Published: October 14, 2014

The Food and Drug Administration’s Role in the Safe Use of Medical Devices: Why Otolaryngologists’ Input Is Imperative

Anjum Khan, MD, MPH Medical Officer, Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation, CDRH, FDA Adjunct Clinical Associate Professor of Surgery, Uniformed Services University, Bethesda, MD Marilyn Neder Flack, MA Executive Director, AAMI Foundation at AAMI, Silver Spring, MD Rahul Shah, MD, Associate Professor of Otolaryngology and Pediatrics, Children’s National Medical Center and George Washington University, Washington, DC; Member, ENT Device Advisory Panel, FDA From the AAO-HNS Medical Devices and Drugs Committee Committee Chair and Series Editor: Anand K. Devaiah, MD Associate Professor, Departments of Otolaryngology, Neurological Surgery, and Ophthalmology Boston University School of Medicine and Boston Medical Center Introduction As scientific and technological advances enhance the pace of medical device1 innovation, there is increasing reliance on medical devices for patient care. Otolaryngologists, who may work in settings such as outpatient, emergency, surgical, and/or nursing home care, use a wide variety of devices for diagnosis, mitigation, and treatment of medical conditions for their patients. The inaugural article in this series for the Bulletin introduced the basic concepts of how the Food and Drug Administration (FDA) functions in regulating devices and drugs. Having a more in-depth understanding of the FDA, and how it works to ensure the safety and effectiveness of medical devices used by otolaryngologists in the above care settings is important. It enables otolaryngologists to know how they may play an active role in protecting the safety of their own patients, and in contributing to the nation’s public health related to medical devices. As discussed in two-part article, one critical role otolaryngologists can play in assisting FDA in its mission to protect and promote the public health is that of an “active reporter”of problems they encounter with actual clinical use of medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing pre-market applications for medical devices to ensure that the devices meet the regulatory requirement of a reasonable assurance of safety and effectiveness. CDRH utilizes both pre-market programs to review device information prior to permitting manufacturers to legally market medical devices, and post-market programs to perform surveillance of device performance once it is in widespread clinical use. It also has research, compliance, and educational components that round out the Center’s efforts to protect and promote the public health with respect to medical devices. The focus of this two-part article is on the pre-market and post-market work conducted by CDRH, and how otolaryngologists can contribute to ensuring and optimizing medical device safety for their patients. (Part 2) Post-market Surveillance No device is risk free, regardless of the level of pre-market review prior to marketing the device in the broad clinical community. Rare, yet potentially serious safety problems, a significant rise in anticipated risks, design problems, quality issues, and manufacturing problems may occur once any device is in widespread use. These post-market issues may occur regardless of regulatory class and whether or not the device underwent pre-market clinical testing. This may be explained, at least in part, because conditions of use during the clinical trial phase for Class III devices (and for the Class II devices for which clinical data were also necessary) may differ from routine clinical use following FDA clearance or approval. For example, in a clinical study, the device is often used by highly trained and experienced physicians, in a limited number of study sites, and in a relatively small population that is well defined. However, once these devices are legally marketed in the U.S., the device is available for use by physicians with a wider range of training and experience. Hence, it may be used in a wider patient population, and the post-market clinical performance of the device may differ from that observed in clinical trial(s) with the device. Timely reporting by device users of problems associated with medical devices in clinical use in the post-market setting is therefore critical for both manufacturers and CDRH to protect the public health (i.e., monitor device performance to identify and promptly address actual and potential safety issues). Once the devices are on the market, CDRH learns of problems from several sources. This is often through adverse event reports received from physicians, nurses, and consumers who experience problems. However, the reports from physicians and other users of various devices often lack sufficient detail or pertinent clinical information. This makes interpretation of the event and its significance more difficult. Otolaryngologists can play a key role in protecting the health and safety of their own patients, as well as the patients they will never see, by collaborating with CDRH through reporting device problems. This should be to both the medical device manufacturers and the CDRH. For example, it is important to report device problems that resulted in harm to the user and/or the patient, or could have caused harm if intervention did not occur. Providing as much detail as possible regarding the procedure in which the device was used, any device identifiers, and the nature of the device problem from the clinician’s perspective is vitally important. Such information permits CDRH to better evaluate the issue and take appropriate action if necessary. Otolaryngologists are highly encouraged to use the FDA’s MedWatch voluntary program to report any device problems they encounter that have or could affect their patients’safety. Reports may be submitted in several ways. To access the on-line and paper forms (FDA Form 3500), please visit https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm6. You may choose to include your name or submit the information anonymously. However, it is helpful when contact information is provided. FDA analysts may need to contact you to discuss the report. Your identity is never released to the public, even if you include your name in the report. Alternatively, you may access the recently launched mobile application, Medwatcher, to report using your phone or tablet. This is a new and convenient way to report problems with devices and other FDA regulated medical products. This method is easy and permits you to upload pictures of the device problem you are reporting. You may access this new application at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm7. When CDRH receives a report, the post-market analyst may review the issue in a variety of ways, depending on the reported problem: Researching previously reported events to identify patterns associated with the product; Contacting the device manufacturer for its evaluation of the problem; Talking with clinical users of the product to gain their perspective; and Reviewing the literature concerning the product and specific reported issue The analyst may consider many factors that could have caused or contributed to the event. These could include failures resulting from design, quality, manufacturing problems, human factor issues, and adverse device interactions (e.g., electromagnetic interference from one device to another). Based on the findings, the analyst may determine that the issue should be monitored over time, or may decide that action is needed. Actions can be in conjunction with other offices within CDRH, and can include interactions with the manufacturer.  They work with manufacturers in different ways: addressing labeling concerns, performing facility inspections, sending warning letters, issuing device recalls, creating requirements for post-market studies, sending “Safety Alerts”to healthcare professionals and consumers, authoring peer and non-peer reviewed articles, updating relevant websites, producing informative webcasts, conducting public workshops, and forming partnerships with device user organizations.8 Examples of some regulatory actions for otolaryngologic devices can be viewed on CDRH’s searchable database of all device recalls by entering the relevant information, such as device or manufacturer’s name. 9 An example of targeted communications to consumers and healthcare professionals, to inform them how to use devices safely, is the recent communication to consumers about the use of neti pots for rinsing nasal passages. 10 This communication resulted from several post-market reports of improper use of neti pots that may have caused or contributed to two deaths from a rare brain infection in 2011. The Louisiana State Health Department linked the infections to tap water contaminated with an amoeba called Naegleria fowleri that may have been introduced into the nose via neti pots. In summary, otolaryngology is a complex, multifaceted surgical specialty that touches every part of the patient care experience including outpatient, emergency care, surgery, and nursing homes.  Furthermore, our specialty has a history, present, and future of innovation that is necessary to provide cutting-edge care to patients. As such, we are especially vulnerable to issues with medical devices and products. This primer, written in conjunction between otolaryngologists and the FDA will hopefully draw attention to the significant role both groups have in medical device safety and surveillance. Physicians are encouraged to report events not only to the manufacturer, but also to CDRH. Many types of device problems occur intermittently. For this reason, large macro-level databases that are needed to rapidly identify trends in issues with a particular device.  The onus lies with us to immediately and consistently report issues with devices we encounter. This allows the FDA to aggregate individual issues into meaningful, actionable data. References    Medwatch Program https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm(Last accessed on 11-25-13).    Med watcher Mobile Application http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm (Last accessed on 11-25-13).    Post-market Analyst Actions Flack, Marilyn; Gross, Thomas P.; and Samuels-Reid, Joy, et. al., “FDA Working to Ensure the Safety of Medical Devices used in the Pediatric Population,”pg. 1358, from, Pediatric Clinics of North America, December 2012, Editors Jacobs, Brian and Coppes, Max.    Recalls http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm295488.htm. (Last accessed on 11-25-13).    Consumer Updates http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm316375.htm (Last accessed on 11-25-13). This is another in a series of articles being produced by the Medical Devices and Drugs Committee, written by committee members, consultants, and invited guests for the AAO-HNS membership. Do you have a question or topic we can address, which may fall under the committee’s charge? Do you have a comment about an article? Please let us know! Send an email to our coordinator, Harrison Peery at hpeery@entnet.org and the chair, Anand Devaiah, MD, at anand.devaiah@bmc.org, with the subject line “MDDC question/article”so we can properly identify and answer your query. We strive to quickly answer our “fan mail.”Thanks in advance for your note, and helping to make sure we catch your email floating within the “Spamiverse.”Please note that we will ask your permission to publish your note, in anonymous or edited form, if it becomes the inspiration for a Bulletin article.

