Celebrating More Than 35,000 Baha® DermaLock™ Users

In 2013, after years of pre-clinical research, Cochlear launched the first abutment designed for soft tissue preservation surgery – the Baha BA400 (DermaLock) Abutment featuring a hydroxyapatite surface. The new tissue-friendly abutment allowed a major change to the surgical procedure that would preserve the natural appearance and healing capacity of the skin, while reducing time in surgery.

Now, going on five years since its introduction, we are celebrating an amazing 35,000 people who hear today with a Baha Connect System that features this breakthrough technology!

Interested in learning more about the hydroxyapatite surface, the clinical evidence and science behind the technology? Here are some great links to articles and scientific publications.

Whitepaper: Breakthroughs in Bone Conduction Hearing Implants

Blog post: Proof lies beneath the surface – the DermaLock Abutment

Blog post: Prof. Stokroos guest blog on his experiences with DermaLock technology

Scientific article: Can the Hydroxyapatite-Coated Skin-Penetrating Abutment for Bone Conduction Hearing Implants Integrate with the Surrounding Skin?

Scientific article: Osseointegrated hearing implant surgery using a novel hydroxyapatite-coated concave abutment design

Scientific article: Surgical and audiological evaluation of the Baha BA400

What You Need to Know: 10 FAQs on the Bone Conduction Procedure

Have you tried the Baha® 5 sound processor on a Baha Softband and decided to move on with a bone conduction implant? Has your child been scheduled for the implant procedure and you need to know how to prepare?

Jennifer Brown, Clinical Product Manager at Cochlear and audiologist, answers the ten most frequently asked questions about the bone conduction procedure.

Jennifer has more than six years of clinical experience in the United States with both pediatric and adult cochlear implant recipients, and she has worked for Cochlear in a variety of roles for the past four years.

(Picture: an audiologist fits a Baha Softband on a toddler’s head. A Baha 5 sound processor is attached to the Softband)

FAQ

1. How do I prepare for the implant procedure?

The good news is that no special preparations are needed before the procedure. The procedure is fast and minimally invasive. Your physician will give you all the details to plan for a successful procedure.

2. Will the procedure be painful?

The procedure is performed under anesthesia. The type of anaesthesia – local or general – is determined by a number of factors, like age, or pre-existing conditions. Ultimately, which anesthesia is right for you is determined by you and your surgeon. Post-operatively, you may experience swelling or skin sensitivity at the implant site. Should it be necessary, your doctor can prescribe pain reliever. Always discuss the procedure and any concerns you may have with your surgeon.

3. Will I be able to go home from the hospital the same day?

In the vast  majority of cases, patients go home the same day. While rare, sometimes in the case of small children or individuals with multiple involvements, the physician may take a precaution and keep the patient over night, but this seldom happens.

4. Can I shower after the procedure?

Usually, patients are allowed to shower the day after procedure. Avoid rubbing the area when drying as this may knock off the healing cap. Cover the cap area by holding a dry towel over it. Here’s what Dr. Pete Weber said in an earlier post.

“The site will still get wet. Since the incision is now very small for Baha Connect surgery, getting the site wet is usually not an issue. Full shower when cap and packing off. The best shampoos to use are the hypoallergenic ones, such as baby shampoos. I also let my Baha Attract patients shower the next day after removing the dressing. Again telling them to pat dry the area and not rub.”

5. If I choose an abutment or a magnet system, how long after surgery until I can wear the sound processor?

Different countries have different regulations.

  • If you choose the abutment system – Baha Connect: depending on where you live it can be anywhere from two weeks to three months before receiving the sound processor.
  • If you choose the magnet system – Baha Attract: depending on where you live it can be anywhere from two weeks to five weeks before receiving the sound processor.

Your doctor will examine the implant site before fitting the sound processor.

