Tinnitus, characterized by symptoms such as a 'ringing' or humming sound in the ears without external stimuli, affects about 20% of the population. While stress and psychological factors contribute, hearing loss due to aging is considered the major cause. As the cochlea responsible for hearing ages, sensorineural hearing loss occurs, impacting the auditory cortex in the brain and resulting in tinnitus symptoms.
Tinnitus can be accompanied by dizziness, anxiety symptoms, and depression, and in severe cases, can lead to dementia or extreme thoughts. Recently, the number of patients has surged due to aging. According to the Health Insurance Review & Assessment Service, the number of tinnitus patients in South Korea rose steadily from 280,389 in 2010 to 343,704 in 2022. Globally, about 740 million adults experience it.
However, there is no suitable treatment available. Currently, tinnitus patients are prescribed blood circulation medications or tranquilizers, which only provide temporary relief. As a result, many patients suffer from tinnitus while giving up on treatment.
Domestic medical professionals have developed a new treatment method. Instead of oral medications or injections, it is a digital therapy (DTx) called 'SoriCLEAR' that utilizes software technology to prevent, manage, and treat the disease. Developed by NEURIVE, founded by Professor Song Jae-jun of Korea University Guro Hospital's otolaryngology department in 2018, it received product approval from the Ministry of Food and Drug Safety on the 22nd.
Digital therapies have shown efficacy not only for insomnia and depression recently but also for various neurological disorders, leading to an expansion in their use. When combined with medication, devices, or other therapies, treatment effects are enhanced, and they can be developed more quickly than conventional drugs, garnering attention worldwide. SoriCLEAR is the '5th domestically produced DTx.'
On the 22nd, during a meeting at Korea University Guro Hospital, CEO Song noted, 'Tinnitus is not merely a nuisance but a refractory condition with no suitable treatment.' He explained, 'We developed SoriCLEAR, a DTx that digitalizes counseling and education to prevent the vicious cycle of unstable emotional states caused by recurring tinnitus.'
After graduating from Korea University College of Medicine, CEO Song obtained his master's and doctorate degrees at the same university and has worked for 24 years as an otolaryngologist. During his 10 years researching tinnitus treatment through various national projects, he founded NEURIVE for the development and commercialization of dedicated treatments. Professor Choi Hyuk of Korea University College of Medicine has participated in technology development since the early stages of the founding and currently serves as the chief technology officer (CTO).
SoriCLEAR quantifies patients' age, gender, tinnitus frequency, and size, using artificial intelligence (AI) to predict the patient's disabling factors and treatment targets, then provides the most suitable tinnitus treatment program tailored to the patient. This hospital-use DTx allows medical professionals to download an app to use for patients.
CEO Song plans to apply for a deferment of the new medical technology evaluation for SoriCLEAR at the Korea Health and Medical Research Institute (NECA) to promote its non-reimbursed use in medical institutions.
The new medical technology evaluation is a process to verify the safety and efficacy of new medical technologies before they are used in clinical practice. However, even after obtaining product approval, it takes at least another year for patients to start using them. In response to concerns, the Ministry of Health and Welfare allowed certain medical technologies that meet specific criteria, approved by the Ministry of Food and Drug Safety in 2015, to be used in the market as non-reimbursed items. Four years later, a system was established requiring them to undergo new medical technology evaluations.
CEO Song mentioned, 'We are discussing the introduction of SoriCLEAR with various hospitals beyond Korea University Guro Hospital,' and added, 'If we push for international exports in the future, we plan to add various languages, including English, so that patients worldwide can utilize it.'
NEURIVE is also developing an electronic drug that treats tinnitus by delivering electronic stimulation to the brain. 'Soricle' is a headphone device used in both ears, which treats by electrically stimulating the ear region (auricle) associated with the vagus nerve that regulates the autonomic nervous system. The principle is that AI-controlled electrical stimulation increases blood flow in the brain and neurotransmitters, calming the excitation of the auditory cortex that causes tinnitus. It also has effects on mental stability and enhancement of concentration.
Soricle is currently undergoing clinical trials for approval and aims to submit a domestic product approval request within this year. On the 17th, it first received product approval in Brazil, making it available in the South American market. It also won an innovation award in the digital healthcare sector at CES 2023, the world's largest IT and electronics exhibition.
CEO Song stated, 'By stimulating the vagus nerve in the brain to activate the parasympathetic nervous system, numerous diseases that can be cured, including tinnitus, insomnia, depression, and chronic pain, can be addressed. We will optimize the vagus nerve stimulation method for each disease to enhance the quality of life for many patients.'
NEURIVE is also actively researching the treatment of drug addiction patients through vagus nerve stimulation. CEO Song explained, 'Drug addiction patients typically experience severe withdrawal symptoms due to the over-excitation of the sympathetic nervous system, but I believe this can also be alleviated by activating the parasympathetic nervous system,' adding that preliminary clinical trials conducted at Incheon Cham Sarang Hospital, a drug addiction treatment facility, confirmed its effectiveness.
CEO Song is preparing for full-scale clinical trials to prove the anti-addiction effects of Soricle. If proven effective, it will also be applied to alcohol and nicotine addictions.