Anjum Khan, MD, MPH
Medical Officer, Division of Ophthalmic and Ear, Nose, and Throat Devices
Office of Device Evaluation, CDRH, FDA
Adjunct Clinical Associate Professor of Surgery, Uniformed Services University, Bethesda, MD

Marilyn Neder Flack, MA
Executive Director, AAMI Foundation at AAMI, Silver Spring, MD

Rahul Shah, MD, Associate Professor of Otolaryngology and Pediatrics, Children’s National Medical Center and George Washington University, Washington, DC; Member, ENT Device Advisory Panel, FDA

From the AAO-HNS Medical Devices and Drugs Committee
Committee Chair and Series Editor: Anand K. Devaiah, MD
Associate Professor, Departments of Otolaryngology, Neurological Surgery, and Ophthalmology
Boston University School of Medicine and Boston Medical Center

Introduction

As scientific and technological advances enhance the pace of medical device1 innovation, there is increasing reliance on medical devices for patient care. Otolaryngologists, who may work in settings such as outpatient, emergency, surgical, and/or nursing home care, use a wide variety of devices for diagnosis, mitigation, and treatment of medical conditions for their patients.

The inaugural article in this series for the Bulletin introduced the basic concepts of how the Food and Drug Administration (FDA) functions in regulating devices and drugs. Having a more in-depth understanding of the FDA, and how it works to ensure the safety and effectiveness of medical devices used by otolaryngologists in the above care settings is important. It enables otolaryngologists to know how they may play an active role in protecting the safety of their own patients, and in contributing to the nation’s public health related to medical devices. As discussed in two-part article, one critical role otolaryngologists can play in assisting FDA in its mission to protect and promote the public health is that of an “active reporter”of problems they encounter with actual clinical use of medical devices.

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing pre-market applications for medical devices to ensure that the devices meet the regulatory requirement of a reasonable assurance of safety and effectiveness. CDRH utilizes both pre-market programs to review device information prior to permitting manufacturers to legally market medical devices, and post-market programs to perform surveillance of device performance once it is in widespread clinical use. It also has research, compliance, and educational components that round out the Center’s efforts to protect and promote the public health with respect to medical devices. The focus of this two-part article is on the pre-market and post-market work conducted by CDRH, and how otolaryngologists can contribute to ensuring and optimizing medical device safety for their patients.

(Part 2)
Post-market Surveillance

No device is risk free, regardless of the level of pre-market review prior to marketing the device in the broad clinical community. Rare, yet potentially serious safety problems, a significant rise in anticipated risks, design problems, quality issues, and manufacturing problems may occur once any device is in widespread use. These post-market issues may occur regardless of regulatory class and whether or not the device underwent pre-market clinical testing. This may be explained, at least in part, because conditions of use during the clinical trial phase for Class III devices (and for the Class II devices for which clinical data were also necessary) may differ from routine clinical use following FDA clearance or approval. For example, in a clinical study, the device is often used by highly trained and experienced physicians, in a limited number of study sites, and in a relatively small population that is well defined. However, once these devices are legally marketed in the U.S., the device is available for use by physicians with a wider range of training and experience. Hence, it may be used in a wider patient population, and the post-market clinical performance of the device may differ from that observed in clinical trial(s) with the device. Timely reporting by device users of problems associated with medical devices in clinical use in the post-market setting is therefore critical for both manufacturers and CDRH to protect the public health (i.e., monitor device performance to identify and promptly address actual and potential safety issues).

Once the devices are on the market, CDRH learns of problems from several sources. This is often through adverse event reports received from physicians, nurses, and consumers who experience problems. However, the reports from physicians and other users of various devices often lack sufficient detail or pertinent clinical information. This makes interpretation of the event and its significance more difficult.

Otolaryngologists can play a key role in protecting the health and safety of their own patients, as well as the patients they will never see, by collaborating with CDRH through reporting device problems. This should be to both the medical device manufacturers and the CDRH. For example, it is important to report device problems that resulted in harm to the user and/or the patient, or could have caused harm if intervention did not occur. Providing as much detail as possible regarding the procedure in which the device was used, any device identifiers, and the nature of the device problem from the clinician’s perspective is vitally important. Such information permits CDRH to better evaluate the issue and take appropriate action if necessary.

Otolaryngologists are highly encouraged to use the FDA’s MedWatch voluntary program to report any device problems they encounter that have or could affect their patients’safety. Reports may be submitted in several ways. To access the on-line and paper forms (FDA Form 3500), please visit https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm6.

You may choose to include your name or submit the information anonymously. However, it is helpful when contact information is provided. FDA analysts may need to contact you to discuss the report. Your identity is never released to the public, even if you include your name in the report.

Alternatively, you may access the recently launched mobile application, Medwatcher, to report using your phone or tablet. This is a new and convenient way to report problems with devices and other FDA regulated medical products. This method is easy and permits you to upload pictures of the device problem you are reporting. You may access this new application at http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/ucm348271.htm7.

When CDRH receives a report, the post-market analyst may review the issue in a variety of ways, depending on the reported problem:

  • Researching previously reported events to identify patterns associated with the product;
  • Contacting the device manufacturer for its evaluation of the problem;
  • Talking with clinical users of the product to gain their perspective; and
  • Reviewing the literature concerning the product and specific reported issue

The analyst may consider many factors that could have caused or contributed to the event. These could include failures resulting from design, quality, manufacturing problems, human factor issues, and adverse device interactions (e.g., electromagnetic interference from one device to another).

Based on the findings, the analyst may determine that the issue should be monitored over time, or may decide that action is needed. Actions can be in conjunction with other offices within CDRH, and can include interactions with the manufacturer.  They work with manufacturers in different ways: addressing labeling concerns, performing facility inspections, sending warning letters, issuing device recalls, creating requirements for post-market studies, sending “Safety Alerts”to healthcare professionals and consumers, authoring peer and non-peer reviewed articles, updating relevant websites, producing informative webcasts, conducting public workshops, and forming partnerships with device user organizations.8

Examples of some regulatory actions for otolaryngologic devices can be viewed on CDRH’s searchable database of all device recalls by entering the relevant information, such as device or manufacturer’s name. 9 An example of targeted communications to consumers and healthcare professionals, to inform them how to use devices safely, is the recent communication to consumers about the use of neti pots for rinsing nasal passages. 10 This communication resulted from several post-market reports of improper use of neti pots that may have caused or contributed to two deaths from a rare brain infection in 2011. The Louisiana State Health Department linked the infections to tap water contaminated with an amoeba called Naegleria fowleri that may have been introduced into the nose via neti pots.

In summary, otolaryngology is a complex, multifaceted surgical specialty that touches every part of the patient care experience including outpatient, emergency care, surgery, and nursing homes.  Furthermore, our specialty has a history, present, and future of innovation that is necessary to provide cutting-edge care to patients. As such, we are especially vulnerable to issues with medical devices and products. This primer, written in conjunction between otolaryngologists and the FDA will hopefully draw attention to the significant role both groups have in medical device safety and surveillance. Physicians are encouraged to report events not only to the manufacturer, but also to CDRH. Many types of device problems occur intermittently. For this reason, large macro-level databases that are needed to rapidly identify trends in issues with a particular device.  The onus lies with us to immediately and consistently report issues with devices we encounter. This allows the FDA to aggregate individual issues into meaningful, actionable data.

