Coverage examples: Every week we take a look at some of the stories sent through MediaHQ’s press release distribution tool and post some of the best covered ones in a weekly blog. For this week, Neuromod Devices and Bord Bia made it to the top of our list.
1) Neuromod Devices
Title: FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
Author: Joe Roche
Email delivery rate: 100%
Time of release: 10:28 on the 7th March
FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
- Neuromod Devices’ non-invasive device, Lenire, is the first of its kind granted approval to treat tinnitus in the US market.
- At least 25,000,000 Americans are suffering from tinnitus, 2,700,000 are veterans.
- FDA approval based on results of 112-patient pivotal TENT-A3 clinical trial supported by confirmatory Real-World Evidence from 204 patients.
- TENT-A3 primary endpoint analysis showed that patients at least moderately impacted by tinnitus1 achieved a clinically meaningful improvement following the bimodal phase of the trial. This was consistent with what was observed in the Real-World Evidence submitted to the FDA.
- Over the entire trial, 79.4% of patients experienced a clinically significant improvement. 82.4% were compliant to bimodal treatment and 88.6% would recommend Lenire as a tinnitus treatment.
- When compared to sound therapy alone, patients at least moderately impacted by tinnitus1 were significantly more likely to achieve a clinically meaningful improvement using Lenire’s bimodal stimulation.
- Treatment with Lenire to be available for Americans with tinnitus from April 2023.
Chicago, Illinois, 7th March 2023: Neuromod Devices Ltd. announced today that the US Food and Drug Administration (FDA) has granted De Novo approval to Lenire, the first bimodal neuromodulation device of its kind to be approved by the FDA for the treatment of tinnitus.
Tinnitus, which is commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans2 are currently suffering from tinnitus.
Tinnitus is a silent burden on the USA’s national healthcare system, costing an estimated $660 per patient per year for visits to clinics alone3. Tinnitus is also the most prevalent and fastest-growing service-connected disability compensated for by The US Veterans Administration (VA), with more than 2.7 million veterans compensated in 20224 and 12% year-on-year growth5. It is estimated that the VA paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 20226, with further undisclosed expenditure on treatments, such as hearing aids, sound therapy and counselling, which deliver varying levels of success.
“Lenire’s approval not only means that millions of Americans living with tinnitus can get the treatment they need but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients. Lenire is the first bimodal neuromodulation device to go through the rigors of the FDA’s De Novo process. For patients that are at least moderately impacted by their tinnitus1, Lenire has now been shown to be more effective than sound therapy, which is one of the current clinical standards of treatment.” said Ross O’Neill, Neuromod Devices’ Founding CEO.
The FDA’s De Novo approval is based on the success of Lenire’s third large-scale clinical trial, TENT-A3, supported by Real-World Evidence from 204 patients. Over the entire trial, 79.4% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment7. The TENT-A3 primary endpoint analysis showed that patients that were at least moderately bothered by tinnitus, which includes patients in the moderate, severe and catastrophic categories as defined by the Tinnitus Handicap Inventory (THI)1, achieved a clinically meaningful improvement in tinnitus following the bimodal treatment phase of the trial. The analysis showed that this patient group were more likely to achieve a clinically meaningful improvement using Lenire’s bimodal sound and tongue stimulation than sound therapy alone7. TENT-A3 also demonstrated that Lenire is inherently safe with zero serious adverse events7. These efficacy, compliance and safety findings were highly consistent with the Real-World Evidence from 204 patients included in the De Novo submission.
TENT-A3 was a controlled clinical trial, designed by Neuromod to meet the FDA’s requirements, that compared the effects of 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone. The trial was conducted at three independent sites from March to October 2022 with 112 enrolled participants8. The De Novo approval of Lenire is significant as it acknowledges Lenire as a technological and clinical pioneer for tinnitus treatment. This approval establishes a new regulatory category for medical devices in the USA.
"With this FDA approval of the Lenire device, it will provide me and tinnitus specialists across the United States with an exciting new tinnitus treatment option for our clinical toolbox,” explained Dr. Jason Leyendecker (AuD). "Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied. What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time.” Dr. Leyendecker is a leading tinnitus specialist and owner of The Tinnitus and Hyperacusis Clinic of Minnesota. He is the past President of Minnesota Academy of Audiology and President Elect of Academy of Doctors of Audiology.
