The 117th American Academy of Otolaryngology (AAO) Meeting took place in September and the 29th Politzer Society took place in November. Ravi Sockalingam, PhD and Director of Clinical Research at Oticon Medical took part in the meetings, which both included several sessions on bone anchored hearing systems. Here’s Ravi’s account of the meetings and information shared and themes of each.
Some of the meeting sessions touched on surgical techniques– one particular session focused on loading timeframe. Loading is the time when we put the sound processor on the abutment. Patients will have surgery, and then we wait until the skin heals before we put the sound processor onto the abutment. The FDA indications say three months before loading. Many doctors feel it is safe to put the sound processor on at six to eight weeks post-op. There is now more evidence indicating that even a three-week loading does not increase the risk of an implant extrusion or adverse skin reactions. Dr. Jack Wazen at Silverstein Institute in Sarasota reported no differences in outcomes between loading at three weeks and loading at six weeks. The outcomes at 3 weeks loading were reported to be good with no revision surgery or implant extrusion, and the skin reactions were either nonexistent or very minimal.
Three week loading is a discussion for adults with normal bone quality. Surgery for children was also discussed. There is some development on the pediatric side about whether the surgery should be done in a single-stage or two stages. Typically, surgery in children is performed in two stages because they have softer bone.
Surgeons would want to put the implant in first, wait for three months, and then put on the abutment. Then they would wait for another three months or so to be fit with the sound processor. There are centers here in the United States that do the surgeries in one stage. They place the implant and the abutment at the same time, just as they do in adults, and wait for three months before they load the sound processor. It depends on the quality of the bone before the surgeon decides whether it is going to be single stage or two stages. The rule of thumb is, if a child is over 12 years old, the surgery is not staged, provided the quality of the bone is good. If the child is under 12 years of age, then surgery is staged.
For a long time the surgical technique employed was one that involved thinning of the skin and removing tissue around the implant site. Later, a linear incision technique, whereby a small straight line incision is made, was adopted by many surgeons in Europe and in the US. More recently, more and more surgeons are using a linear incision technique with minimal or no tissue removal. These surgeons are reporting better skin outcomes with this technique.
There are also, surgeons, particularly in the US, who have been using what we call a punch technique. They make a very small, circular 5 mm punch and put the implant and abutment in. Among the surgeons who perform the “punch” technique are Dr. Wayne Shaia from Richmond, Virginia and Dr. Daniel Coelho from Virginia Commonwealth University, also in Richmond. I always joke that Richmond is the punch capital of the world now. They are reporting good outcomes with this technique.
The linear incision technique with minimal or no tissue reduction, and the “punch’ technique aim to preserve as much soft tissue as possible. Often times these techniques are collectively referred to as “Tissue Preservation technique”. Long term data indicate that this technique results in quicker healing, better cosmetics, fewer postoperative complications, and shorter surgery time.
The modern design of our implant itself lends itself to tissue preservation surgery very well. We have a smooth titanium surface on the abutment that adheres to the skin and supports it very well. You may have to use the longer abutment if you are using the tissue preservation technique because you are not removing any tissue. You will typically use at least a 9 mm abutment. In some cases, surgeons use a 12 mm abutment. There is an ENT professor at the Karolinska Institute in Stockholm, Sweden who has been following patients for five years using the non-skin reduction technique and a longer abutment. She has been reporting very good outcomes, even up to five years.
The next hot topic is a transcutaneous solution. In a transcutaneous solution the battery and other components are on the outside. You have to use the power to transmit the signal. Implanted inside are magnets and a receiver. The receiver will transmit the vibrations to the bone. “You are still going to lose some energy across the skin. It will never be better than the bone conduction vibrator that you would use to measure bone conduction thresholds, because that oscillator is in tight contact against the head. For children who are under the age of five and cannot have the surgery, we put a processor on a soft band. You try to make it as tight as possible. If it is too tight, there will be an indention in the skin, and that can be painful after a while. That is what transcutaneous solutions do. Cosmetically, it is appealing, but you are not going to have the same amount of output and gain that you would from a percutaneous system.
Bone Anchored Solutions
Bone Anchored Solutions are getting more public awareness. We are reaching out to consumers directly through social media. We also have patient advocacy weekends and retreats, picnics, and so forth. The consumers are becoming more knowledgeable about bone anchored hearing systems, and they are educating other potential consumers.
Patients are empowering themselves with the information they find online, and in some cases they’re even educating their professionals. I work closely with some of the surgeons and they say some of the patients show up saying, “I need a Ponto. Do you do that? What is the price? When can you do it?” They are not coming for an evaluation or opinion from the doctor. More and more of that is happening, especially with the baby boomers, who are better educated, particularly those living in urban areas. This is, in fact, a topic that is being discussed in current conferences.