References

This is another in a series of articles being produced by the Medical Devices and Drugs Committee, written by committee members, consultants, and invited guests for the AAO-HNS membership. Do you have a question or topic we can address, which may fall under the committee’s charge? Do you have a comment about an article? Please let us know! Send an email to our coordinator, Harrison Peery at hpeery@entnet.org and the chair, Anand Devaiah, MD, at anand.devaiah@bmc.org, with the subject line “MDDC question/article”so we can properly identify and answer your query. We strive to quickly answer our “fan mail.”Thanks in advance for your note, and helping to make sure we catch your email floating within the “Spamiverse.”Please note that we will ask your permission to publish your note, in anonymous or edited form, if it becomes the inspiration for a Bulletin article.
More from October 2014 – Vol. 33 No. 10
Oct2014_AOA
Association of Otolaryngology Administrators
Eugene N. Myers, MD, presenting a proclamation from AAO-HNS to Prof. Virgilijus Ulozas, president of the sixth Baltic Congress.
Sixth Baltic Congress, Kaunas, Lithuania – EXTENDED ONLINE VERSION
Eugene N. Myers, MD, FACS, FRCS, Edin (Hon) Distinguished professor emeritus, University of Pittsburgh School of Medicine It was a privilege to be invited to the sixth Baltic ENT Congress in Kaunas, the second largest city in Lithuania, May 22- 24 of this year. Ten years have passed since the Baltic ENT Congress was last in Lithuania. The congress president, Prof. Virgilijus Ulozas, MD, head of the department of otolaryngology, Lithuanian University of Health Sciences, said, “This meeting will offer otolaryngologists from Lithuania, Latvia, Estonia, and other countries ideal opportunities to pursue continuing medical education, to learn about recent achievements and likely future developments, and exchange scientific ideas and experiences in our field.” The organizers prepared a scientific feast with important foreign and national speakers. The meeting was in English. There were 283 registrants from 11 countries besides the Baltic States including Australia, the Czech Republic, Denmark, Poland, South Korea, Turkey, the United Kingdom, and the United States. There was strong support from four sponsors and nine exhibitors. The excellent scientific sessions included 81 oral presentations in 10 scientific sessions, as well as 20 posters and a cochlear implant satellite symposium. I had the privilege of giving a keynote lecture on “The Changing Role of the Surgeon in the Management of Cancer of the Head and Neck”and chaired the panel on oncology. One of the program highlights was Prof. Ulozas’lecture titled “Intercellular Communication between Laryngeal Carcinoma Cells via Membranous Tunneling Nanotubes,”which provided new insights into the behavior of squamous cell carcinoma of the larynx at the cellular level. The opening ceremony featured beautiful songs by the choir “Neres,”whose singers are from the Lithuania University of Health Sciences, Kaunas. An elaborate welcoming party followed in the Park Inn, and the last evening ended with a gala dinner at the Zalgiris Arena, the focal point for basketball in Kaunas. Interestingly, the favorite sport of the Lithuanian people, who tend to be rather tall, is basketball. In fact, many NBA players are from Lithuania. All in all, it was a wonderful opportunity to visit Lithuania for the first time, learning from Lithuanian doctors about their country and about interesting scientific facts. For those who have not visited Lithuania, I can highly recommend it.
Team evaluation of a clinic patient during surgical screening. Left to right: Jeffrey Watson, MD, Russell Kridel, MD, J. Charlie Finn, MD.
FACE TO FACE: Quetzaltenango, Guatemala – EXTENDED ONLINE VERSION
Jeffrey B. Watson, MD, University of California, San Diego, Humanitarian Travel Grant Awardee In October 2013, I had the privilege of joining a team of facial plastic surgeons to help the people of Quetzaltenango, Guatemala, on a medical mission sponsored by the AAFPRS FACE TO FACE and FINN Foundations. The team was led by J. Charlie Finn, MD, accompanied by Russell Kridel, MD; Scott Stephan, MD; Ryan Brown, MD; Vanderbilt resident Ross Shockley, MD; and a support staff. We journeyed through Guatemala’s mountainous terrain, climbing through the beautiful city of Antigua to our final destination of Quetzaltenango. Situated 7,655 feet above sea level, Quetzaltenango is in a mountain valley with numerous small villages surrounding it. Despite the natural beauty and tremendous biodiversity that is evident all throughout Guatemala, it remains one of the poorest countries in Latin America. The local Quiche and Ladino people of Quetzaltenango tragically remain plagued by poor access to medical and surgical care. Dozens of patients and their families had gathered at the Sanatorio Senda de Vida Clinic and we saw 110 patients the first day with a wide range of pathology including microtia, cleft lip and palate, craniofacial anomalies, nasal deformities, and scar contractures from burns and trauma. Numerous patients were also seen in follow-up who had received care from the team the year prior. In total, we performed 42 reconstructive surgeries during the following four days, addressing the diverse needs of our patients The opportunity to work with this dedicated team of surgeons has reaffirmed my lifelong commitment to serve the less fortunate and I look forward to returning to Quetzaltenango this month to continue our mission. I am greatly indebted to the AAO-HNSF Humanitarian Efforts Committee for their support that made my participation possible.
07_Kevin-with-mother-of-patient_2
Armenia’s First Bone-anchored Hearing Device – EXTENDED ONLINE VERSION
Kevin A. Peng, MD Resident Physician, department of head and neck surgery, University of California, Los Angeles (UCLA) The Yerevan airport felt much like any other, except that the line to clear immigrations and customs was blissfully short. I was greeted by Salpy Akaragian, RN, MN, FIAN, a UCLA nursing administrator who, along with Akira Ishiyama, MD, the senior neurotologist at UCLA, spearheaded the first efforts to bring cochlear implantation and advanced otologic care to Armenia in late August and early September of last year. In its current incarnation, the Republic Armenia is young—22 years old. Its capital, Yerevan, is a refreshing mix of new and old. We woke at 5:30 am and after breakfast, were whisked to Erebuni Medical Center, where our patients were waiting. As they were taken to the operating room, we consulted on a string of otologic patients: otosclerosis, deafness, after neonatal meningitis, and EVA syndrome. Dr. Ishiyama scrubbed to supervise and assist Artur Shukuryan, MD, chair of the department of otorhinolaryngology at the Yerevan State Medical University (YSMU), as well as Vigen Bakhshinyan, MD, a former YSMU resident. Some things were familiar: the scrubbing, the draping, and the hair clipping. Others were not: the plastic microscope drape was washed between cases and reused. Instrument sterilization occurred on a small back burner in the kitchen area of the operating suite, right next to the electric coffeepot. We initially performed two cochlear implants. The following day, three cochlear implant devices and two bone-anchored hearing (BAHA) devices finally cleared customs, and we rushed to the hospital. The patients, who had been on-call for surgery pending delivery of the devices, arrived before us. Drs. Ishiyama and Bakhshinyan performed cochlear implants, while I performed BAHA implants with the assistance of Dr. Shukuryan. These were the first two BAHA devices ever implanted in Armenia. I left postoperative care instructions for the three audiologists, who had been trained in Moscow and had previous experience with the BAHA system. The trip made several lasting impressions. Although the facilities were relatively antiquated and the resources generally limited, they were sufficient to provide state-of-the-art otologic care. The camaraderie between patients’families and the physicians was impressive—all were on a first-name basis, even with the chair of the department! Finally, the devotion the patients’families displayed was truly remarkable.
2014 AAO-HNS Election Results
We are appreciative of all the work of the Nominating Committee to present the membership with the outstanding slate of candidates from which to choose. This is an important and difficult task with which it is charged, particularly when drawing from such an incredibly talented pool of Members. It deserves our recognition and appreciation. Members of the Committee are: Drs. James Netterville (chair), Peter Abramson, Ellen Deutsch, Howard Francis, Gady Har-El, Brian Nussenbaum, Shannon Pryor, Cecelia Schmalbach, Ashley Wackym, and Ken Yanagisawa. Lauren Zaretsky, MD, chair of the Ethics Committee serves as an ex-officio member of the committee. We also extend our greatest appreciation to all the candidates for their willingness to run for office and serve the AAO-HNS and its members. You are all dedicated members and you are greatly appreciated. Election Results President-Elect Sujana S. Chandrasekhar, MD Secretary-Treasurer Elect Scott P. Stringer, MD, MS Director-at-Large (Academic) Carol R. Bradford, MD Director-at-Large (Private Practice) Jay S. Youngerman, MD Audit Committee Kenneth W. Altman, MD, PhD Nominating Committee (Academic) Stacey L. Ishman, MD, MPH Albert L. Merati, MD Nominating Committee (Private Practice) Brian A. Moore, MD Lawrence M. Simon, MD
What Do You Know? That’s a Good Question…