6. Are post-operative skin infections common and how are they treated?

As discussed in question 2, there could be swelling or sensitivity at the implant site after the procedure. Post-operative skin infections might occur, although the probability is low. Most skin-related issues happen in the abutment system, because it is skin protruding. In most cases, issues are mild, and can be resolved medically after consultation with your physician. Usually, the skin issues do not affect your ability to wear the sound processor. In the rare incident of persistent skin issues, it may be beneficial to transition to the magnet system.

7. How do I know if an abutment system or a magnet system is appropriate for me?

Both of the Cochlear Baha systems are indicated for individuals with hearing loss in one ear (single-sided deafness, or SSD), or for individuals with conductive/mixed hearing loss.  Whether to choose a Baha Connect or a Baha Attract depends upon a variety of factors, including the degree of hearing loss.

The magnetic system – Baha Attract – is a transcutaneous, or an under-the-skin implant system.  It is comprised of the internal fixture, with a magnet attached to it.  Individuals with the hearing losses noted above are candidates for this system, but it is important to remember that because the sound must pass through the skin, it may be necessary to use a more powerful sound processor, like the Baha 5 Power or the Baha 5 SuperPower.

The abutment system – Baha Connect – is a percutaneous, or through-the-skin implant system.  It too, uses the internal fixture but has an abutment attached to it.  It is appropriate for individuals with SSD or conductive/mixed hearing loss, but unlike the Baha Attract system, there is no skin attenuation of the sound.   This is a great option for individuals needing more power.

In some instances, it may be possible or necessary to transition from one system to another.  For instance, if a recipient chooses the Baha Attract system, and notices a change in his/her hearing, it is possible to remove the magnet and attach an abutment to eliminate dampening of the sound through the skin and to offer more direct bone conduction. Conversely, if a recipient needs to transition to a completely under-the-skin system because of lifestyle or soft tissue concerns, the abutment can be removed and the magnet can be attached.  In both instances, the recipient can likely continue to use the same sound processor.  Cochlear is the only manufacturer that allows for this flexibility based on the patient’s needs.

8. Why do I have to wait so long before I get fitted with a sound processor?

Bone bonds well to titanium, which is what the internal fixture is comprised of. To allow for osseointegration, it is recommended that appropriate healing time be allotted. In an abutment system, the surrounding skin also needs time to adhere to the abutment, to minimize skin issues. In a magnet system, it is important to wait the allotted time to give a chance for the swelling to reduce so that the patient can wear the weakest external magnet possible and still have adequate retention.

9. Will my child need a new implant as she or he grows?

No, an implant is designed for life. There are no pediatric-specific implants, abutments, or magnets. In the event that the child’s hearing changes, non-surgical options – such as a more powerful sound processor – should be tried first. Only in the event of a transition would a procedure be required, but keep in mind the same internal implant is used.

10. Will the Baha® System affect my child’s choices in sports or other activities?

A bone conduction implant is designed to allow your child a world of sound in every activity. While hearing loss is the most important factor to consider when choosing an abutment or a magnet system, lifestyle plays an important role. Some sports may be more conducive to having an under-the-skin magnet system.  It is important to choose a manufacturer that offers your child choices in hearing solutions – whether an abutment, or a magnet.

Remember, communication is key. Always discuss your options and thoughts with your audiologist and surgeon. Your hearing professional will be able to provide timely, accurate, and documented information.

Applications Open for Graeme Clark and Anders Tjellström Scholarships

It’s finally time to apply for the prestigious scholarships offered by Cochlear Americas! The 2018 Graeme Clark and Anders Tjellström scholarships recognize values like leadership, humanity and academic achievement in students who are Cochlear™ Nucleus® Implant and Baha® System recipients. The awarded students will receive $2,000 per year for up to four years at an accredited college or university, for a total of $8,000 per student.2017scholarshipwinners_400

Picture: Scholarship winners 2017

Since 2002, Cochlear has awarded $568,000 to 80 college students. The scholarships are named after Graeme Clark, the pioneer of the multichannel cochlea implant, and Anders Tjellström, surgeon and the founding father of the Baha treatment. The Graeme Clark scholarship is an award open to Nucleus Cochlear Implant recipients around the world. The Anders Tjellström Scholarship is an award open to Baha system recipients in the United States and Canada.

