Elitac Wearables has registered the BalanceBelt, a unique, wearable treatment for patients with severe balance disorders, officially as a Class 1 Medical Device with the European Union Medical Device Regulation (MDR). Adherence to the MDR norms attests that the BalanceBelt was developed according to EU MDR patient safety standards and product quality and reliability norms.

15 November 2021, Utrecht (Netherlands) – The BalanceBelt is meant for people suffering from Bilateral Vestibular Hypofunction or Loss (BVH/BVL). These disorders, in which the balance organs in both ears are either impaired or completely non-functional, did not have any sustainable or non-invasive treatment options previously.

Facilitating international distribution

Explaining the decision, Erland Fuglsbjerg, Managing Director of Elitac BalanceBelt B.V. said, “Since we launched the BalanceBelt, we have had growing international interest from patients, physicians and distributors. However, in regions that accept the CE mark, the Class 1 Medical Device classification is required for physicians to prescribe the solution to patients. This registration allows us to enter all the markets that accept Class 1 Medical Devices with a CE mark and reduces many of the costs associated with importing a medical device. This way, we can make the belt available to many more people suffering from BVH/BVL.”

Increased focus on developing medical wearables

The BalanceBelt was developed by Elitac Wearables in collaboration with renowned vestibular expert Prof. Dr Kingma and the Maastricht UMC+ (NL). It is one of several medical wearables developed by the Netherlands-based wearables development company. The company specialises in integrating textiles and electronics, with a particular focus on haptic feedback and sensors.

The BalanceBelt’s MDR registration illustrates Elitac Wearables’ increased focus on developing more wearable medical devices in the future. Co-founder and CEO Merijn Klarenbeek explained, “We see unparalleled potential for wearable technology to improve the lives of people suffering from medical conditions and the standard of medical care.”

“That’s why we are taking steps to achieve ISO 13485 certification for our company. Developing wearables in adherence to this international standard will help ensure that we consistently keep designing, developing and producing medical wearables that are safe to use. We are currently reviewing all our processes and expect to achieve the ISO 13485 certification for our company during the course of 2022.”

“As for the BalanceBelt, its registration as a Class 1 Medical Device is an important step toward helping as many BVH/BVL patients as possible benefit from this unique treatment.”

So you purchased the belt and have been using it ever since. Does it still help you feel more confident?
Yes, absolutely! I feel much more confident, I don’t have to keep watching the floor when I move. Before, I was always watching the floor, I was afraid to lift my head and look around! It’s also really easy to use, to turn on and off.

I’m still a little scared of walking down stairs, though. But I guess that’s normal at my age!

Many thanks for talking to us, Mrs Carmen Lajusticia Martinez!

How did this diagnosis affect your life?
I lost my independence completely: for a year, I was reliant on my husband to go anywhere or do anything.

How long have you had the BalanceBelt?
I am one of the earliest users, I’ve been using the BalanceBelt for 6 years now, since 2014. I started with the old prototype and, since 2019, I’ve been using the new, lighter version developed by Elitac Wearables.

What does the BalanceBelt mean to you?
Most importantly, it has given me back my independence: I am much less reliant on others. And it helps me enjoy activities again that had become difficult or impossible due to my balance disorder, like visiting friends and shopping, but also my great passion, travelling.

Together with my husband, I’ve been fortunate enough to make some wonderful journeys over the years: to Greenland, Iceland, Norway, we rode dogsleds in Lapland and saw penguins in Antarctica, it was fantastic! But after my diagnosis it looked as if our travelling days were over and our world had suddenly become a lot smaller.

So, you can imagine how happy I was to realise that with the BalanceBelt I could still travel. It is true, I’ve needed to make a few adjustments, such as requiring extra assistance at the airport and a medical certificate for the security checks (explaining that the BalanceBelt is not a dangerous device), but it is still possible!

For example, we visited Mallorca with our children last year. And a few years ago, I even travelled to Alaska with the BalanceBelt, and walked among the Kodiak Bears (the largest breed of grizzly bears) with a friend. Without the BalanceBelt, this would never have been possible!