Mark K. Wax, MD Lifelong learning is a fundamental part of being a good physician. From the start of our education we seek the best way to improve patient care. Upon entering medical school, we see that in order to keep up with the rapid expansion of medical knowledge, a good set of learning skills will be necessary, if we wish to provide the best care to our patients. It is estimated that knowledge in medicine doubles every eight years. While some of this is at a basic science level that could one day offer insights and improved understanding of diseases, some immediately influence the care we offer. Addressing the question of how to keep up with this expansion of knowledge has many facets. The AAO-HNSF addresses the issue of lifelong learning in a number ways. Whether it is by online education activities or at national meetings, a fundamental part of learning is to measure how that knowledge has been absorbed and understood. This is usually done through a series of pre- and post-tests. As part of this process of evaluating knowledge, competence, and performance, the Foundation has developed a healthy question bank. In fact, these questions are used for a multitude of education purposes. While they are most often used to test for acquired knowledge from an academic exercise, they can also be used to detect weakness in competence and provide a direction for future study. An interesting side benefit is that the process of developing questions is a learning exercise in itself. In order to develop an effective question, the developers must be familiar with the subject. They must not only have the correct knowledge, but also be aware of subtleties of incorrect information that separates the individual who has learned and understands the material from someone who has not. They must evaluate current literature and look for biases in reporting. All questions require a reference and a justification for why the correct choice is, in fact, correct. Questions are developed in many forums. One of the earliest of these was the Academic Bowl. This competition takes place at the Annual Meeting & OTO EXPOSM. Four teams of residents are chosen from residency programs around the country that participate in the Home Study Course (HSC). Those programs with the highest performers are chosen and they then compete for a variety of prizes. There are eight committees of more than 230 members that contribute to writing these questions. They develop questions for a variety of other education products also: Home Study Course, Online Courses and Lectures, and AcademyQ™. Questions are vetted through subject matter experts and then double-checked with committee chairs. The creation of a good question turns out to be an excellent education experience for not only the individuals testing their knowledge, but for a larger group of individuals involved in the process. Collection of the questions also allows the Academy to have a robust and constantly updated bank for members to use for professional development. Question development is one avenue of lifelong learning that benefits many. Just in time learning is projected to be the wave of the future and this is a method of preparing for that future.
Clinical Consensus Statement: Pediatric Chronic Rhinosinusitis
Scott E. Brietzke, MD, MPH; Jennifer J. Shin, MD, SM; Sukgi Choi, MD; Jivianne T. Lee, MD; Sanjay R. Parikh, MD; Maria Pena, MD; Jeremy D. Prager, MD; Hassan Ramadan, MD; Maria Veling, MD; Maureen Corrigan; Richard M. Rosenfeld, MD, MPH This month, the AAO-HNSF publishes its latest clinical consensus statement on Pediatric Chronic Rhinosinusitis in Otolaryngology–Head and Neck Surgery. Pediatric chronic rhinosinusitis (PCRS) is a commonly encountered condition in otolaryngological practice. Five percent to 13 percent of childhood viral upper respiratory tract infections may progress to acute rhinosinusitis,1-4 with a proportion of these progressing to a chronic condition. PCRS may also co-exist and/or be exacerbated by other widespread conditions such as allergic rhinitis and adenoid disease,5-9 and some suggest the incidence of PCRS may be rising.10 In addition, PCRS has a meaningful influence on quality of life,11 with its related adverse effects potentially exceeding that of chronic respiratory and arthritic disease.12 PRCS also has the potential to exacerbate asthma,13, 14 a condition which negatively affects 2 percent to 20 percent of children.15-17 In spite of its prevalence and influence on affected families, many aspects of PCRS remain ill defined. Nonetheless, PCRS occurs with sufficient frequency that otolaryngologists regularly encounter it in their practice, creating opportunities for optimizing practice patterns. While experience regarding the epidemiology, diagnosis, and management of PCRS is burgeoning, the associated evidence regarding optimal medical and surgical management has clear limits. The AAO-HNSF Guidelines Task Force therefore, selected this topic for clinical consensus statement (CCS) development. The expert panel convened with the objectives of addressing opportunities to promote appropriate care, reduce inappropriate variations in care, and educate and empower clinicians and patients toward the optimal management of PCRS. The final document describes the result of this process, and focuses on diagnosis, medical therapy, and surgical interventions. This consensus statement was developed using a modified Delphi method, a systematic approach to achieving consensus among a panel of topic experts. Initially designed by the RAND Corporation to better utilize group information in the 1950s, this methodology has been modified to accommodate advances in technology and is used widely to address evidence gaps in medicine and improve patient care without face-to-face interaction.18,19 Thirty-eight clinical statements were developed for assessment with the Delphi survey method. After two iterations of the Delphi survey, 22 statements (58 percent) met the standardized definition for consensus. Twelve clinical statements (31 percent) did not meet the criteria for consensus. Four clinical statements (11 percent) were omitted due to redundancy. The clinical statements were organized into four specific subject areas: Definition and diagnosis of PCRS Medical treatment of PCRS Adenoiditis/adenoidectomy Endoscopic sinus surgery/turbinoplasty. For the full listing of clinical statements, see the full text of the consensus statement at http://oto.sagepub.com/. References Clinical practice guideline: management of sinusitis. Pediatrics. 2001;108:798-808. Aitken M, Taylor JA. Prevalence of clinical sinusitis in young children followed up by primary care pediatricians. Arch Pediatr Adolesc Med. 1998;152(3):244-248. Ueda D, Yoto Y. The ten-day mark as a practical diagnostic approach for acute paranasal sinusitis in children. Pediatr Infect Dis J. 1996;15(7):576-579. Wald ER, Guerra N, Byers C. Upper respiratory tract infections in young children: duration of and frequency of complications. Pediatrics. 1991;87(2):129-133. Smart BA. The impact of allergic and nonallergic rhinitis on pediatric sinusitis. Cur Allergy Asthma Rep. 2006;6(3):221-227. Marseglia GL, Pagella F, Klersy C, et al. The 10-day mark is a good way to diagnose not only acute rhinosinusitis but also adenoiditis, as confirmed by endoscopy. Int J Pediatr Otorhinolaryngol. 2007;71(4):581-583. Tosca MA, Riccio AM, Marseglia GL, et al. Nasal endoscopy in asthmatic children: assessment of rhinosinusitis and adenoiditis incidence, correlations with cytology and microbiology. Clin Exp Allergy. 2001;31(4):609-615. Lee D, Rosenfeld RM. Adenoid bacteriology and sinonasal symptoms in children. Otolaryngol Head Neck Surg. 1997;116(3):301-307. Nguyen KL, Corbett ML, Garcia DP, et al. Chronic sinusitis among pediatric patients with chronic respiratory complaints. J Allergy Clin Immunol. 1993;92(6):824-830. Kim HJ, Jung Cho M, Lee J-W, et al. The relationship between anatomic variations of paranasal sinuses and chronic sinusitis in children. Acta Otolaryngol. 2006;126(10):1067-1072. Kay DJ, Rosenfeld RM. Quality of life for children with persistent sinonasal symptoms. Otolaryngol Head Neck Surg. 2003;128(1):17-26. Cunningham JM, Chiu EJ, Landgraf JM, et al. The health impact of chronic recurrent rhinosinusitis in children. Arch Otolaryngol Head Neck Surg. 2000;126(11):1363-1368. Smart BA, Slavin RG. Rhinosinusitis and pediatric asthma. Immunol Allergy Clin North Am. 2005;25(1):67-82. Rachelefsky GS, Katz RM, Siegel SC. Chronic sinus disease with associated reactive airway disease in children. Pediatrics. 1984;73(4):526-529. Larsson M, Hagerhed-Engman L, Sigsgaard T, et al. Incidence rates of asthma, rhinitis and eczema symptoms and influential factors in young children in Sweden. Acta Paediatr. 2008;97(9):1210-1215. Ronmark E, Perzanowski M, Platts-Mills T, et al. Incidence rates and risk factors for asthma among school children: a 2-year follow-up report from the obstructive lung disease in Northern Sweden (OLIN) studies. RespirMed. 2002;96:1006-1013. Ayres JG, Pansari S, Weller PH, et al. A high incidence of asthma and respiratory symptoms in 4-11 year old children. RespirMed. 1992;86(5):403-407. Vonk Noordegraaf A, Huirne JA, Brolmann HA, van Mechelen W, Anema JR. Multidisciplinary convalescence recommendations after gynaecological surgery: a modified Delphi method among experts. BJOG. Dec 2011;118(13):1557-1567. Dalkey NC. The Delphi Method: An Experimental Study of Group Opinion. Santa Monica: RAND Corporation;1969. RM-5888-PR.
CMS Proposes to Exclude Coverage of Osseointegrated Implants
Background On July 11, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule focusing on payment policy updates to the 2015 Durable Medical Equipment, Orthotics, Prosthetics and Supplies (DMEPOS) fee schedule. Notably, as part of the rule, CMS is proposing to clarify the scope of the Medicare coverage exclusion for hearing aids and withdraw coverage of all types of air conduction and bone conduction auditory prosthetics (external, internal, or implanted). If finalized, the proposed rule would negate CMS’current coverage of osseointegrated implants. CMS had expanded coverage to include osseointegrated implants as recently as 2005. In 2005, the auditory osseointegrated device was determined to be a new device category according to the new requirements for transitional pass-through payment during CMS’rulemaking. In the same regulatory revision, CMS additionally expanded coverage to both auditory osseointegrated devices and auditory brainstem devices, classifying them as prosthetic devices. In the past, CMS has traditionally addressed the scope of the Medicare hearing aid coverage exclusion through program instructions and national coverage policies or determinations. However, this year, CMS decided to clarify the definition and its coverage determination of a hearing aid in its proposed rulemaking and comment period for DMEPOS payment rates. CMS’ Rationale for its Proposed Coverage Exclusion In the proposed rule, CMS states that bone conduction auditory prosthetics (along with other devices classified as “hearing aids”) do not meet the statutory definition of a prosthetic device found at section 1861(s)(8) of the Social Security Act which, in part, states a “prosthetic devices (other than dental) which replace all or part of an internal body organ.”CMS also states that osseointegrated implants are, “bone conduction hearing aids that mechanically stimulate the cochlea; therefore, we believe that the hearing aid exclusion applies to these devices and propose that Medicare should not cover these devices, consistent with our interpretation of section 1862(a)(7) of the Act.”CMS additionally mentions in the rule that a National Coverage Determination (NCD) was issued for cochlear implant devices with, “…the result that this determination and recent requests to expand coverage of hearing devices raises serious questions about the intent and scope of the Medicare coverage exclusion for hearing aids.”CMS also claims it initiated its examination of its definition of a hearing aid after receiving multiple benefit category determination requests in recent years for the consideration of non-implanted, bone conduction hearing aid devices for single-sided deafness, as prosthetic devices under the Medicare benefit. Academy Advocacy Efforts In response to the proposed rule, Academy leadership and health policy staff advocated on multiple levels and engaged Academy committees, sister specialty societies and other leaders among our membership (within Otology/Neurotology as well as health policy and government affairs staff) to craft comments that best represent our members and our patients. More specifically, Academy leadership and staff conferenced individually and collectively with