Description This session provides a practical roadmap for transforming a clinical idea into a marketable medical device. We will navigate the critical pathway from initial concept and prototyping to intellectual property, regulatory approval (FDA/CE), and commercialization strategies.

Outcome Objectives Participants will be able to:

1. Outline the key stages of the medical device development lifecycle.

2. Identify critical regulatory and intellectual property considerations.

3. Describe strategies for funding and commercializing a new device.

Background Many groundbreaking medical ideas fail not due to clinical merit, but due to the complexities of the development and regulatory process. This guide provides the essential business and legal framework needed to successfully bring innovation to patients.

How to predict hearing aid outcomes using AI

Patent application and practise in the medical area

Innovative approaches and key findings in the inner ear

Description

this session highlights the latest research and innovation in ear and hearing science, aligned with the mission of the mirko tos ear & hearing research center. We explore cutting-edge developments, ranging from molecular biomarkers for early diagnosis to minimally invasive surgical techniques. Key topics include novel auditory implants, tinnitus management strategies, and translational research on inner ear pathophysiology. By bringing together audiologists, surgeons, and basic scientists, we aim to accelerate the development of personalized therapies for complex auditory and vestibular disorders.

outcome objectives

upon completion, participants will be able to:

1. identify emerging trends in middle ear surgery and hearing rehabilitation technologies.

2. evaluate the clinical utility of new diagnostic biomarkers for sensorineural hearing loss and tinnitus.

3. apply multidisciplinary, evidence-based strategies to improve patient outcomes in the management of chronic ear disease and vestibular dysfunction.

Tinnitus is a common issue, especially among older adults, and affects many people in japan. In 2019, japan released its first guidelines to support better care, focusing on counseling, sound therapy, medication, and psychological support. Most treatment is provided by ENT doctors, with care tailored to each person. This proposal will introduce how tinnitus is managed in japan and how a combination of medical and supportive approaches helps improve quality of life.

Stem cells in cochlear cells regeneration