For more details regarding eligibility and the submission process, check out the Application page.

The application period runs through September 30, 2017. Apply today!

Fourth Decade of Baha Technology

2007 – 2017: visions of tomorrow in state-of-the-art technology technology

When Professor Brånemark accidentally discovered osseointegration in the 1950’s, the scientific community was startled in mistrust. To even dare to think that titanium, an inorganic element would fuse with bone tissue, let alone to try to evolve the observation into scientific research, was considered outrageous. Despite the reluctance that Brånemark met, he continued to study the process of osseointegration. Over the years, the applications of his discovery spread from dental implants to hearing devices, and today millions of people benefit from osseointegrated solutions.

What he have learned from this is that a sparkle of brilliance and a strong belief in great ideas drives innovation. The fourth and the last decade of bone conduction hearing marks the period when technology went full digital power.

“Technology has come a long way. A sound processor that has the capacity to adapt to different noise environments was something we had never imagined possible all those years ago”, said Dr. Anders Tjellström in an interview referring to the current generation of sound processors from Cochlear.

Picture: The Baha®5 Sound Processor is the world’s smallest sound processor, and the only device in its class equipped with Made for iPhone® technology.

In 2015, with the launch of the Baha® 5 Sound Processor, two new technologies emerged that would make the new processors not only much smarter, but also much smaller – without losing any power. The first of these technologies was a totally new symmetrical transducer, BCDrive™, that was twice as efficient as the previous design. For the Baha 5 Sound Processor, this efficiency was used to decrease the size of the transducer, which directly relates to the overall size of the processor. It made the new processor more than 20% smaller than the previous version and opened up the possibility of a new design aesthetic. The sleek design, ergonomics and usability of the device were recognised when the Baha 5 received a Red Dot Design Award in 2015.

The second breakthrough technology allowed direct streaming and control from Apple devices. The Baha 5 was the first sound processor to be equipped with Bluetooth Smart, a low energy Bluetooth protocol built for the Internet of Things (IoT). It allows the exchange of data between the sound processor and iPhone with minimal energy consumption, and is used in most wearable devices today. To exchange simple data is one thing, but to make it possible to stream sound this way requires additional work and technology development. That’s where Apple comes into it. Apple had worked with the hearing aid and implant industry and developed Made for iPhone Hearing Aid technology, which made this direct streaming possible. The Baha 5 System, with the Baha 5 Sound Processor, was the first implantable hearing system to feature Made for iPhone technology,  allowing people to stream sound directly from iPhone and iPad devices directly to the ear! At the same time, a Smart App (Baha 5 Smart App) was released that allowed people to control their sound processor directly from the phone, without the need for any additional devices like neck-worn dongles.

The technological transformations during the decade leading up to the Baha 5 had been incredible.

In 2009, the Baha BP100- the first fully programmable sound processor built exclusively for bone conduction was launched. The processor improved speech understanding by up to 25% compared to the previous generation (Baha Divino).

Picture: Baha® BP100

A year later, in 2010, the implant got its first complete redesign for many years with the launch of the Baha BI300. The BI300 Implant featured a TiOblast™ surface and wider diameter that significantly improved initial and long term stability compared to the previous generation.

In many countries, the proven, early stability of the implant has allowed the time between surgery and fitting (when a person gets the sound processor) to be drastically reduced. Before the BI300 was launched the normal waiting time between surgery and fitting was recommended at three months (to allow the implant to osseointegrate), but today the norm in many countries is only two weeks. This early access to sound, made possible by the BI300, has made a huge difference to the people who use a bone conduction implant system. In the same year, the BA300 Abutment was also released. The shape of this new abutment was designed to help reduce soft tissue complications more common in earlier generations.

