- Total providers treating patients with Lenire will be more than 50 by October 2023
- Neuromod is managing a phased onboarding process for Lenire providers in USA
- Lenire is the first device of its kind granted approval by US FDA for the treatment of tinnitus
October 10, 2023, Chicago, Illinois – Neuromod Devices has completed the training and onboarding of additional healthcare professionals in the USA to treat tinnitus patients with Lenire, its bimodal neuromodulation device. This brings the total Lenire providers in the USA to more than 50 with newly onboarded practices treating patients with Lenire starting October 2023.
This expansion follows Lenire’s launch in the USA in April 2023 when the company trained a first round of practices nationwide and meets significant patient demand. Following the announcement of Lenire’s FDA Approval in April, nearly 15,000 tinnitus patients have requested an assessment for treatment with Lenire.
Lenire is a bimodal neuromodulation device that reduces tinnitus severity by playing sound through Bluetooth headphones while simultaneously stimulating the tongue with mild pulses from the device’s proprietary Tonguetip component.
Neuromod is onboarding providers with multiple on-demand clinical training modules that complement in-person training events. These events include hands-on sessions with tinnitus specialists who were previously trained to treatment patients with Lenire. Neuromod’s clinical team also supports new providers during their first patient appointments with in-person visits.
“We know there are many healthcare professionals throughout the USA who specialize in tinnitus who want to help their patients. We’re taking an intentional approach to onboarding new providers who want to add Lenire to their practice to ensure that we can give them the knowledge and resources they need to get the best possible clinical outcomes for their patients.”, said Eric Timm, President of Global Commercial Operations at Neuromod Devices.
Lenire was granted a US FDA De Novo in March 2023 as the first device of its kind approved for the treatment of tinnitus in the USA following the success of a third large-scale clinical trial1. The trial included 112 participants and found Lenire provided significantly superior clinical outcomes than sound therapy alone for patients with moderate, severe and catastrophic tinnitus2.
Neuromod plans to onboard 150 providers in the USA by the end of 2024 in order to meet the significant demand for Lenire from tinnitus patients as well as from hundreds of healthcare professionals interested in providing treatment with Lenire in their practices.
“The patient successes from the first Lenire providers we trained in 2023 have been an inspiration. We’re committed to providing the same level of training and ongoing clinical support to every healthcare professional we onboard so they can treat their patients as effectively as possible with Lenire. It’s wonderful to have more committed tinnitus specialists making Lenire available to tinnitus patients in the coming weeks and I’m looking forward to working closely with more providers in 2024 and beyond as we make Lenire available to many more people living with tinnitus”, commented Dr. Tish Ramirez, Chief Commercial Officer at Neuromod USA Inc., a US-based subsidiary of Neuromod Devices.
Neuromod Devices continues to expand the availability of Lenire in the US and Europe. Earlier this year, Neuromod reached an agreement with Cilia Biotech to distribute Lenire in Italy, bringing the number of European countries Lenire is available in to 15. The first tinnitus patients in Italy started treatment with Lenire in August 2023.
References
- https://www.accessdata.fda.gov/cdrh_docs/pdf21/DEN210033.pdf
- https://classic.clinicaltrials.gov/ct2/show/NCT05227365
About Neuromod Devices
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of bimodal neuromodulation technologies to address the clinical needs of patients suffering from chronic and debilitating tinnitus. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe and has received a granting of De Novo approval from the FDA in the USA. For more information visit neuromoddevices.com.
About Lenire
Lenire is a combined acoustic and electrical intraoral stimulation device for the relief of tinnitus. The device’s novel bimodal neuromodulation technology includes three parts. Bluetooth® headphones, which play custom sounds to the ear to activate the auditory nerve, a Tonguetip®, which is a proprietary intraoral device that also activates nerves by sending mild electrical stimulation to the surface of the tongue, and a controller that allows patients to adjust the duration and treatment intensity.
The custom sounds and tongue stimulation work together to reduce patients’ tinnitus severity. It is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to relieve tinnitus in three large-scale clinical trials.
Lenire has been granted De Novo approval for the treatment of tinnitus in the USA by the FDA and CE-mark certification in Europe. Further details about Lenire including a list of providers can be found at lenire.com.
Connect with Neuromod Devices
LinkedIn: linkedin.com/company/neuromod
Twitter: twitter.com/NeuromodDevices
Website: neuromoddevices.com
