insurance. Most Louisiana insurance plans do not currently cover Lenire because it is a newer FDA-cleared device. Coverage is starting to expand. We verify your specific plan at your consultation.
Yes. Lenire received FDA De Novo authorization (DEN220015) in March 2023 for the treatment of chronic subjective tinnitus in adults. It is the first bimodal neuromodulation device authorized by the FDA for tinnitus.
The device delivers personalized sound through bone-conduction headphones at the same time as mild electrical pulses to the tongue through a mouthpiece. Delivering both signals together drives changes in how the brain processes the tinnitus signal. Over 12 weeks the perceived loudness and impact of tinnitus typically decrease.
Most adults with chronic subjective tinnitus for at least three months are candidates. Best results are in patients whose tinnitus is stable, moderate to severe, and not caused by another treatable medical condition. Candidacy is confirmed at your consultation.
Lenire is a flat 12-week package price that covers the device, all provider visits, and outcome measurement. You get the price in writing at your consultation. Financing is available through Cherry, CareCredit, and PowerPay with 0% interest options for qualified applicants.
In the TENT-A1 and TENT-A2 trials, responders typically noticed measurable improvement within the first six weeks, with continued improvement through week 12. Benefits were sustained at 12-month follow-up. Individual response varies.
No. Lenire is a home treatment. You use the device 30 to 60 minutes per day at home. In-person visits are candidacy, fitting, weeks 4, 8, 12, and the 90-day outcome check.
Most Louisiana plans do not currently cover Lenire. Coverage is starting to expand. We verify your specific plan at your consultation. Financing spreads the cost when insurance does not cover it.
Reported side effects in clinical trials were mild: short-lived tongue tingling or metallic taste, mild headache, and dizziness. No serious device-related adverse events were reported.
The first step is a tinnitus consultation so we can measure your specific tinnitus profile and confirm candidacy. Call 337-223-9448 or use our online form to schedule. Most patients are seen within one to two weeks.
Related pages: Tinnitus Care Overview · What to Expect at Your Consultation · Hearing Aids with Tinnitus Programs · Financing Options