In 2011, Baha BP110 Power was to be the first power sound processor with advanced automatic signal processing and it delivered more than 50% improved speech understanding in noise compared to the previous generation (Baha Intenso).

Another major breakthrough took place in 2013 with the launch of the Baha 4 Sound Processor. It was the world’s first wireless processor, and was available with a complete range of wireless accessories. While it looked like the previous generation BP100, the inside was totally new and it featured, again for the first time, a scene classifier that automatically adapted to the sound environment to improve the hearing experience.

But in 2013 the innovations didn’t stop at the sound processor. That year, a new abutment would revolutionise the industry and answer the wishes of users and surgeons alike. The Baha BA400 (DermaLock™)  was the first abutment designed and approved for soft tissue preservation surgery. From 1977 until 2013 the soft tissue around the abutment needed to be removed in order to stabilise the area surrounding the abutment. With a new hydroxyapatite surface designed to integrate with soft tissue, the DermaLock Abutment let surgeons leave the surrounding soft tissue in place, drastically improving the aesthetic results, reducing surgery time and speeding up healing. This is now the standard procedure, and soft tissue reduction is a thing of the past .

Picture: Baha 4®, the world’s first wireless sound processor
Picture: wireless accessories for Cochlear Baha sound processors

Innovative products continued to be developed to broaden the choices available to people with conductive hearing loss, mixed hearing loss and SSD. The Baha Attract System, the world’s first magnetic osseointegrated system, became available in 2014. With its release, the Cochlear Baha System offered more possibilities than ever before. Now people could choose between an under-the-skin magnetic implant, an abutment system, or a non-surgical solution like the Baha Softband which was designed for children to young, or not ready, for an implant.

Picture: The Baha® Attract system – a Baha 5 Power sound processor with a magnetic connection to the implant
Picture: Isabella, Baha Attract recipient

The 2015 launch of the Baha 5 Sound Processor, the world’s smallest & smartest, was followed a year later by the power and super power versions. The Baha 5 Power and the Baha 5 SuperPower provide a fitting range of 55 dB SNHL and 65 dB SNHL respectively, and are designed for patients who need additional amplification due to a higher degree of hearing loss.

The Baha 5 SuperPower was a particularly exciting new product as it was the first super power sound processor that could be worn on the head. The previous version, the Baha Cordelle II, used a body-worn sound processing unit. While it provided people with the amplification to hear well, it wasn’t the ideal solution and work needed to be done. The Baha 5 SuperPower Sound Processor used a unique split-system design that ensured there was enough power to help people with more severe mixed hearing loss, but also gave them the ease and aesthetics of a head-worn solution. Both the Power and SuperPower used the same two revolutionary technologies – BCDrive and Made for iPhone – as the Baha 5 Sound Processor to provide excellent sound quality and direct-to-device wireless streaming.

Picture: The Baha® 5 SuperPower, first head-worn super power processor

Today, the bone conduction technology crafted from four decades of research and revolutionary ideas continues to help people hear and be heard – with increasing ease, improving sound quality and wireless connectivity. From first patient in 1977, to the hundreds of thousands we’re reaching today, we’ve been together from the first sound.

Happy 40th anniversary!

Third Decade of Baha Technology

1997 – 2007: the dynamics of an industry in full motion

With the opening of new markets and excellent results being reported, bone conduction bloomed during its third decade. It would no longer be an emerging practice, but a standardised treatment for people with conductive hearing loss, mixed hearing loss, and single-sided deafness. The word on the benefits of the Baha System for people struggling with these types of hearing loss – living either with no treatment or with only ineffective hearing aids – spread at a rapid pace.

From 5,000 users in 1997 to a staggering 50,000 by 2007, the industry drove innovation in technology and expanded to even more geographical locations.

