KTC Selected for R&D on Digital Therapeutic Device Platform for Hearing and Tinnitus...Commercialization Expected
Joint Project with Four Organizations, Including NewLive Co., Ltd., with a Total Investment of 7.3 Billion KRW by End of December 2028
Projection for Commercialization of Personalized Devices Integrating Digital Therapeutics and Electroceuticals; "World's First"
▲ KTC Cybersecurity Testing of Medical Devices
The Korea Testing and Research Institute for Electric and Electronic Equipment (KTC, President: Sungil Ahn) announced on the 7th that it has been selected as the research institution for the project "Development and Commercialization of Personalized Digital Therapeutic Device Platform for Improvement of Hearing Loss and Tinnitus Symptoms" by the Korea Institute for Advancement of Technology (KIAT).
The project, which will run until the end of December 2028 with a total budget of 7.3 billion KRW over 4 years and 9 months, is being carried out jointly with the digital therapeutics specialist company NewLive Co., Ltd., the Catholic University Industry-Academic Cooperation Foundation, the Yonsei University Industry-Academic Cooperation Foundation, and the Korea Electrotechnology Research Institute.
The research includes:
Verification of the Digital Therapeutic Device Platform
Application for Innovative Medical Device and Product Approval
Licensing Tests and Technical Document Preparation for Overseas Exports
According to the Health Insurance Review and Assessment Service, the prevalence of tinnitus in Korea is 20% of the total population, with 300,000 people visiting medical institutions annually.
Moreover, the number of hearing-impaired patients (as per the Health Insurance Review and Assessment Service) increased by 23% from 84,049 in 2018 to 103,474 in 2022, with the number of patients in their 20s rising by over 40% from 8,240 to 11,557 during the same period.
NewLive Co., Ltd. is set to receive product approval from the Ministry of Food and Drug Safety (MFDS) this year for its independently developed digital therapeutic devices and electroceuticals for tinnitus treatment, reflecting domestic medical conditions.
Through this project, KTC will derive evaluation items according to MFDS cybersecurity requirements for NewLive's IoT products and issue performance test certification for the combined personal stimulator and cognitive therapy software.
KTC anticipates that upon completion of the project, it will be possible to commercialize the world's first personalized tinnitus treatment platform medical device that integrates digital therapeutics and electroceuticals.
Furthermore, the project is expected to enable remote treatment, addressing medical blind spots and enhancing the competitiveness of the domestic medical industry through overseas market expansion.
KTC President Sungil Ahn stated, "We have taken the first step in overcoming the limitations of existing treatments and developing and commercializing new medical devices. We will continue to explore various support measures to ensure domestic export companies remain competitive in line with industrial changes."
