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.
Meeting Highlights
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.
Surgical Techniques
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.
Product Design
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.