Non-invasive neuromodulation technology developer Neuromod Devices announced today that it is appointing Florian Elsaesser as its new chief commercial officer. Elsaesser is a year veteran in the space, having worked extensively in the hearing aid industry, according to a news release. Currently, the company is working toward commercializing Lenire in Europe as it also seeks to take the regulatory steps to bring the device to market in the U.Dynamics 365 finance and operations development tutorial
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Leave a Reply Cancel reply You must be logged in to post a comment.Discussion in ' Treatments ' started by Tinnitus TalkJul 20, Search titles only Posted by Member: Separate names with a comma.
Newer Than: Search this thread only Search this forum only Search child forums as well Display results as threads. Useful Searches. Tinnitus Talk. What Is Lenire? Lenire is a newly launched treatment for tinnitus, which is claimed to reduce ringing in the ears.
Lenire was brought to market by Irish medical device company Neuromod, after having conducted several clinical trials to assess its safety and efficacy. Post Your Experiences! Lenire users are invited to post here about their experiences during and after completing the treatment programme. We do encourage users to share their experiences so that others may learn from it!
You may report on for instance: the device itself; how easy or difficult it is to use; whether you experienced any immediate or long-term effects from it; and your experience as a Neuromod customer.
To keep this thread easy to read and follow, anyone who is not currently a Lenire user is kindly asked to refrain from posting here or moderators will remove your post. We may ask anyone posting here to provide us with evidence that they are indeed Lenire users.
In doing so, your identity will not be publicly revealed. Reliability of Information Please note that the experiences reported here are entirely personal and anecdotal. We are publishing this for informational purposes only, not as any kind of structured treatment review. Beware that one or two user experiences are not necessarily representative of the average user experience.
This entails periodically filling in a simple survey, allowing us to collect some more structured information on your experience. Your anonymity will be protected. Winner x 13 Like x 5 Agree x 3 Optimistic x 1. Tinnitus TalkJul 20, Location: Lisburn, N.1st gen crv mods
This will be my first blog post, I plan to do so something similar at each notable stage of the journey. All my comments are mine alone, I have no affiliation with Neuromod; some are facts, some are speculation I'll denote any speculation for clarity.
Some quick context; I've had very mild fleeting tinnitus as long as I can remember, but it would always go away after a few hours.
In February and March I developed a feeling of pressure in my sinuses and headaches that lasted a few weeks. When the symptoms went away 10th March I had more permanent tinnitus that is still there today. I also experienced a loud screech whilst on the London underground on the 5th March, this is notable because I remember my ears hurt afterward, probably not a good sign.
I will not mention Neuromod staff names or personal details, or details of other patients that I met at any of my appointments unless they want to share their details themselves. No one asked me to keep any of this private, I just don't feel it's appropriate or relevant.Device aims to stop the ringing in your ears
There's a window and a Nest Doorbell, with a sign that says to press here and someone will be with you soon.Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in various executive positions for Sivantos and Siemens Audiology. After the acquisition, Elsaesser went on to hold senior business development and marketing roles in the newly rebranded Sivantos.
In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions. The Company reports it is working towards the European commercialization of Lenire, scaling up manufacturing capacity to meet anticipated European demand, and progressing US regulatory strategy to secure market entry into the United States.
Elsaesser will play a key role in these developments. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology.
It is a pivotal time for the Company as we progress with European commercialization of Lenire. Lenire has achieved compelling results in multiple, large-scale clinical trials. Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss.
These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Therefore I see huge opportunities for Lenire to boost the hearing aid retail market. Your email address will not be published. Related Posts. Leave a reply Cancel reply Your email address will not be published. Follow Us Facebook.Tinnitus is the perception of sound in the absence of a corresponding external acoustic stimulus.
Bimodal neuromodulation is emerging as a promising treatment for this condition. The main objectives of this study are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli for a proprietary bimodal auditory and somatosensory neuromodulation device, as well as to explore whether specific subtypes of patients are differentially responsive to this novel intervention for reducing the symptoms of chronic tinnitus.