members and chairs of the Hearing and Implantable Hearing Devices Committees to gather specific examples and feedback on how the proposed rule, if enacted, would negatively impact thousands of patients who have no other recourse to better hearing. Further, the Academy participated in three direct meetings with CMS, various audiology and public interest group conferences, and meetings with presidents of ANS and AOS. All of these efforts were directed at raising awareness of the dangers of this proposed rule and garnering support in defense of our position. On September 2, 2014, the Academy, AOS, and ANS submitted a formal joint comment letter to CMS noting concerns about the proposal and providing a suggested alternative to the proposed rule that would allow for continued coverage of osseointegrated implants for Medicare patients. Our efforts will extend beyond the comment period as opportunities to positively influence any adverse CMS decision become evident. We will continue to closely monitor the matter and will be sure to keep members apprised of pertinent information via the eNews, HP Update, website, and other outreach tools. Members are encouraged to regularly check the Get Involved Regulatory Advocacy page for important announcements and opportunities to positively effect change. The Regulatory Advocacy page is at http://www.entnet.org/content/regulatory-advocacy. For the Academy leaders and members that took time out of your offices on short notice, or interrupted your vacations to personally participate in the aforementioned meetings and conferences, thank you. We greatly appreciate your dedication and willingness to get involved with these important policies.
Attending work hours?!
Rahul K. Shah, MD, George Washington University School of Medicine, Children’s National Medical Center, Washington, DC Over two decades ago, the concept of intern and resident work hours was novel and in many circles met with disbelief and impetuousness. Fast forward to 2014 and our interns, residents, and fellows have work hours. This begs the question—what do we all anticipate will happen in the next two decades? Academy member Scott Schoem co-authored a provocative and perhaps prescient article on what the future holds for attendings, our work hours, and our associated liability. What is great about Dr. Schoem’s perspective is the reality in the clinical scenarios he describes and the financial implications and pressures that attending surgeons face. This is all too well known to many of us; however probably not as well known to our patients, regulators, and insurers. Many countries and even here in the United States, some jurisdictions, have limits on the age that a physician can take call and some even limit the age an individual can be on the medical staff. The legalities of such are beyond my expertise, but we all know that a physical decline does come with aging. As such, the points raised by our colleagues about the inevitable examination of attending work hours is well stated. As they note in their article, there are work hour regulations for anesthesiologists after an on-call night, but not specifically for surgeons or other attendings. The concomitant reduction in resident work hours has resulted in a huge administrative burden being placed and transferred to the surgeon; furthermore the electronic medical record has reduced potentially the need for some administrative staff, with the attending surgeon completing “everything”electronically. That may sound great for a policy-maker, but for the surgeon—it is not great, having to document and chart the entire care delivery spectrum from office visit to billing is a large task that has been shifted over to the attending surgeon in the guise of efficient electronic documentation. As such, we are seeing the same number of patients, but taking almost twice as long!  Whereas previously there was availability of trainees to assist in such duties, they are often times post-call or cross-covering. The concept of surgeon fatigue is magnified for the vast majority of our Academy members who are in private practice.  In areas not served by academic medical centers or large community-based hospital systems, the emergency department or patients most likely depend on their surgeon to take the urgent cases to the operating room the next day and cannot afford to not have such occur (for the safety of the patient and the finances of the institution). Dr. Schoem and Dr. Christine Finck his co-author astutely note that what is needed is a cultural or paradigm shift towards an understanding of the limits of attending surgeons in practice. They certainly postulate some potential ways to handle the situation of surgeon fatigue when operating post-call with a long surgical list/case. However, until there is a broad cultural shift and acceptance of such a paradigm, real change will be elusive. We must implore our hospitals, state societies, and national organizations to recognize surgeon fatigue from the vantage point of an affected patient. The Joint Commission and others are very focused on the issue of sleep deprivation and there are many courses that help explain to surgeons the factors to look for and how to plow through sleep deprivation. Therein lies the problem, why are we accepting sleep deprivation and surgeon fatigue as a closed issue? As Dr. Schoem and Dr. Finck indicate, we need to think of novel solutions to this unique problem; the problem is magnified in the current era of trainee work hours and a huge increasing burden on attending surgeons in both private practice and academics.   References Schoem SR & Finck C. Time Out For Surgeons: When is the Attending Surgeon Too Tired? Volume 76(3) We encourage members to write us with any topic of interest and we will try to research and discuss the issue.  Members’ names are published only after they have been contacted directly by Academy staff and have given consent to the use of their names. Please email the Academy at qualityimprovement@entnet.org to engage us in a patient safety and quality discussion that is pertinent to your practice.
Academy Creates New Template Letters and Advocacy Statements to Aid Appeals
As members know, the Academy’s Health Policy team advocates on national socioeconomic issues impacting the membership at large in an effort to optimize reimbursement, mitigate adverse policy decisions, and improve relationships between members and payers both in the public and private sectors. While our primary focus is to address national issues, we also remain committed to providing members with the needed support to address issues that are more isolated at the local or state level, particularly if members across numerous states experience similar grievances, or if a policy runs counter to an Academy position, correct coding initiative, or the like. For example, after hearing from members experiencing denials from several payers of all claims of CPT 69210 and E/M services, the Academy sent letters to more than a dozen payers in more than 10 states urging reconsideration of these flawed policies. Similarly, the Academy has provided comments to more than 15 payers regarding their reimbursement policy on sinus ostial dilation as well as other state payers regarding reimbursement for the interpretation and performance of diagnostic imaging related to head and neck. While our efforts have yielded positive feedback from many, some payers continue to deny reimbursement for these services. The Academy remains dedicated to helping members address these burdensome denials. We have created three new template appeal letters and three new Academy advocacy statements to maximize the opportunity for positive results when members correspond with local payers. Specifically, we have created template appeal letters and advocacy statements for CPT 69210 and E/M services, Balloon Sinus Ostial Dilation, and Interpretation and Performance of Diagnostic Imaging by Otolaryngologists. It is the Academy’s hope that these member benefit resources will aid members who continue to experience denials following our national advocacy efforts. Take advantage of these Academy resources by visiting the Coding Corner at http://www.entnet.org/content/coding-corner.
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Hear What All the Tweeting Is About—Follow the Government Affairs Twitter Account – ONLINE EXCLUSIVE
Want to be one of the first to know what’s happening on Capitol Hill? If so, sign up for Twitter and follow the Government Affairs account @ AAOHNSGovtAffrs! You’ll receive daily updates on legislative and political issues impacting the specialty, your practice, and your patients. Get “insider”knowledge on matters such as repeal of the flawed Sustainable Growth Rate (SGR) formula, scope-of-practice battles, and Graduate Medical Education (GME) funding. Also, check out our Twitter scroll at www.entnet.org/advocacy for our latest tweets!
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ENT PAC – ONLINE EXCLUSIVE
As the November mid-term elections approach, educate and empower yourself by visiting www.entpac.org. ENT PAC, the political action committee of the AAO-HNS, financially supports federal Congressional candidates and incumbents who advance the issues important to otolaryngology–head and neck surgery. Since your AAO-HNS annual dues cannot be used for political purposes, ENT PAC was established to accept voluntary contributions enabling our members to speak with a collective voice. ENT PAC is a non-partisan, issue-driven entity that supplements the Academy’s legislative advocacy efforts and helps to increase the visibility of the specialty on Capitol Hill and with key policymakers. To learn more about ENT PAC and the Academy’s Federal Elections Center, visit our PAC website at www.entpac.org (log-in with your AAO-HNS Member ID and password) or email entpac@entnet.org for assistance.
Gearing Up for 2015 – ONLINE EXCLUSIVE
The AAO-HNS sincerely thanks its member-volunteer “state trackers” for their impressive efforts during the 2014 legislative session to effectively monitor legislative issues and trends important to the specialty, your practices, and your patients. However, it’s never too early to begin preparations for 2015! Join the growing team of AAO-HNS state trackers by emailing govtaffairs@entnet.org to receive daily or weekly legislative tracking updates in time for the 2015 sessions.
Key AMA Policy Changes Impacting Our Specialty—AMA Annual Meeting Re-Cap – ONLINE EXCLUSIVE