This decade was memorable already from its start, with the introduction of the first snap coupling in 1997. This new type of connection made it easier for users to attach the sound processor to their implant, and resulted in a reduced need for regular maintenance. A further improved version was released in 1999 (together with a new abutment) that would come to fully replace the bayonet coupling that the previous Baha System had used. This coupling remains the standard coupling technology seen in today’s systems.

The first sound processor to feature the new snap coupling was the Baha Cordelle II, also released in 1999. The new processor replaced the previous Cordelle by improving the body-worn unit. A year later, in 2000, the Baha Compact would be introduced to replace the Baha 360, and feature improved electronics and an optional directional microphone.

Photo: Baha Compact sound processor

The world’s first non-implantable Baha solution, the Baha Softband, was released on the market in 2002. The Softband allowed children to benefit from a Baha System before they were ready for an implant. To date, it is still the recommended solution for paediatric treatment (until a child is ready for an implant) and for demo/trial purposes.

Photo: A Polaroid shot of a little boy wearing a Baha Softband

The year of 2005 is another year that marked a major trajectory shift in the bone conduction industry. It was the year that Cochlear Ltd acquired the Swedish company Entific Medical Systems, the company that had been developing and manufacturing the Baha System as a spin-off from Nobel Biocare (originally Bofors Nobelpharma, a company that was formed to industrialise Brånemark’s osseointegration discovery). A new Cochlear division was set up, Cochlear Bone Anchored Solutions AB, and this division took over the manufacturing and development of the bone conduction system under the Baha brand. That same year, Cochlear launched the Baha Divino Sound Processor. It was the first digital sound processor, a technology that helped to further improve hearing outcomes and allow users greater control.

Photo: Baha Divino, the world’s first digital sound processor

In 2007, Cochlear launched yet another sound processor, the Baha Intenso, which was the first head-worn power device. Like the Baha Divino it also featured digital signal processing, and was suitable for people with up to 55 dB SNHL. This new, complete portfolio gave more people more options; with three devices suitable for different levels of hearing loss – the head-worn Baha Divino (for up to 45 dB SNHL) and Baha Intenso (for up to 55 dB SNHL) and the body-worn Baha Cordelle II (for up to 65 dB SNHL).

Photo: Baha Intenso, the world’s first head-won power sound processor

In the next article, read about the fourth and the last decade of bone conduction hearing.

Second Decade of Baha Technology

1987 – 1997:  more innovation, new countries and the first five thousand patients

Thirty years ago, bone conduction technology was emerging as the treatment of choice for people suffering from conductive hearing loss. Thanks to the excellent results observed from the fitting of the first patients starting in 1977, the development of the bone conduction implant system continued to grow. The interest and awareness of the intervention spread across Europe throughout the 1980’s, with increasing numbers of clinical reports revealing positive outcomes in implant recipients. In the UK, the Netherlands and Sweden in particular, the treatment became more common and part of a choice of options available to people with hearing loss.

The world’s first bone conduction sound processor, the HC-100, which became commercially available in 1985, was followed up by an improved version in 1988 – the HC-200. Within a few years another new processor was launched, the Classic 300, followed closely by the Baha 360 model. Both new processors took considerable steps toward increasing the ease of use of the system.

The Classic 300 Sound Processor was launched in 1993

The Baha 360 sound processor, launched in 1995, was a smaller version of the Classic 300 (pictured). It was the industry’s first miniaturised sound processor and took a big step toward offering a more discreet design that would help users feel more confident when wearing the device. Patients who were fitted with a bone conduction hearing system in the 1990’s reported increased comfort as compared to conventional hearing aids. ¹

A very important milestone was reached in 1996, when the FDA approved the use of the Baha System in the USA. The result of opening such a big, new market was simply amazing – by 1997, five thousand people were hearing better with the help the Baha System!

The year of 1997 was also marked by another crucial event – the launch of the Baha Cordelle. It was the world’s first super power device, designed for people with more severe hearing loss, and was suitable for people with up to 65 dB SNHL. This meant that people who had struggled to hear, despite attempts with hearing aids, would now have access to power levels high enough to compensate for their hearing loss. The Baha Cordelle was also equipped with the first generation of snap coupling that improved the connection between sound processor and implant.