The TENT-A3 trial builds upon the success of two previous landmark clinical trials that included more than 500 patients. TENT-A1 was one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field. The study was the cover story for the prestigious scientific journal Science – Translational Medicine in October 2020. TENT-A1 was a double-blind randomized trial involving 326 patients who were evaluated over a 12-week treatment period and a 12-month post-treatment phase9. 86.2% of those who completed the 12 weeks of treatment reported improvement in their tinnitus severity9. These therapeutic improvements continued for 12 months after cessation of treatment. 83.7% of patients were treatment compliant and there were zero serious adverse events in the trial9.
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. 95% of patients that completed 12 weeks of treatment reported improvement in their tinnitus severity10. These therapeutic effects were sustained up to 12 months after treatment ended9. 83.8% of patients were treatment compliant and there were zero serious adverse events in the trial10.
“What is most remarkable is the consistency of the efficacy, safety and compliance data across our TENT-A1, TENT-A2 and TENT-A3 clinical trials. Taken together, we have demonstrated the effectiveness and inherent safety of Lenire in over 600 clinical trial patients. De Novo approval from the FDA is another significant achievement in what has been an exciting journey for our bimodal stimulation technology,” said Prof. Hubert Lim, Chief Scientific Officer at Neuromod Devices.
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.
“FDA approval of the Lenire Tinnitus Treatment System is a quantum leap forward in the caring of patients with bothersome tinnitus. The otolaryngologist now has access to innovative Lenire technology and can prescribe it to patients who are at least moderately impacted by their tinnitus. The majority of these tinnitus patients are either inadequately relieved or are opting not to pursue existing options, such as hearing aids. These patients can now move forward with this impressive treatment system.” expressed Dr. Steven W. Cheung, who is a Professor of Otolaryngology-Head and Neck Surgery at the University of California, San Francisco, and Staff Otorhinolaryngologist at the Veterans Affairs San Francisco Healthcare System.
Neuromod Devices was founded by Dr. Ross O’Neill in 2010 to develop bimodal neuromodulation technologies for tinnitus and is supported by venture capital firms Fountain Healthcare Partners and Panakes Partners. In 2021, Neuromod established Neuromod USA Inc. as a wholly owned subsidiary to prepare for the market entry of Lenire in the USA pending FDA approval. Since then, Neuromod USA has convened a clinical advisory board of specialist tinnitus clinicians from across the US. These clinical experts will advise on and ensure that patients who will use Lenire receive unrivalled care throughout their treatment.
Following the FDA’s granting of approval, Neuromod will train Audiologists and ENT Surgeons specialising in tinnitus care with the intention of treating the first tinnitus patients based in the USA as soon as April 2023.
References & Notes
- As measured by Tinnitus Handicap Inventory (THI). THI is the most widely used clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. The THI is a validated instrument that is measured on a scale of 100, the higher the score, the greater the impact of tinnitus. THI scores are categorized into five severity levels: slight, mild, moderate, severe and catastrophic. Patients that are at least moderately affected by their tinnitus have a THI score of 38 and above and fall into the moderate, severe and catastrophic categories.
- Goldstein E., Ho C.X., Hanna R., Elinger C., Yaremchuk K.L., Seidman M.D., Jesse M.T. Cost of care for subjective tinnitus in relation to patient satisfaction. Otolaryngol. Head Neck Surg. 2015;152:518–523. doi: 10.1177/0194599814566179.
- US VA Benefits Report Fiscal Year 2022: https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf
- Calculated based on average annual increase in tinnitus benefit recipients from 2008 to 2022: https://www.benefits.va.gov/REPORTS/abr/archive.asp
- According to https://www.va.gov/disability/compensation-rates/veteran-rates/past-rates-2022/ the 2022 10% disability rate was $152.64 per month. 2,703,665 veterans (https://www.benefits.va.gov/REPORTS/abr/docs/2022-abr.pdf) receiving 12 payments of $152.64 for tinnitus results in $4.952 billion. The VA assigns a 10% disability rating to tinnitus: https://www.benefits.com/veterans-disability/tinnitus-most-common-va-disability
- TENT-A3 clinical trial data in preparation for publication
- Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
- Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
For More Information
Head of Communications,
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
- LinkedIn: linkedin.com/company/neuromod
- Twitter: twitter.com/NeuromodDevices
- Website: neuromoddevices.com
2) Bord Bia
Title: PRESS RELEASE: Bord Bia’s global programme of events for St Patrick’s Day in 18 countries
Author: Michelle Jordan
Email delivery rate: 95%
Time of release: 08:00 on the 14th of March
Bord Bia’s global programme of events for St Patrick’s Day in 18 countries
Dublin, March 14th - As St Patrick’s Day approaches, Bord Bia is preparing to bring Irish food and drink to an international audience with a series of promotional activities across 18 countries.