Liana Puscas, MD Chair, AAO-HNS Delegation to the AMA House of Delegates The American Medical Association (AMA) conducted its annual House of Delegates (HOD) meeting in Chicago, Illinois, from June 7-11, 2014. At the meeting, the AAO-HNS was represented by Liana Puscas, MD, MHS, delegation chair; Delegates Michael Goldrich, MD, and Shannon Pryor, MD; and Alternate Delegates Robert Puchalski, MD, and Academy EVP/CEO David R. Nielsen, MD. Joy Trimmer, JD, senior director of Government Affairs, and Danielle Jarchow, JD, health policy analyst provided staff support for the Delegation and OTO Section Council. Among the many items of business on the agenda affecting the general House of Medicine, the following issues are highlighted due to their potential influence on members of our Academy. Guidelines for Medical Healthcare Teams. The AMA’s Council on Medical Service presented its report regarding model healthcare teams and clearly delineated physician leadership of healthcare teams. Grace Periods under the ACA. Under the Affordable Care Act, patients enrolled in federal plans have a 90-day grace period for paying their premiums. During this time, care provided by a physician would not be covered if the patient does not pay the premiums that are in arrears. The AMA passed policy favoring advocacy in support of insurance company notifications of a patient’s grace period status upon eligibility verification by the physician. Health Insurance Formulary Transparency. The AMA supports legislation or regulation that ensures private health insurance carriers declare their formularies by October 1 of the preceding year. This would include information regarding generic versus trade formulations, copay responsibilities, and the inability to change a medication to a higher tier within the policy term. FDA Regulation of All Nicotine Products. The AMA passed resolutions opposing any FDA rule that exempts any nicotine-containing products, including e-cigarettes and cigars, from FDA regulation. Super Magnetic Toys. The AMA passed a resolution asking for a ban of neodymium magnetics whose magnetic strength index is greater than a certain threshold due to gastrointestinal and choking hazards produced by such toys. Restrictive Covenants. The AMA adopted a report opining that competition among physicians is ethically justifiable when based on factors such as quality of services, skill, experience, and conveniences offered to patients. Covenants aimed to reduce competition can disrupt continuity of care and limit access to care. Hospital Policies on Interactions with Industry. The HOD adopted a report by the Board of Trustees that encourages hospitals to craft policies concerning the relationships and interactions between hospital personnel and industry representatives within the hospital setting. Place of Service Code for Observation Services. In alignment with the Academy, the AMA continues to support advocacy with CMS to modify the rules that govern observation versus inpatient status. Many patients admitted for observation require the same level of care as those who are formally classified as inpatients, especially when that length of stay extends beyond a 24-hour period. Patients are often liable for services provided as part of observation care, and reimbursement is lower for observation status patients than inpatient status patients, even if the services provided by the physician are identical. Sunshine Act. The AMA website is prominently featuring information and guidelines for physicians during the tiered implementation of this Act. The next meeting of the AMA HOD is scheduled for November 8-11 in Dallas, Texas. As a reminder, since AMA delegations are in proportion to an organization’s number of AMA members, it is imperative that we continue to grow our AMA membership to maintain otolaryngology’s representation in the HOD. With questions regarding this report and other AMA House of Delegates activities, please email govtaffairs@entnet.org.
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Clinical Practice Guideline: Tinnitus Summary
David E. Tunkel, MD; Carol A. Bauer, MD; Gordon H. Sun, MD, MS; Richard M. Rosenfeld, MD, MPH; Sujana S. Chandrasekhar, MD; Eugene R. Cunningham Jr., MS; Sanford M. Archer, MD; Brian W. Blakely, MD, PhD; John M. Carter, MD; Evelyn C. Granieri, MD, MPH, MSEd; James A. Henry, PhD; Deena Hollingsworth, RN, MSN, FNP; Fawad A. Khan, MD; Scott Mitchell, JD, CPA; Ashkan Monfared, MD; Craig W. Newman, PhD; Folashade S. Omole, MD; C. Douglas Phillips, MD; Shannon K. Robinson, MD; Malcolm B. Taw, MD; Richard S. Tyler, PhD; Richard Waguespack, MD; Elizabeth J. Whamond This month, the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO–HNSF) will publish its latest clinical practice guideline, Tinnitus, as a supplement to Otolaryngology–Head and Neck Surgery. Recommendations developed address the evaluation of patients with tinnitus, including selection and timing of diagnostic testing and specialty referral to identify potential underlying treatable pathology, the evaluation and treatment of patients with persistent primary tinnitus, and the most appropriate interventions to improve symptoms and quality of life (QOL) for tinnitus sufferers. The guideline was developed using the a priori protocol outlined in the AAO–HNS Clinical Practice Guideline Development Manual.1 The complete manual is available at http://oto.sagepub.com/content/148/1_suppl/S1.full. To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. Recommendations in a guideline can only be implemented if they are clear and identifiable. This goal is best achieved by structuring the guideline around a series of key action statements, which are supported by amplifying text and action statement profiles. For ease of reference, only the statements and profiles are included in this brief summary. Please refer to the complete guideline for the important information in the amplifying text that further explains the supporting evidence and details of implementation for each key action statement. For more information about the AAO–HNSF’s other quality knowledge products (clinical practice guidelines and clinical consensus statements), our guideline development methodology, or to submit a topic for future guideline development, visit http://www.entnet.org/guidelines. Introduction Tinnitus is the perception of sound without an external source. More than 50 million people in the United States have reported experiencing tinnitus, resulting in an estimated prevalence of 10 percent to 15 percent in adults.2 About 20 percent of adults who experience tinnitus will require clinical intervention.3 Not a disease in and of itself, tinnitus is actually a symptom that can be associated with multiple causes and aggravating co-factors. Tinnitus is relatively common, but in rare cases it can be a symptom of serious disease such as vascular tumor or vestibular schwannoma (VS). Tinnitus can be persistent, bothersome, and costly. The prevalence of tinnitus was estimated in the National Health Interview Survey conducted in the United States in 1994 by asking whether individuals experienced “ringing, roaring, or buzzing in the ears that lasted for at least three months.”Such tinnitus was present in 1.6 percent of adults age 18-44 years, 4.6 percent of adults age 45-64 years, and 9.0 percent of adults age >60 years.4 In the Beaver Dam offspring study of more than 3,000 adults between the ages of 21 and 84 years studied between 2005 and 2008, 10.6 percent reported tinnitus of at least moderate severity or causing difficulty falling asleep.5 Tinnitus can also have a large economic impact. For example, tinnitus was the most prevalent service-connected disability for U.S. military veterans receiving compensation at the end of fiscal year 2012, resulting in nearly 1 million veterans receiving disability awards.6 Tinnitus can occur on one or both sides of the head and can be perceived as coming from within or outside the head. Tinnitus most often occurs in the setting of concomitant sensorineural hearing loss (SNHL), particularly among patients with bothersome tinnitus and no obvious ear pathology. The quality of tinnitus can also vary, with ringing, buzzing, clicking, pulsations, and other noises described by tinnitus patients. Additionally, the effects of tinnitus on health-related QOL vary widely, with most patients less severely affected but some experiencing anxiety, depression, and extreme life changes. Patients who have tinnitus accompanied by severe anxiety or depression require prompt identification and intervention, as suicide has been reported in tinnitus patients7 who have co-existing psychiatric illness. Most tinnitus is subjective, perceived only by the patient. In contrast, objective tinnitus can be perceived by others, is rare, and is not the focus of this guideline. The focus of this guideline is tinnitus that is bothersome and persistent (lasting six months or longer), often with a negative influence on the patient’s QOL. The guideline development group (GDG) chose six months as the criterion to define persistent tinnitus, since this duration is used most often as an entry threshold in published research studies on tinnitus. Some studies have used tinnitus of three months’duration for eligibility; it is possible that the recommendations of this clinical practice guideline (CPG) may be applicable to patients with tinnitus of shorter duration as well. As noted in Table 1, tinnitus should be classified as either primary or secondary. In this guideline, the following definitions are used: Primary tinnitus is used to describe tinnitus that is idiopathic and may or may not be associated with SNHL. While there is currently no cure for primary tinnitus, a wide range of therapies have been used and studied in an attempt to provide symptomatic relief. These therapies include education and counseling, auditory therapies that include hearing aids and specific forms of sound therapy, cognitive behavioral therapy (CBT), medications, dietary changes and supplements, acupuncture, and transcranial magnetic stimulation. Secondary tinnitus is tinnitus that is associated with a specific underlying cause (other than SNHL) or an identifiable organic condition. It is a symptom of a range of auditory and non-auditory system disorders that include simple cerumen impaction of the external auditory canal, middle ear diseases such as otosclerosis or Eustachian tube dysfunction, cochlear abnormalities such as Meniere’s disease, and auditory nerve pathology such as VS. Non-auditory system disorders that can cause tinnitus include vascular anomalies, myoclonus, and intracranial hypertension. Management of secondary tinnitus is targeted toward identification and treatment of the specific underlying condition, and is not the focus of this guideline. Despite the high prevalence of tinnitus and its potential significant influence on QOL, there are no evidence-based, multidisciplinary CPGs to assist clinicians with management. This guideline attempts to fill this void through actionable recommendations to improve the quality of care that tinnitus patients receive, based on current best research evidence and multidisciplinary consensus. The guideline recommendations will assist clinicians in managing patients with primary tinnitus, emphasizing interventions and therapies deemed beneficial, and avoiding those that are time-consuming, costly, and ineffective. Purpose The purpose of this guideline is to provide evidence-based recommendations for clinicians managing patients with tinnitus. The target audience is any clinician, including non-physicians, involved in managing these patients. Patients with tinnitus will often be evaluated by a variety of healthcare providers including primary care clinicians, specialty physicians, and non-physician providers such as audiologists and mental health professionals. The target patient population is