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Interview with Ravi Sockalingam, Ph.D. - Oticon Medical Forum on Bone Anchored Solutions

Ravi Sockalingam, PhD

May 14, 2012

Topic: Oticon Medical Forum on Bone Anchored Solutions

Ravi Sockalingam

CAROLYN SMAKA: Ravi, tell me about the first Oticon Medical Forum on Bone-Anchored Solutions that was held this spring.

RAVI SOCKALINGAM: The purpose was to gather audiologists from across the country to share the experiences and challenges of bone-anchored technology and to discuss possible solutions to these challenges. It was an educational forum to gather more insight on how they see this field evolving in the future. One thing to stress is that audiologists who work in the bone-anchored field are scattered across the country and often work in isolation without much support. There is not much close interaction between audiologists due to location, even those within the same state.

So the idea of the Oticon Medical Forum was to bring these audiologists together and talk intimately about their daily practice and to learn from one another. The big picture was to develop some sort of best-practice guideline or standard for bone-anchored solutions, which is something we don't have now. These audiologists recognize that everyone is doing things differently, so we wanted to start a process of developing a protocol to include tools that we ought to be using preoperatively and postoperatively to best predict and measure postoperative outcomes. Verification was a large factor included in this as well.

The other thing that has become very important over the years, particularly in the United States, is single-sided deafness. There is not much known about single sided deafness, but it comprises a large percentage of the caseload that an audiologist with bone-anchored experience may manage. It consumes almost 90 percent of the patient load in some clinics in the United States. Individuals with single sided deafness are a unique population, so it is very important that we identify and understand the challenges that make these patients different from conductive or mixed hearing loss cases. Audiologists are faced with more than one option to address single sided deafness, both invasive and non-invasive. Understanding how to present these options and counsel patients appropriately is important for audiologists to know. A bone-anchored system is one of these options, unique in technology and fitting strategy.

SMAKA: Can we expect to see a best-practice guideline coming out of this conference then?

SOCKALINGAM: Yes. Before the meeting, we sent out a short questionnaire to these professionals asking what they saw as the main challenges of treating patients with bone-anchored devices and also what they do to evaluate patients, verify the devices, and manage individuals in the short and long term. We also asked how they saw the future of this technology evolving. This questionnaire helped us to tailor the meeting according to their needs.

We compiled all the responses and conducted the whole meeting in a highly interactive, informal, roundtable format. We split the attendees into four "working" groups and had discussions on evaluating patients preoperatively, what tools are used, what are the challenges of using these tools, why there is a difference between the choice of tools, et cetera.

We also invited Michael Valente from Washington University to give a presentation on single sided deafness and some of the research he has been doing for the past five years. In the afternoon, we took the discussion to a patient-centered domain. After the patient has been implanted and fitted with their device, how do we know that they are receiving appropriate gain from the device? In other words, how is performance verified? We use different tools including aided sound-field thresholds and speech testing in quiet and noise, such as using the HINT and QuickSIN.

We also use qualitative measures, such as the APHAB and SSQ. These are all good measures, but how do we know which tool is the best? We might be just taking these measures from the hearing aid world and transplanting them into the bone-anchored world. Is that the best way to evaluate these patients? We are not sure, and we need more evidence. That was one thing that came out of the meeting.

We also had Bill Hodgetts from the University of Alberta in Edmonton talk about some of the work that he's been doing in verification and why verification is so important in the fitting of bone-anchored devices. He shared some of the developments that are taking place in that area.

We also had the group talk about what they would like to see in these devices in the near future and how the solution should evolve. Right now we have a solution that is percutaneous, meaning that the implant is in the skull, but the processor is located on the outside of the skin. The abutment fits through the skin and attaches to the processor. There are skin issues that can result that audiologists sometimes have to deal with. We asked if they would like to see a completely implantable hearing system where everything is under the skin and in the bone. Most attendees would like to see a completely implantable hearing system but some expressed concerns about its long term efficacy and safety.

There was a consensus that everyone is doing things differently, that there is no standard or reference as to how patients, adults and children, should be evaluated preoperatively and postoperatively or how performance should be verified.