The Baha Cordelle (right), launched in 1995, is the predecessor of the Baha 5 SuperPower Sound Processor (left), launched in 2016.

In the next article, read about the third decade of bone conduction hearing.

 

Sources:

  1. “Baha – A Third Option for Otosclerosis”. Nobel Biocare International Updates 2/96. Volume 5, No.2, 1996, pp. 3

First Decade of Baha Technology

1977 – 1987: the first ten years of bone conduction innovation

On the 7th of June 1977, Gothenburg resident Mona Andersson became the world’s first recipient of a bone conduction implant. Aged 40 by the time of the surgery, mother of one Mona decided to put her trust in the hands of technology – one that was emerging at that time, thanks to the continuous efforts of Professor Brånemark and Dr Anders Tjellström, who understood the benefits of bone conduction and its applications in the treatment of hearing loss.

Mona Andersson was born in Gothenburg in 1937, and already as a child she suffered from chronic infections in both years due to complications of scarlet fever. Her natural capacity to hear had dropped dramatically and it was not long before she had serious problems with her hearing.

At the age of 15, Mona received her first hearing aid, which slightly improved her hearing, at the cost of constant headaches. The quality of sound was poor, and due to her chronic infections, she was not able to wear the hearing aids for longer than three hours, otherwise her ears would start to drain.

For the first time in life, she felt isolated.

“I was always joyful and social. However, when I started using hearing aids, I started feeling embarrassed. I remember that some of my early hearing aids were very difficult to wear. Even today, when I think about those days, I can easily sob”, recalls Mona in a 2017 interview with Cochlear.

(Picture: Mona Andersson)

When she started working at a plastic factory, she realised that exposure to warm temperatures affected her hearing even more. She reached a turning point in 1965 when she became a mother.

“I struggled to communicate with my daughter in the first years of her life. My husband and my mother were incredibly supportive! But my biggest wish was to hear my daughter’s voice”, Mona says.

As a regular patient at the Department of Otolaryngology at the Sahlgrenska University Hospital, Mona had a close relationship to Dr Anders Tjellström.

“I had nothing to lose when I accepted Dr. Tjellström’s proposal to receive a bone conduction implant”, says Mona.

In 1977, Mona underwent the world’s first bone conduction implant surgery, performed by Dr Tjellström at Sahlgrenska University Hospital. The custom-made implant was placed in the right temporal bone, and three months after implantation a hearing aid coupling was connected to the fixture.

(Picture: Dr Anders Tjellström)

Dr Tjellström recalled in an interview that Mona had realised the benefits of her implant immediately. For the first time since childhood, she could hear birds and many other sounds she had never experienced, like the sound of a fly on a window, or ice cubes clinking in a glass.

Two more patients were operated in 1977, and the following year another ten patients received the implant. During these years, it became clear that the new concept gave excellent results with little risk. ¹

In 1982, a unique collaboration between Anders Tjellström, Bo Håkansson and Peder Carlsson, Professors at Chalmers Institute, resulted in the development of the first bone conduction prototype – the HC-100, designed for patients suffering from conductive hearing loss, like Mona.

The HC-100 became commercially available in 1985, and soon after, Tjellström and Håkansson arranged the first bone conduction workshop in Gothenburg to present the first scientific paper on the innovation.

“The delegates who arrived with a sceptical attitude all went home convinced of the benefits of this new technique”, said Tjellström. ¹

By 1987, the research and work on improving the performance of the device had intensified, and only one year was left until the release of a new product.

In the next article, read about the second decade of bone conduction hearing, and how the development boomed over just a few years.

Sources:
  1. Veer, Vik, ENT SpR. “Interview with Prf Anders Tjellström”. ENT & audiology news. Volume 22, no 5, November/December 2013, pp. 73-74