limited to adults (18 years and older) with primary tinnitus that is persistent and bothersome. Tinnitus is often a bothersome, potentially significant complaint of patients with identified causes of hearing loss such as Meniere’s disease, sudden SNHL, otosclerosis, and VS. Patients with these identifiable and other causative diagnoses of secondary tinnitus are excluded from this guideline, as they are often excluded from nearly all randomized controlled trials (RCTs) of tinnitus management, making it impossible to generalize trial results. However, the GDG placed emphasis on the need for thorough clinical evaluation to identify these potentially treatable and sometimes serious disorders. Clinicians should decide whether to apply these recommendations to patients with these conditions on an individualized basis. The guideline also excludes patients with pulsatile tinnitus, or tinnitus related to complex auditory hallucinations or hallucinations related to psychosis or epilepsy. This is the first evidence-based clinical guideline developed for the evaluation and treatment of chronic tinnitus. This guideline provides clinicians with a logical framework to improve patient care and mitigate the personal and social impact of persistent, bothersome tinnitus. It will discuss the evaluation of patients with tinnitus, including selection and timing of diagnostic testing and specialty referral to identify potential underlying treatable pathology. It will then focus on the evaluation and treatment of patients with persistent primary tinnitus, with recommendations to evaluate and measure its influence, as well as for determining the most appropriate interventions to improve symptoms and QOL for tinnitus sufferers. In formulating this guideline, a broad range of topics were identified as quality improvement (QI) opportunities by the GDG. These topics fall into the three broad domains of: assessment, intervention/management, and education. The group further prioritized these topics to determine the focus of the guideline. Key Action Statements STATEMENT 1. HISTORY AND PHYSICAL EXAM: Clinicians should perform a targeted history and physical examination at the initial evaluation of a patient with presumed primary tinnitus to identify conditions that if promptly identified and managed may relieve tinnitus. Recommendation based on observational studies, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To promote a consistent and systematic approach to the initial evaluation of the patient with tinnitus Aggregate evidence quality: Grade C, based on observational studies Level of confidence in evidence: Moderate, as few if any studies specifically investigate the diagnostic yield or impact of history and examination on tinnitus patients Benefits: Identify organic, and potentially treatable, underlying causes (e.g., secondary tinnitus); minimize cost and administrative burden through a targeted approach to history and physical examination; streamline care/increase efficiency; improve patient satisfaction; identify patients with primary tinnitus who may benefit from further management (as outlined in this guideline) Risks, harms, costs: None Benefit-harm assessment: Preponderance of benefit Value judgments: Perception by the GDG that tinnitus sufferers may not receive thorough evaluations from clinicians; further perception that many clinicians are unaware of the optimal targeted history and physical examination to evaluate a patient with tinnitus Intentional vagueness: The definition of a “targeted”history and physical examination is elaborated upon in the supporting text Role of Patient Preferences: None Exclusions: None Policy level: Recommendation Differences of opinion: None. STATEMENT 2a. PROMPT AUDIOLOGIC EXAMINATION: Clinicians should obtain a comprehensive audiologic examination in patients with tinnitus that is unilateral, associated with hearing difficulties, or persistent (≥6months). Recommendation based on observational studies, with a preponderance of benefit over risk. Action Statement Profile Quality improvement opportunity: To address potential underutilization of audiologic testing in patients with tinnitus who are likely to have underlying hearing loss and to avoid delay in such diagnosis Aggregate evidence quality:Grade C, based on observational studies Level of confidence in the evidence: Moderate, as literature about the impact of prompt audiologic assessment on tinnitus management is scant Benefits: Prioritize the need for otolaryngologic evaluation (if not already completed) using audiologic criteria; identify hearing loss, which is frequently associated with tinnitus; characterize the nature of hearing loss (conductive, sensorineural, or mixed; unilateral or bilateral); detect hearing loss that may be unsuspected; initiate workup for serious disease that causes unilateral tinnitus and hearing loss (i.e., VS) Risks, harms, costs: Direct cost of examination; access to testing; time Benefit-harm assessment: Preponderance of benefit Value judgments: None Intentional vagueness: The term “prompt”is used to emphasize the importance of ordering a timely test and ensuring it is done, preferably within four weeks of assessment Role of Patient Preferences: Small; patients may participate in decisions regarding timing of audiogram Exclusions: None Policy level: Recommendation Differences of opinion: None. STATEMENT 2b. ROUTINE AUDIOLOGIC EXAMINATION: Clinicians may obtain an initial comprehensive audiologic examination in patients who present with tinnitus (regardless of laterality, duration, or perceived hearing status). Option based on observational studies, with a balance of benefit and harm. Action Statement Profile Quality improvement opportunities: To promote awareness of hearing loss associated with tinnitus, even in patients who do not have unilateral tinnitus or hearing difficulties, and to emphasize that clinicians do not have to wait six months before obtaining an audiogram if deemed appropriate Aggregate evidence quality: Grade C, based on observational studies and prevalence of HL in RCTs of tinnitus therapy Level of confidence in the evidence: High Benefits:Detect a hearing loss not perceived by the patient; SNHL, which is a treatable condition commonly associated with tinnitus; identify patients who may be candidates for sound therapy; identify opportunities for patient counseling/education Risks, harms, costs: Direct costs of audiologic testing; detection of minor audiologic abnormalities leading to potentially unnecessary further testing or referral; inconsistent access to testing Benefit-harm assessment:Equilibrium Value judgments:None Intentional vagueness: None Role of patient preferences: Large role for shared-decision making to proceed with audiologic examination Exclusions: None Policy level: Option Differences of opinion: None. STATEMENT 3. IMAGING STUDIES:Clinicians should not obtain imaging studies of the head and neck in patients with tinnitus, specifically to evaluate the tinnitus, unless they have one or more of the following: tinnitus that localizes to one ear, pulsatile tinnitus, focal neurological abnormalities, or asymmetric hearing loss. Strong recommendation against based on observational studies, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: Avoid overuse of imaging in patients with a low likelihood of any significant benefit from the imaging Aggregate evidence quality: Grade C, based on observational studies Level of confidence in the evidence: High Benefits: Avoid testing with low yield; avoid harms of unnecessary tests (radiation, contrast, cost); avoid test anxiety; avoid detecting subclinical, incidental findings Risks, harms, costs: Slight chance of missed diagnosis; relatively high costs and limited access to certain types of imaging studies Benefit-harm assessment: Preponderance of benefit Value judgments: GDG made this a strong recommendation against, instead of a recommendation against, based on consensus regarding the importance of avoiding low-yield, expensive tests with potential adverse events in patients with tinnitus Intentional vagueness: Specific imaging studies are specified in the supporting text including: CT, CTA, MRI, MRA Role of patient preferences: None Exclusions: None Policy level: Strong recommendation against Differences of opinion: None. STATEMENT 4. BOTHERSOME TINNITUS: Clinicians must distinguish patients with bothersome tinnitus from patients with non-bothersome tinnitus. Strong recommendation based on inclusion criteria for RCTs on tinnitus treatment, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To identify those patients in need of clinical management, and limit unnecessary testing and treatment for others Aggregate evidence quality: Grade B, based on inclusion criteria for RCTs on tinnitus treatment Level of confidence in evidence: High Benefits: Identify patients for further counseling and/or intervention/management; determine impact of tinnitus on health-related QOL; identify patients with bothersome tinnitus who may benefit from additional assessment for anxiety and depression; encourage an explicit and systematic assessment of patients to avoid underestimating or trivializing the impact of tinnitus; avoid unnecessary interventions/management of patients with non-bothersome tinnitus Risks, Harms, Costs: Time involved in assessment Benefit-Harm Assessment: Preponderance of benefit Value Judgments: None Intentional Vagueness: Method of distinguishing bothersome vs. non-bothersome is not specifically stated. One or more of the validated questionnaires described in the supporting text may be helpful Role of Patient Preferences: None Exclusions: None Policy Level: Strong recommendation Differences of opinion: None. STATEMENT 5. PERSISTENT TINNITUS: Clinicians should distinguish patients with bothersome tinnitus of recent onset from those with persistent symptoms (≥6months) to prioritize intervention and facilitate discussions about natural history and follow-up care. Recommendation based on inclusion criteria in RCTs, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To identify patients with a duration of tinnitus similar to that studied in RCTs of tinnitus treatment; to identify those who may need and benefit from intervention; and to avoid inappropriate interventions for patients with shorter duration tinnitus Aggregate evidence quality: Grade B, based on inclusion criteria in RCTs Level of confidence in the evidence: Moderate, based on varying tinnitus duration in RCTs, with some including patients with tinnitus of less than three months’duration Benefits: Identify patients who have duration of tinnitus similar to the patients included in RCTs, and identify those patients who are most likely to benefit from intervention Risks, Harms, Costs: Defer treatment that may benefit some tinnitus patients who do not have persistent symptoms Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Despite some variation in inclusion criteria for duration of tinnitus used in clinical trials, the GDG felt that six months was a reasonable time to conclude that the tinnitus would likely persist Intentional Vagueness: None Role of Patient Preferences: None Exclusions: None Policy Level: