Innovative dizziness therapy system now certified as medical device
The biofeedback systems EQUIFit© and EQUIMedi© are now approved as medical products for dizziness therapy and gottherefore CE approval. The marketing launch was scheduled for end of 2020. The devices are the main components of the EQUIVert© solution, which researchers at the Fraunhofer Institute for Microelectronic Circuits and Systems in Duisburg developed together with colleagues from the University of Duisburg-Essen, GED Gesellschaft für Elektronik und Design mbH and Dr. Uso Walter from HNOnet NRW eG.
The approval according to the Medical Devices Act (MPG) for EQUIFit© and EQUIMedi© is based on a multi-stage, labour-intensive and time-consuming examination with many audits, risk management assessments, clinical evaluations and risk-benefit analysis. As a notified body, DEKRA Certification GmbH carried out the entire procedure at and with the electronics company GED. "Those involved were very pleased about the approval," says Burkhard Heidemann, head of department at Fraunhofer IMS. "Everyone in the development team is proud that we got CE approval. This proves that we meet the strict requirements of the current Medical Devices Act. The great effort and the long way have been worth it."
The EQUIVert© products are ready for series production. As biofeedback systems with audio functions, gesture control, data processing and transmission, the devices offer users solid quality and sophisticated haptics in a modern, very appealing design. The pilot series is currently in production. A new EQUIVert© website (www.equivert.de) has been launched; the webshop is scheduled to open at the end of the year. Orders will be possible from mid-December.
EQUIFit©: simple and effective training
The devices in the form of headphones and the accompanying software are intended to help many people with dizziness symptoms to alleviate their complaints. The background: In a healthy body, several organs and functional systems ensure that people can stand upright and walk safely. Sensors in the inner ear detect the movements of the head and provide the brain with information about the direction of movement. The eyes provide the brain with further information about the orientation of the body in space. Sensors in the skin, joints, muscles and tendons complete the information. If one of these systems is disturbed - for example, by diseases in the inner ear or an inflammation of the nerves - the organ of equilibrium provides false signals. This leads to dizziness. If you train your balance, the brain learns in the long run how to deal with the wrong signals. When training with open eyes, the eyes take over a large part of the sense of balance (optical compensation). However, if you are in a dark room or close your eyes, they can no longer perform this task. The dizziness therefore often returns in the dark. Training with closed eyes, however, could be a dangerous affair.
EQUIVert© eliminates this shortcoming. Those affected put on their EQUIFit© training device with integrated acceleration and rotation rate sensors and receive instructions via the headphones, for example, to stand up straight with their eyes closed. The persons are guided by acoustic signals: If they sway too far to the right, for example, a tone sounds via the headphones that seems to come from the right - similar to a parking aid. The system checks how well patients complete the exercises and switches to the next higher training level if they are successful. The headphones thus provide the users with balance feedback that does not come via the eyes, but via the ears, which are closely linked to the sense of balance.
A completely new operating concept was developed especially for older people, who are often not so tech-savvy. The system is operated largely without buttons or switches by means of a so-called "gesture control". Voice prompts are used to ask questions that can be answered by simply nodding or shaking one's head. In this way, yes and no commands are used to make individual settings and control the exercise programme. The loudness/quiet setting can be changed with a light tap on the headphones. After the basic settings, users receive the announcements for the training exercises, which they repeat daily. For this purpose, the intelligent system guides them through the training programmes at different levels of difficulty. Patients are only switched to the next higher level according to their respective measured values if they meet defined threshold values in the level they have already successfully completed. This prevents overexertion and ensures safety.
EQUIMedi©: Optimised dizziness diagnosis
EQUIMedi© sets new standards in medical diagnosis of dizziness. Instead of just using their eyes and experience to estimate how securely patients are standing, doctors can use the EQUIMedi© device to measure the fluctuations precisely. The results are transmitted by cable to the doctor's PC, where they are processed by the EQUISoft© analysis programme and displayed visually.
Many specialists are now able to diagnose dizziness objectively for the first time. Until now, diagnostic systems have been used, if at all, in which patients stand on measuring plates that use integrated sensors to measure the center of gravity of the body when standing (post urography). However, at 6,000 to 10,000 euros, such a device is too expensive for most practices. EQUIMedi©, on the other hand, delivers better results at a fraction of the cost - and the EQUIFit© patient device is also offered at a price that is affordable for practices.
Burkhard Heidemann is looking forward to the market launch of the devices: "Dizziness is almost a widespread disease that is often underestimated. With EQUIFit© and EQUIMedi© we are now taking big steps forward in therapy and diagnosis."
You can find more information at www.equivert.en
About the Fraunhofer IMS
The Fraunhofer Institute for Microelectronic Circuits and Systems IMS in Duisburg is a globally recognized research institution for the development of innovative technologies and processes in microelectronics, smart sensor technologies and embedded artificial intelligence. In the business units "Health”, “Industry”, “Mobility”, “Space and Security”, scientists and engineers create innovative and sustainable solutions for the industry, the service sector and the society - for more than 30 years.
The Fraunhofer-Gesellschaft, headquartered in Germany, is the world’s leading applied research organization. With its focus on developing key technologies that are vital for the future and enabling the commercial exploitation of this work by business and industry, Fraunhofer plays a central role in the innovation process. As a pioneer and catalyst for groundbreaking developments and scientific excellence, Fraunhofer helps shape society now and in the future. Founded in 1949, the Fraunhofer-Gesellschaft currently operates 75 institutes and research institutions throughout Germany. The majority of the organization’s 29,000 employees are qualified scientists and engineers, who work with an annual research budget of 2.8 billion euros. Of this sum, 2.4 billion euros are generated through contract research.