This is a two-site, randomised, triple-blind, exploratory study of a proprietary neuromodulation device with a pre—post and month follow-up design.
Find the Right Clinic:
Three different bimodal stimulation parameter sets will be examined. The study will enrol patients, split between two sites Dublin, Ireland and Regensburg, Germanyto complete 12 weeks of treatment with the device. The main indicators of relative clinical efficacy for the three different parameter sets are two patient-reported outcomes measures, the Tinnitus Handicap Inventory and the Tinnitus Functional Index, after 12 weeks of intervention.
Clinical efficacy will be further explored in a series of patient subtypes, split by the stratification variables and by presence of a somatic tinnitus. Evidence for sustained effects on the psychological and functional impact of tinnitus will be followed up for 12 months.Dyno for sale
Safety data will be collected and reported. Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences. The trial is registered on ClinicalTrials. The main strength of this study is that it is a large two-site, triple-blinded, randomised trial that will provide exploratory evidence of the relevance of stimulation parameters on the clinical efficacy of different bimodal stimulation parameters and will inform future trial design.
The study comprehensively characterises patients for subtyping and this will refine candidature for the intervention.
Among the limitations of this study are the variability in duration between screening and enrolment and the selection of the investigated stimulation parameters. Tinnitus often coincides with hearing loss and it is commonly believed that hearing loss may be a contributory factor. Tinnitus has traditionally been treated by means of acoustic stimulation with limited success.Nys vapor tax
One approach that has been increasingly investigated in the last decade is invasive and non-invasive neuromodulation of brain structures and networks involved in tinnitus generation. Neuromodulation approaches of the central nervous system for the treatment of tinnitus include repetitive transcranial magnetic stimulation, transcranial direct current stimulation and epidural stimulation of temporal, temporoparietal and frontal brain areas. All of these approaches have resulted in reduction of tinnitus handicap in a subgroup of patients.
To date, a limited number of uncontrolled pilot studies have been conducted to assess the safety and initial efficacy of neuromodulation employing cranial nerve stimulation for tinnitus. These have included invasive vagus nerve stimulation VNS14 non-invasive stimulation of the vagus nerve 15 16 and non-invasive cervico-trigeminal nerve stimulation CTNS.
The intervention evaluated by Hamilton and colleagues 12 used synchronised auditory and somatosensory stimulation. However, recent animal research suggests that interstimulus timing intervals may play an important part in the effectiveness of bimodal auditory and somatosensory stimulation on tinnitus.
This study protocol represents the first important step towards that goal. The main objectives of the study described here are to investigate the relevance of interstimulus timing and the choices of acoustic and tongue stimuli in order to optimise bimodal neuromodulation parameters for this treatment.
Exploratory analyses will be conducted to investigate whether subtypes of patients are differentially responsive to this novel intervention. Safety data will also be collected and reported. Additional feasibility outcomes concern methodological and procedural uncertainties when this novel medical device is prescribed and fitted in a large sample of patients.
The Treatment Evaluation of Neuromodulation for Tinnitus TENT-A study is a two-site, randomised, triple-blind, exploratory study examining three different bimodal stimulation parameter sets.
The trial sponsor is Neuromod Devices Limited. The trial was registered on ClinicalTrials. The first patient was consented in 22 March with the last visit planned for May Potential patients will be excluded if they have pulsatile tinnitus rhythmical sounds that often beat in time with the heartbeattinnitus caused by head or neck injury, or tinnitus resulting from any other neurological condition. A final set of exclusion criteria based on medical history taken at the screening assessment are: oral piercings, pregnancy, involvement in medicolegal cases, history of auditory hallucinations, any current neurological conditions that may lead to loss of consciousness eg, epilepsycurrent prescription of any drug for a central nervous system pathology and previous use of bimodal neuromodulation devices.
Finally, the patient may be excluded if the principal investigator does not deem the candidate to be suitable for the study for other reasons not listed above. Auditory stimulation is delivered through high-fidelity circumaural headphones and comprises a mixture of a wideband noise and sequences of pure tones.