Everyone recognizes the need for a best-practice guideline. If we are to develop a best-practice guideline, the guideline has to be driven by the audiologic community and a professional association such as the American Academy of Audiology (AAA). The industry should not be the driver of certain issues.

SMAKA: Right. And will that happen?

SOCKALINGAM: Yes, the process has begun. Michael Valente approached AAA and the Academy has decided to move this forward by setting up a Task Force chaired by Dr. Valente. The Board at AAA will ask the Chair to appoint about ten stakeholders to the Task Force who will then work on developing a Best-Practice Guideline for bone-anchored solutions. There is a hope that there will be a guideline for adults and another one for children. These guidelines will be peer-reviewed;the guidelines will go through an internal review within AAA and then through an external review involving the membership of AAA. Once those guidelines have been reviewed and approved, they will be published as AAA guidelines. That process has been initiated;we are fortunate to have AAA take it to the next stage.

SMAKA: Can you tell me what you heard anecdotally from the audiologists who attended?

SOCKALINGAM: One thing we heard was that the audiologists were happy we held this forum because it was not about promoting a product, even though Oticon Medical was the organizer of the meeting. It wasn't about the Oticon Medical Ponto hearing system;it was about advancing the profession by giving audiologists the requisite tools and knowledge to better serve their patients. The attendees were very positive and said that now that we have started the discussion, it seems that having a Best Practice Guideline is possible in the near future.

We received feedback as part of the continuing education course. The unanimous verdict was that the attendees were very pleased with the meeting. The attendees thought the meeting was clinically relevant and they were looking forward to having more meetings like this in the future. They said we should have a meeting like this once a year to review the progress of the Best Practice Guideline and share experiences across clinics. If a Best Practice Guideline is available, it can be adapted for different settings. That is one thing the attendees wanted to see as well. They felt that the guidelines will provide them with a framework to do a better job with their patients.

SMAKA: Have the participants been keeping in touch after the meeting, through a message board, conference call or other means?

SOCKALINGAM: There has to be continued discussion and we recognize that. We can't just bring people together once, pick their brains, and then say, "Okay, that was great. Thank you very much." We cannot forget the people who came together and helped bring this to fruition, and I think they would also very much like to stay in contact with one another for peer support.

We are currently working on a project to facilitate continued discussion between audiologists and the industry as well on these important topics. We need feedback from all of the stakeholders to do a better job in advancing technology for our patients, and they need to continue to share their experiences with other colleagues.

SMAKA: Do you have plans for a meeting next year?

SOCKALINGAM: Yes, we do have a plan. One of the questions that evolved in every discussion we had was, "Where is the evidence?" We absolutely need more evidence before we can adopt anything. If you review the research in bone-anchored solutions, there are several papers published, but the majority of the papers are based on very small sample sizes and on methodologies that may be questionable.

We need high quality studies. In fact, a systematic review of the research completed by a group in the United Kingdom has shown that the data is weak. We need better quality studies, more evidence, particularly in the area of single-sided deafness. We are continuing with research in this area, with opinion leaders, academics, and clinicians across the country.

When we bring this group together again we would also like to update them on what current evidence is out there, along with a discussion on several issues in this area that we haven't touched on and need to continue to discuss.

One of the areas that was discussed was reimbursement. I think you would agree that it's a major topic on everyone's list. Question number 10 on the questionnaire we sent out was about reimbursement, but we unfortunately never had enough time to find out from the group how they all handle reimbursement. That will definitely be a point of discussion in the future.

Although there is a lot of work still to be done, this forum brought many important issues to light, and some great things came out of it that will continue to move the field forward.

SMAKA: Thanks for your time, Ravi. We definitely look forward to hearing more about the work of the new task force. It would be great to catch up with you later this year and hear how that's coming along.

SOCKALINGAM: Yes, that would be great. Thanks, Carolyn.

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ravi sockalingam

Ravi Sockalingam, PhD

Director of Clinical Research and Professional Relations, Oticon Medical

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