Proof lies beneath the surface – the DermaLock Abutment

For more than 30 years, titanium implants have been used in bone conduction hearing implant systems. Titanium is a truly remarkable metal with unique properties that make it ideal for human implantation. Its ability to osseointegrate (bond) with bone is the key to making a Baha System work.

Up until a few years ago, the abutment (part of the implant that sticks through the skin) was also made completely with titanium. While ideal for bonding with bone, titanium does not bond with soft tissue (skin and underlying layers). That’s why it used to be common practice to thin the soft tissue around the abutment. This technique worked well and is still performed today in some cases. However, there are many benefits to preserving the soft tissue around the abutment. These include faster surgery time, aesthetics and leaving in place as much of the body’s natural structures as possible to help prevent infections.

If you DON’T thin the soft tissue around a pure titanium abutment, the skin heals down around it instead of bonding with it. This creates a pocket between the abutment and the skin where debris and bacteria can accumulate. It also blocks the immune system from accessing the area, so it’s not able to fight off potential infections to keep the area healthy.

Scientists knew there were benefits from soft tissue preservation but also knew that titanium alone was not the solution. So that’s the challenge that Cochlear set our research and development team – create an abutment that would bond with the surrounding soft tissue.

In 2013 we released the first abutment specifically designed for soft tissue preservation – the Cochlear Baha DermaLock Abutment (BA400). The abutment is still made of titanium, but features a special surface scientifically known as Hydroxyapatite. This is a substance that is found naturally in your body. It’s what allows your teeth to stick out through your skin and remain healthy and bonded to your gums.

Titanium surface on Baha bone conduction implant

Close up view of a smooth titanium surface. Soft tissue does not bond with titanium the same way it does with bone.

DermaLock surface on Cochlear Baha implant

Close up view of the DermaLock surface, proven to promote integration (bonding) with soft tissue.

What is DermaLock

Baha user Randi with the DermaLock Abutment. No need for hair removal or skin thinning around the area

Before we release new technology there is a lot of work and research that goes into making sure our products will improve the lives of the people who rely on a Baha System to hear and be heard everyday. And after new technology is released there are always numerous, long-term, independent clinical studies that take place to evaluate and verify the benefits. By design these studies often take years to complete. This is of course also true for the DermaLock Abutment.

And now the results are in!

Researchers at Maastricht University Medical Center in the Netherlands have presented results that show integration actually happening in real people. They used advanced imaging techniques to study both a DermaLock Abutment and a traditional titanium abutment (used primarily by other companies) and how they react with the surrounding tissue.

They concluded that only the DermaLock Abutment achieved integration with soft tissue. This is a great achievement and proof that Cochlear’s dedication to innovation ensures people with a Baha System have access to the latest technology that helps to make hearing carefree.

“This study shows the importance of not only choosing the right Baha sound processor, but also an abutment technology that is accepted and integrated by the patient’s own tissue,” says Stina Wigren, MSc in Materials Science and biomaterials specialist at Cochlear Bone Anchored Solutions. “Cochlear developed this ground breaking technology and is the only bone conduction company in the world that offers this. Strong research evidence underlies our continual improvement and innovative use of technologies.”

titanium surface on Baha abutment

This sample was taken from around a titanium abutment. The dark blue layers resemble the outer layers of skin, clearly showing that no soft tissue has bonded to the abutment.

dermalock surface on Baha abutment

This sample was taken from around a DermaLock abutment. The soft tissue has not hardened and resembles inner, living layers of skin. This indicates a bond with the DermaLock surface.

Read the whole article here.

 

 

Guest blog: Prof. Stokroos from Maastricht shares his experiences with the DermaLock technology

Prof. Dr. R.J. Stokroos, Otolaryngologist

Prof. Dr. R.J. Stokroos, Otolaryngologist

It is with great pleasure we introduce our first guest blogger of the Baha Blog, Professor Robert Stokroos from Maastricht University Medical Center, the Netherlands. For over 20 years he has been leading research efforts in the field of bone conduction. He is currently leading a pan European evaluation of the improvements provided by the DermaLock technology. In this post Prof. Stokroos presents his team’s experience:

“Percutaneous bone anchored hearing devices have changed hearing possibilities for many patients over the years. Since 1992 as a junior doctor, I was involved in this treatment when Baha surgery was still considered very special.

Since then, things have changed a lot. The Baha has become part of our daily clinical practice. As our clinical experience in Maastricht grew, the downside of having a percutaneous implant became apparent.

From our earlier studies we conclude that, as far as Baha surgey is concerned, less is more.

In other words, when working with the old generation of implants the less skin we reduced, the less scar tissue and the better the patient outcome. This was contradictory to what we previously had learned from our seniors, who taught us the importance of skin reduction and having immobile skin around the abutment. In fact, if there was a problem, we blamed ourselves for not thinning the skin sufficiently.

With the introduction of the new DermaLock technology, we feel skin reduction is now unnecessary. The abutment coating prevents the skin from growing down around the implant, thereby naturally keeping it in place.

The clinical impression has been extremely promising. The new technique in combination with the DermaLock has quickly gained wide global acceptance.

Our job as academics is to confirm all these great developments. A pan European effort has been assembled with centers from France, Spain, Sweden and the Netherlands to compare outcomes when using the traditional surgical technique to the latest surgical technique with the DermaLock Abutment.

Our clinical impression is that this is a major step in improving patient outcomes. Soon we will start analysing results. I’ll keep you posted!”

~ Prof. Dr. R.J. Stokroos

Do you have a question for Prof. Stokroos? Let us know in the comments section!