Neuromod Devices uniquely leverages its sophisticated technology to meet tinnitus patients’ dynamic needs and strict global regulatory requirements for medical devices.
SAN ANTONIO, Oct. 19, 2023 /PRNewswire/ — Frost & Sullivan recently researched the neuromodulation devices for tinnitus space and, based on its findings, recognizes Neuromod Devices (Neuromod) with the 2023 North American New Product Innovation Award. Neuromod is a medical technology company focused on designing and developing bimodal neuromodulation solutions that address the growing clinical needs of patients with tinnitus.
Neuromod has delivered a groundbreaking medical device and services that support healthcare professionals to achieve exceptional clinical outcomes for their tinnitus patients. The company’s flagship product, the Lenire® device for tinnitus treatment, boosted Neuromod’s market leadership further and clearly differentiated the company because of its superior design, unmatched reliability, and first-class quality. Lenire® combines acoustic and electrical intraoral stimulation by leveraging a top-quality Bluetooth headset to play customized sounds and a Tonguetip®, a patented intraoral device that activates nerves through light electrical tongue stimulation.
This leading-edge medical device has proven its ability to enhance tinnitus patients’ well-being and overall quality of life. Neuromod conducted numerous clinical trials to validate Lenire®‘s effectiveness, gathering comprehensive clinical evidence of its efficacy in internationally recognized centers. For example, the US Food and Drug Administration (FDA) approved Lenire® as the first device of its kind for the treatment of tinnitus based on its strong results in a pivotal 112-patient TENT-A3 controlled clinical trial and confirmatory real-world evidence (RWE) from 204 patients.3
“The majority of TENT-A3 participants with moderate or worse tinnitus had significant relief using Lenire when audio-only had no meaningful impact. Lenire® was more effective overall than sound therapy, one of the current clinical treatment standards,” said Manuel Albornoz, best practices research analyst at Frost & Sullivan.
The results of Lenire’s second large-scale clinical trial, TENT-A2, were published in the highly regarded scientific journal Nature – Scientific Reports. The findings of this 192-patient double-blind randomized trial showed that changing stimuli midway through treatment enhanced the effectiveness of bimodal neuromodulation.
“After the treatment ended, 91% of trial participants who used Lenire® as directed reported a sustained reduction in symptoms for at least 12 months. Furthermore, 95% of TENT-A2 trial participants sensed improved tinnitus symptom severity after 12 weeks of treatment,” 2 continued Albornoz.
The company has built an outstanding reputation by closely collaborating with patients to develop cutting-edge treatments for underserved chronic diseases. For this reason, its FDA approval and clinical trial results increased US demand for Lenire®, consolidating Neuromod’s position as a world leader in tinnitus treatment.
Additionally, researchers found that Neuromod’s bimodal neuromodulation technology leads to more effective positive neuroplasticity than single-input stimulation. This fuels Lenire®‘s relevance in the market and sets Neuromod Devices apart as it is key to alleviating tinnitus symptoms.
“For instance, in TENT-A3, 79.4% of patients experienced a clinically significant improvement, 82.4% were compliant with the bimodal treatment, and 88.6% would recommend Lenire® 3 to other tinnitus patients. As well as effectiveness, Lenire was also proven to be inherently safe, as zero serious adverse side effects related to treatment with Lenire were found across all clinical trials.1,2,3 Neuromod successfully replicated these results with real-world patients in Europe,” noted Ashish Kaul, industry analyst at Frost & Sullivan.
Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features/benefits of the product and the increased return on investment (ROI) it gives customers, which, in turn, raises customer acquisition and overall market penetration potential.
Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.
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About Neuromod Devices Ltd
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 www.neuromoddevices.com.
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 www.lenire.com.
Connect with Neuromod Devices Ltd
- 1. TENT-A1 Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
- 2. TENT-A2: Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
- 3. TENT-A3: Clinical trial data in preparation for independent publication: clinicaltrials.gov/ct2/show/NCT05227365.
- Note 1: All statistics based on compliant patients. Patient compliance criteria is detailed in Lenire’s clinical trial design.
- Note 2: TENT-A1/TENT-A2 were not considered by the United States of America FDA as part of Lenire’s FDA Grant and, as such, applies solely to outside the US. TENT-A3 and RWE were considered.