From Lagos to London, through its network of international offices, Bord Bia has scheduled events aimed at growing business in established markets and creating awareness of Ireland’s food and drink offering in emerging markets. The St Patrick’s themed global programme will include events for consumers, retailers, trade and foodservice operators to highlight the range, quality and supply capability of Irish food and drink.
Launching this year’s programme of activity, Bord Bia CEO Jim O’Toole said: “St. Patrick's Day is a globally renowned festival and provides the industry with a wonderful opportunity to maximise the excellent reputation of Irish food, drink and horticulture and to showcase Origin Green - Ireland's national food and drink sustainability programme - abroad. Through opportunities with existing and new customers Bord Bia will engage in senior level trade meetings, online campaigns, retail and restaurant promotions, in-store tastings, cookery demonstrations, media briefings, and on-the-ground Irish food festivals, all with an aim of increasing the global footprint of Ireland’s food and drink industry.”
Planned promotional events
UK - The UK continues to be Ireland’s principal export destination, with exports valued at an estimated €5.4 billion in 2022. Bord Bia is engaging with an extensive national publicity programme in the UK to promote Irish beef, drink and speciality foods. Irish produce will be showcased to over 30,000 people at the Lord Mayor of London’s official St. Patrick’s Day consumer event at Trafalgar Square. This is a public event with over 30,000 people in attendance annually.
The annual Meet the Makers drink trade event sees 16 Irish spirits, cream liqueur and craft beer producers showcase the best of Irish drinks to 70+ buyers and other key industry influencers. In China, where online retail sales exceed $1 trillion each year, Bord Bia’s team in Shanghai is partnering with high-end imported supermarket CitySuper to promote Irish cheese, butter, and whiskey, with a weeklong promotion covering e-commerce and four physical stores in Shanghai.
Europe - During the month of March, Bord Bia’s Irish beef and seafood promotions will target millions of consumers in Europe via well-known grocery retailers in France, Germany, Italy, Luxembourg, the Nordics, Spain across more than 1,400 stores.
On March 17th, Bord Bia CEO, Jim O’Toole, will welcome Minister of State for Trade Promotion, Digital and Company Regulation, Dara Calleary T.D. at a trade event in France hosted by the CEO of Carrefour France, Rami Baitiéh, connecting 15 Irish food and drink suppliers with 17 members of Carrefour’s senior management and purchasing team.
Jim O’Toole added: “Carrefour is the second largest retailer in France and a global player with whom we plan to develop further partnership on areas of common strategic alignment, including sustainability. This is important as we know from Bord Bia’s recent Global Sustainability Insight research that almost half of French consumers believe that more sustainably produced products are essential to their grocery choices.”
In Italy, Bord Bia is doing a takeover of public transport with Quality Assured beef advertising campaigns, tailored to St Patrick’s Day, displayed across trams in Milan.
Bord Bia in the Netherlands is running a new Cook Like an Irishman consumer campaign across digital platforms, showing how accessible and enjoyable cooking with Irish beef can be.
Southeast Asia –In Singapore, Bord Bia is organising two Irish beef butchery demonstrations for St. Patrick’s Day for foodservice customers from 5-star hotels and Michelin-starred restaurants. Bord Bia’s co-funded EU campaigns are also running across Malaysia, Philippines and Japan under the banner, “Sustainable European Dairy from Ireland”.
In South Korea, Minister of State with responsibility for Research and Development, Farm Safety, and New Market Development, Martin Heydon T.D., will visit Seoul to chair Bord Bia’s Meat Sector Roundtable discussion with high potential beef and pork customers.
Trade show activity
In Japan, Bord Bia represented Ireland at the FoodEx 2022 trade show in Tokyo which is the busiest trade show of the year in Japan and is expected to deliver opportunities for Bord Bia clients across the priority sectors of meat, dairy, seafood and beverages. In the US, Bord Bia had an information stand at the Annual Meat Conference in Dallas, Texas as part of Bord Bia’s EU co-funded beef and lamb campaign in the US, launched in January.
And finally, Bord Bia is hosting Irish food and drink companies in Germany this month at the Internorga trade fair for the hospitality and restaurant Industry in Hamberg from March 10th -14th March, and at Prowein, one of the world’s leading wine and spirits trade show, in Düsseldorf from March 19th – 21st. Both trade shows will attract in excess of 100,000 visitors.
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