Do you have a question for Ravi? Let us know in the comments section below.
Daniel H. Coelho, MD, FACS specializes in Otologic & Neurotologic Surgery. He is assistant professor of Otolaryngology, Physiology and Biophysics, and he’s the director at the Cochlear Implant Center at Virginia Commonwealth University School of Medicine in Richmond, Virginia. Following his training in Otolaryngology, Dr. Daniel Coelho completed a two-year fellowship in skull-base surgery. He began practicing minimally invasive linear surgery 5 years ago, and was an early developer of the punch method about two years ago.
“On day one of medical school we learned that you have to respect the tissue.”
Progressive surgeons like Dr. Coelho spend a great deal of their time studying outcomes and working together to improve surgical procedures. Yet, very few patients are aware of the surgical implant techniques used for bone anchored hearing devices. Many only know of the traditional skin-graft technique, which causes a visible scar and frequently results in skin overgrowth and post-surgical irritation. Today, we’re sharing information about a new technique that Dr. Coelho uses. It’s a minimally invasive technique to optimize tissue preservation.
The procedure takes about 10 minutes and is typically done under local anesthesia. As most users have experienced, patients can expect a bit of soreness for a few days afterward. But, with little pain and no narcotics, patients can go back to work or normal routines the day after the procedure. This is all because the whole process is designed with tissue preservation in mind.
Tissue preservation is important for several reasons. It contributes to a very short amount of recovery time, and there’s little -to-no scaring and no hair removal. The bottom line is that the tissue preservation is minimally invasive, which improves overall results.
The fact that the procedure is minimally invasive is the most important aspect of a surgical procedure. “The more trauma there is, the more inflammation and scarring. While scarring isn’t ideal cosmetically, it also means less predictable tissue – the implant and the abutment are foreign objects that the tissue can work to reject,” Dr. Coelho explained.
Tissue preservation is incredibly important in function—it’s one of the most important aspects of the surgery. And it’s all possible since the introduction of longer abutments. “The Ponto is an excellent product and a major advancement was the development of the longer abutment. With a longer abutment, it’s no longer necessary to thin out the tissue to prevent the processor from touching the skin. If you’re going to be doing tissue thinning and suturing, those are traumatic to the skin and soft tissue and may result in an increased inflammation. Inflammation can lead to scarring, tissue overgrowth, loss of sound quality and eventually to non-use.” As as an added benefit, less tissue inflammation also yields excellent cosmetic outcomes.
In the 70-80’s, an abutment was 5 mm or less. “The only way to get the processors to function without rubbing against the skin (and compromising sound quality) was by undermining the skin” Dr. Coelho recalls. “Once the new, longer abutment came out, and the sound quality was shown to be equal, it showed that any additional skin manipulation was not necessary.” Oticon Medical was a leader in introducing the longer abutments, giving surgeons increased flexibility to adapt to individual variations in skin thickness and accommodating new clinical developments in surgical techniques, including tissue preservation.
The improved technology enables medical providers to focus on other factors like continuously iterating surgery to be as minimally invasive as possible. “Patients are happy with the functionality and the great cosmetic outcomes— it’s truly as minimally invasive as you can get.”
Melissa Tumblin, founder of Ear Community asked Dr. Coelho, “What are the common concerns about skin irritation? What do you recommend other than the cortisone cream and general cleanly maintenance?”
“First of all, hygiene shouldn’t be blamed for everything. Some people just have a more robust reaction to that foreign object—just like people have allergies worse than others.” Dr. Coelho explains that some people even clean too frequently, which can irritate the area even more.
Dr. Coelho has had no skin overgrowth, as of 2-year follow-ups, with his own patients that received their implant via the punch technique. When he does treat overgrowth, it’s in patients who had the traditional technique. For overgrowth, Dr. Coelho uses clobetasol cream, a topical steroid to help reduce the number of surgical revisions. But, he points out that there is a longer term solution. “Surgical revisions only buy time, they do not actually fix the underlying problem. But, the longer abutments theoretically do. Because it’s such a simple procedure to switch, people who were getting the steroid shots are now making the change. The abutment change procedure is done in the office and takes seconds—some insurance companies are covering the abutment switch.” Patients can also immediately go back to wearing their processor unlike some of the corrective treatments.
Overall, more surgeons are slowly, yet surely, implementing the minimally invasive procedure. Dr. Coelho predicts that within 5 years it will be the standard. “Surgeons learn from colleagues, conferences, journals and the industry as well. People expect to see a divide between industry and medical providers, but many technological advances are made by industry organizations or through a collaboration with clinical professionals – this open line of communication benefits everyone.”
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