Stimulation of the somatosensory system is delivered electrically using an array of 32 transmucosal electrodes on the tongue. The somatosensory stimulator is arranged so that there is a mapping between the electrodes in the array and frequencies in the tone sequence. The stimuli for each parameter set across the three arms are outlined in table 1.The company noted that the funds secured comprised of equity investment and venture debt, with the financing round led by existing investors including Fountain Healthcare Partners and Moffett Investment Holdings with Kreos Capital and Silicon Valley Bank providing the venture debt.
Neuromod intends to use the funds to hasten the commercialization of its Lenire tinnitus treatment device in Europe, scaling up manufacturing capacity to meet anticipated levels of demand across the continent.
A second prong of the strategy will be to step up efforts to secure the regulatory requirements in order to market the product in the US, as well as Europe.
More info. There are many possible causes and types of tinnitus, which makes finding a cure for tinnitus difficult. The Tinnitus Experience The experience of tinnitus varies greatly from person to person; what it sounds like, how unpleasant it can be and how much tinnitus intrudes on daily life. Few Options Until Now It is often said that there is no cure for tinnitus, but that does not mean that there is nothing that can be done.
A proprietary intra-oral device, ergonomically designed to sit comfortably in the closed mouth. Mild and safe energy pulses are delivered to the surface of the tip of the tongue to activate touch nerves mainly the trigeminal nerve. The activated nerves convert the sound and the energy pulses into signals that are relayed to the brain, where over time the unique signal patterns work to reduce and soothe the perceived tinnitus experience.
More info Got It! Coming Soon. Deutsch Download User Manual.
Lenire — Bimodal Stimulation Treatment by Neuromod
Breakthrough evidence-based tinnitus treatment from Neuromod, harnessing the science of neuromodulation Find a Clinic. The Challenge. The Controller A lightweight, handheld device that controls the time and intensity of the treatment.Florian Elsaesser has been appointed as Chief Commercial Officer. Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in various executive positions for Sivantos and Siemens Audiology.
After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions.
Elsaesser's appointment follows the completion of two of the largest and longest followed up clinical trials ever conducted in tinnitus, including participants. Elsaesser will play a key role in these developments.
Welcoming the appointment, Dr. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology.
Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss. These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Centre of Excellence in Tinnitus Care and Neuromodulation.
This investment marks a significant milestone for Neuromod as the Company recently opened its first Centre of Excellence specialising in neuromodulation and tinnitus at the Hermitage Medical Clinic in Dublin. Additional locations throughout Europe have been identified and will become operational during the course of We are excited to be working with them to fund their expansion across Europe and the United States.
Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating tinnitus.
The company was founded inby Dr. Neuromod has conducted the largest and longest followed-up clinical trials in tinnitus to confirm the efficacy of its non-invasive neuromodulation treatment device for this extremely common disorder for which no standard of care has yet been established.
Deborah and Suzanne bring more than 45 years of combined experience in medical device regulatory and quality matters.
Neuromod Closes on $8.75 Million Funding Round
I am delighted that industry leaders of the calibre of Deb, Suzanne and Cathal have agreed to join our team. Neuromod is investing in growing our organisation; we have been working tirelessly to ensure that all systems are in place to bring our much-anticipated breakthrough treatment to the large population of people living with tinnitus globally.
Neuromod has conducted extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation treatment for this extremely common disorder for which no standard of care has yet been established. A clinical expert in tinnitus and audiology, Professor Tyler is a renowned pioneer in the advancement of tinnitus research and treatment, founding the annual International Conference on Management of Tinnitus and Hyperacusis more than 26 years ago.
In June, Mr. Christopher M. Smith, a global leader in the hearing and medical device industries agreed to join the Board of Directors and in January, Professor Hubert Lim, a world-renowned scientist and thought leader in auditory neuroscience was appointed as Chief Scientific Officer. Commenting on the appointment, Dr. Tyler is a world-renowned audiologist who has advanced our understanding of tinnitus and pioneered research into the development of treatments for tinnitus throughout his illustrious career.
As a practising audiologist who continues to see and help a large number of tinnitus patients, Prof. Many of these patients cannot sleep at night and take medications for anxiety and depression.
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