When do you use the BalanceBelt?
When I go out, to walk, do groceries, visit family and friends. And when family and friends come to visit me. These situations can often be a bit hectic as you need your concentration everywhere at once: serving coffee, talking and listening, and the BalanceBelt is invaluable in those situations as well.

Other than that – not quite as enjoyable, but necessary nonetheless – when I’m doing chores around the house, such as ironing, changing the bedding, cooking and so on.

Would you recommend the BalanceBelt to someone with a balance disorder?
Yes, absolutely, I would recommend the BalanceBelt to anyone who suffers from a balance disorder.

Could you describe the difference between walking with or without the BalanceBelt?
Of course I can only speak for myself, but it feels as if the connection between my brain and my body has been severed. It’s like my body wants to go to the right and my brain to the left, and that is exhausting.

With the BalanceBelt I still need to concentrate, but much less. This means I tire less quickly and feel more confident when I’m moving around. Nowadays, I never leave the house without the BalanceBelt.

Many thanks for sharing your experiences with us!

How did this diagnosis affect your life?
It changed my life completely. Losing function in both my balance organs made it difficult to sit down and get back up. Just standing still would cause my legs to start shaking and indoors, I could only keep my balance by walking with my legs wide apart. Walking outdoors was even more difficult and I became reliant on using a walking frame or stick. Maintaining my previously active lifestyle seemed like an impossibility until I tried the BalanceBelt.

How long have you had the BalanceBelt?
I’ve been wearing it since November 2019.

What does the BalanceBelt mean to you?
It means a great deal, it has improved my life in many ways. Thanks to the BalanceBelt, I can walk outdoors again without a rollator, although I do still carry a stick for safety (and for kerbsides). My family almost couldn’t believe it when they first saw the difference in the way I move around! I don’t think I could live without the BalanceBelt anymore.

I’ve always led a very active life, playing golf, walking and cycling. Unfortunately, golf isn’t possible anymore, but I can cycle again with a few smart modifications. When I first tried cycling again after my diagnosis, I fell quite badly because my eyes had trouble finding an orientation point.

However, my stability has really improved since I had adult training wheels fitted to my e-bike. Each spring I visit Dutch Flanders with my wife, where we cycle often. It’s beautiful there! Back home I use my bicycle to run errands or to go to the physio, for example. And I wear the BalanceBelt to keep me stable when I get off the bike.

What I’m really happy about is that I can go walking again. During the day at least, at night I still don’t like to walk outside, even with the BalanceBelt. It is simply too difficult to find my orientation in the dark. But in daylight, I walk about 1-2 miles most days, in nature, or just to go to the shops. I’m turning 78 this year and I’ve also just had a hip replacement, so I’m quite content that I can still live such an active life.

When do you use the BalanceBelt?
I mostly use it to go walking, do groceries and when I go cycling, for when I get off the bike.

Could you describe the difference between walking with or without the BalanceBelt?
Without the BalanceBelt I walk with my legs wide apart and as if I’ve had a drink too many. When I’m wearing the BalanceBelt, people around me often don’t even notice that I have a balance disorder.

Would you recommend the BalanceBelt to someone with a balance disorder?
Yes, absolutely. Thanks to the BalanceBelt, I am still able to live an active life, which wouldn’t otherwise be possible. So I would recommend it to anyone with a comparable balance disorder: Try the belt and see if it helps you as well.*

Many thanks for sharing your experiences with us!

Originally a biophysicist, Prof. Kingma has been studying and treating balance disorders since he joined the Vestibular Clinic of Maastricht University in 1983. In 2002, frustrated by the lack of treatment options for his patients, he decided to develop a balance aid wearable himself. Nearly 18 years later, the BalanceBelt is launched and available worldwide to patients with balance disorders. We caught up with him on a video call.

Welcome, Prof. Kingma. It must be a busy and exciting time for you. Yes, after so many years of testing and developing the BalanceBelt, it is finally ready for daily use and production at scale. I cannot tell you how happy I am that more balance disorder patients will now be able to experience the positive effects of the BalanceBelt.