TinniMizer : A Patient-specific Novel Approach for Tinnitus Treatment

Periodic Reporting for period 1 - TinniMizer (TinniMizer : A Patient-specific Novel Approach for Tinnitus Treatment)

Période du rapport: 2018-12-01 au 2019-03-31

Tinnitus – described as a spontaneous reaction of the nervous system and as "a perception of noise or ringing in the ears" – Is one of the symptoms of hearing loss. Tinnitus is the third most common problem prevalent among the global populace and can be a dilapidating condition with severe Tinnitus resulting in hearing loss. According to the American Academy of Audiology, in 2016, global prevalence for Tinnitus varied from 5% to 42% according to different studies. Apart from the functional, social and emotional impact of hearing loss, Tinnitus has adverse economic impacts globally. It is estimated that unaddressed hearing loss poses an annual global cost of ~€709 Billion. This includes health sector costs (excluding the cost of hearing devices), costs of educational support, loss of productivity, and societal costs.
Fighting Tinnitus is often a challenging, time-consuming, and exhausting process due to the following reasons:
• It is difficult to determine severity of Tinnitus and characterize it in standard terms, as each individual experiences his/her own form/type of Tinnitus.
• Tinnitus can accompany many different diseases, but usually its cause cannot be found exactly.
• There is no standardized (well-established) approach for its treatment.

The overall objective of the TinniMizer project seeks to develop and commercialise a new, patient-specific, state-of-the-art, and patented musical therapy system called TinniMizer as a new treatment for Tinnitus. Preliminary results showed that the TinniMizer therapy is 70% effective in the treatment of Tinnitus with the industry standard being 35%. The TinniMizer solution is easy to understand, easy to use and cost effective. Furthermore, patients and medical practitioners can monitor patient progress securely, online. The Phase 1 project sought to assess the technical, commercial and financial feasibility of the project. We have thus undertaken a 4-month feasibility study on these three aspects of the TinniMizer therapy. The objectives of this study were to:
• Determine the viability and complete optimisation criteria for TinniMizer
• To determine and quantify our target market regionally and globally to influence exploitation strategies and business strategies
• To execute a detailed risk assessment and critical path analysis for project execution
This feasibility study has enabled us to devise a developmental blueprint for the development and commercialization of the TinniMizer solution. We have also developed a business plan o guide the successful introduction of TinniMizer to the market.

We have undertaken an all-encompassing Feasibility study. The results of the Feasibility Study have enabled us to analyze the opportunities available and barriers to be mitigated for the successful development and commercialization of the TinniMizer solution. These tasks were divided into three different segments, namely, Technological, Market and Commercial and Financial Feasibility.

Technical Feasibility- We assessed the technical viability of the system by assessing the capacity of the system to process different audio signals. We also ran the software on a secure cloud system. A clinical trials plan for the system was devised and the system was optimized. Finally, we created a blueprint for an app version of the technology.

Commercial Feasibility – We assessed the global Tinnitus Management market, reviewing trends, growth drivers, segmentation, major players and competing solutions within the market. We also conducted a partner search for development and exploitation partners to create a plausible route to market. A regulatory framework and certification analysis was done to determine the regulatory requirements before market launch, as well as a comprehensive freedom to operate analysis to ensure that we do not infringe upon an third party rights and have leave to commercialize our solution. We also conducted a commercial risk analysis to assess the impact our technology will have on the market and to our company. The results of these activities influenced the development of an exploitation and dissemination strategy for the commercialization of the TinniMizer solution.

Financial Feasibility – Using information from the technical and commercial feasibility analysis, we were able to complete a financial feasibility, thus devising a sound business model for the solution. This enabled us to make sales forecasts for TinniMizer and assess the impact of the solution on the market and to our growth initiatives. Finally, we conducted a financial risk assessment to identify and mitigate the impact of these risks on our business.

This Feasibility Shas confirmed the viability, effectiveness, attractiveness and potential cost of TinniMizer as well as a plan for further development before market launch. We have also confirmed the potential market for our solution globally and the best markets for market launch and commercial exploitation. Commercialization partners have been identified enabling us to devise the best route to market. We have confirmed the potential to grow our business through TinniMizer as the commercialization of the solution will result in increased turnover and lucrative profits financing business growth and employment. We will look at the results of this project with proprietary information kept confidential for exploitation during the next phase of the project. Non-proprietary information will be shared with the general public via the company website, the EC website, social media channels and through white papers.

State of the art solutions have proved ineffective (only 35% effective), expensive and have a long duration. Furthermore, patients and medical personeel are unable to track treatment progress. They have not been able to cure Tinnitus, resulting in extreme discomfort or permanent hearing loss for many Tinnitus patients. TinniMizer has shown a 70% improvement in Tinnitus systems over a short period of 6 months, with the potential to completely cure Tinnitus. At the end of the project, we expect to have developed a fully functional, validated and low-cost TinniMizer therapy ready for market launch. We also have to have developed a route to market with first customers lined up to use our solution. The socio-economic and wider social implications of the project will be:

• An increased quality of life for patients with the Tinnitus condition.
• Reduced adverse functional, social and emotional impact of hearing loss for the vulnerable members of society, that is, the elderly and children. 5.3% of the world’s population – approximately 360 million people – are reported to have disabling hearing loss. 91% of these are adults with the remaining 9% being children under the age of 15 years.
• Reduced economic burden as Tinnitus patients will no longer present a heavy burden on the economy. Tinnitus has adverse economic impacts globally and it is estimated that unaddressed hearing loss poses an annual global cost of ~€709 Billion. The cost to Europe of all grades of hearing losses is approximately €284 Billion.
• The project will create employment. We envisage hiring 50 people in the first five years after market launch.

TinniMizer Therapy

Periodic Reporting for period 1 - TinniMizer (TinniMizer : A Patient-specific Novel Approach for Tinnitus Treatment)

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