Recommendation Differences of opinion: None. STATEMENT 6. EDUCATION AND COUNSELING: Clinicians should educate patients with persistent, bothersome tinnitus about management strategies.Recommendation based on studies of the value of education and counseling, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To address potential underutilization of education and counseling by clinicians who manage patients with persistent, bothersome tinnitus. To bring awareness of available management strategies to the patient Aggregate evidence quality: Grade B, based on studies of the value of education and counseling in general, and Grade C based on such studies in tinnitus in particular Level of confidence in the evidence: High Benefits: Improved QOL; increased ability to cope with tinnitus; improved outcomes and patient satisfaction; less healthcare utilization Risks, harms, costs: Direct cost and time Benefit-harm assessment: Preponderance of benefit Value judgments: None Intentional vagueness: None Role of patient preferences: None Exclusions: None Policy level: Recommendation Differences of opinion: None. STATEMENT 7. HEARING AID EVALUATION: Clinicians should recommend a hearing aid evaluation for patients with hearing loss and persistent, bothersome tinnitus.Recommendation based on observational studies with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunities: To promote awareness of the beneficial effect of hearing aids on tinnitus and encourage utilization of this first-line audiologic intervention for patients with tinnitus, even those who might otherwise be marginal hearing aid candidates Aggregate evidence quality: Grade C, based on observational studies Level of confidence in the evidence: High Benefits: Raise awareness of potential beneficial effects of hearing aids on tinnitus; ensure that patient receives proper guidance regarding benefits and costs of hearing aids; provide patients who have hearing loss with access to information and interventions that may alleviate hearing loss and improve function/QOL Risks, harms, costs: direct cost related to dispensing of a hearing aid Benefit-harm assessment: Preponderance of benefit Value judgments: Perceived lack of awareness regarding the ability of hearing aids to improve QOL for patients with tinnitus Intentional vagueness: The level of hearing loss is not specified because hearing loss-associated tinnitus may benefit from hearing aids even if the hearing loss is only of a mild degree, or even if there is a more severe unilateral SNHL associated with the tinnitus Role of patient preferences: Patient may accept or decline the recommendation to pursue a hearing aid evaluation Exclusions: None Policy level: Recommendation Differences of opinion: None. STATEMENT 8. SOUND THERAPY: Clinicians may recommend sound therapy to patients with persistent, bothersome tinnitus. Option based on RCTs with methodological concerns, with a balance between benefit and harm. Action Statement Profile Quality improvement opportunity: To promote awareness and utilization of sound therapy as a reasonable management option in patients with persistent, bothersome tinnitus Aggregate evidence quality: Grade B, based on RCTs with methodological concerns Level of confidence in the evidence: Medium, as strength of evidence is low. Benefits: Access to technology/devices that may relieve tinnitus; improve QOL, sleep, and concentration Risks, harms, costs: Consequences of recommending an intervention of uncertain efficacy; promoting false hope; costs associated with sound therapy Benefit-harm assessment: Equilibrium Value judgments: None Intentional vagueness: None Role of patient preferences: Significant role in deciding whether to pursue sound therapy and to choose among the available options Exclusions: None Policy level: Option Difference of opinion: One GDG member expressed a difference of opinion about mechanisms of sound therapy, in particular with the concepts of partial and total masking. STATEMENT 9. COGNITIVE BEHAVIOR THERAPY (CBT): Clinicians should recommend CBT to patients with persistent, bothersome tinnitus. Recommendation based on RCTs, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To promote awareness and utilization of CBT as an effective management option in patients with persistent, bothersome tinnitus Aggregate evidence quality: Grade A, based on multiple systematic reviews of RCTs Level of confidence in the evidence: Moderate, based on concerns about methodology and sample size of trials Benefits: Treatment of depression and anxiety; improved QOL, tinnitus coping skills, and adherence to other tinnitus treatments Risks, harms, costs: Direct cost; time involved (multiple sessions, 1-2 hrs. each); availability to services may be limited Benefit-harm assessment: Preponderance of benefit Value judgments: None Intentional vagueness: None Role of patient preferences: None Exclusions: None Policy level: Recommendation Differences in opinion: None. STATEMENT 10. MEDICAL THERAPY: Clinicians should not routinely recommend antidepressants, anticonvulsants, anxiolytics, or intratympanic medications for a primary indication of treating persistent, bothersome tinnitus.Recommendation against based on systematic reviews and RCTs with methodological concerns, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To decrease the use of medications that may have no benefit and have significant potential side effects, in the management of patients with tinnitus Aggregate evidence quality: Grade B, based on RCTs with methodological concerns and systematic reviews demonstrating a low strength of evidence Level of confidence in the evidence: Medium regarding the lack of efficacy of medical therapy as a primary treatment for persistent bothersome tinnitus, as several studies with methodological flaws, bias, and lack of power did show some benefit in certain tinnitus outcome measures Benefits: Avoid unproven therapy, side effects/adverse events (including tinnitus), and false hope; reduce expense. Avoid use of medications that are not approved for use in geriatric population Risks, harms, costs: Denying some patients benefit Benefit-harm assessment: Preponderance of benefit Value judgments: Although these therapies appear to be beneficial in some studies, the evidence from systematic reviews and RCTs is insufficient to justify routine use in managing tinnitus patients, especially given the known harms, cost of therapy, and potential for some medications (e.g., antidepressants) to worsen tinnitus Intentional vagueness: The term “routine”is used to acknowledge there may be individual circumstances for which clinicians and patients may wish to pursue therapy Role of patient preferences: Limited; a trial of medication may be administered based on individual circumstances Exclusions: Patients with depression, anxiety, or seizure disorders that constitute an indication for pharmacologic therapy independent of tinnitus Policy level: Recommendation against Differences in opinion: None. STATEMENT 11. DIETARY SUPPLEMENTS: Clinicians should not recommend Ginkgo biloba, melatonin, zinc, or other dietary supplements for treating patients with persistent, bothersome tinnitus.Recommendation against based on RCTs and Systematic Reviews with methodological concerns, with a preponderance of benefit over harm. Action Statement Profile Quality improvement opportunity: To avoid use of commonly-available supplements that have no proven efficacy and pose potential harm, in the management of patients with tinnitus Aggregate evidence quality: Grade C, RCTs and systematic reviews with extreme heterogeneity; most of the RCTs raise significant concerns regarding methodology and subject selection Level of confidence in the evidence: High confidence regarding potential harm and adverse effects related to these agents, particularly in the elderly population; low confidence in benefits due to methodological concerns and study quality and ability to generalize results to patients with persistent, primary tinnitus Benefits: Avoid unproven therapy, side effects/adverse events (including tinnitus), and false hope; reduce expense Risks, harms, costs: None Benefit-harm assessment: Preponderance of benefit Value judgments: Concern regarding the actual content and dosage of proposed active agents in these preparations, as they are currently packaged OTC. Many of these supplements, not under the regulations of the USFDA, have varying amounts of the “active”agent. The GDG was concerned over the widespread availability for easy purchase of these agents without considering potential drug interactions and adverse events Intentional vagueness: The term “dietary supplements”is used to generalize nutritional and herbal supplements promoted as remedies for tinnitus Role of patient preferences: Limited role Exclusions: None Policy level: Recommendation against Differences in opinion: The majority of the GDG felt there was a clear predominance of harm over benefit; a minority felt there was an equilibrium. None of the group perceived a preponderance of benefit over harm. STATEMENT 12. ACUPUNCTURE: No recommendation can be made regarding the effect of acupuncture in patients with persistent bothersome tinnitus. No recommendation based on poor quality trials, no benefit, and minimal harm. Action Statement Profile Quality improvement opportunity: Limited, to educate patients and providers about the controversies regarding the use of acupuncture for tinnitus Aggregate evidence quality: Grade C, based on inconclusive RCTs and the presence of costs and potential harm with no established benefit with the use of acupuncture for tinnitus Level of confidence in the evidence: Low regarding benefit because of heterogeneity and methodological flaws in the RCTs; high regarding harm or cost, with the understanding that serious harm from acupuncture is rare Benefits: No direct benefits of no recommendation Risks, harms, costs: Cost of acupuncture therapy, time required for therapy, and potential delay in instituting sound therapy or hearing aids Benefit-harm assessment: unknown Value judgments: The poor quality of the data, the limited potential for harm from acupuncture kept the GDG from making a recommendation about acupuncture Intentional vagueness: None Role of patient preferences: Significant role for shared decision making; patients may wish to try acupuncture based on circumstances Exclusions: None Policy level: No recommendation Differences in opinion: Minor: The GDG was divided between making no recommendation and making a recommendation against the use of acupuncture. STATEMENT 13. TRANSCRANIAL MAGNETIC STIMULATION (TMS): Clinicians should not recommend TMS for the treatment of patients with persistent, bothersome tinnitus. Recommendation against based on inconclusive RCTs. Action Statement Profile Quality improvement opportunity: To avoid use of a therapy that has inconclusive efficacy and poses potential financial and physical harm, in the management of patients with tinnitus Aggregate evidence quality: Grade B, based on inconclusive RCTs and systematic reviews that show low strength of evidence Level of confidence in the evidence: High regarding the absence of a long-term (>6 months) benefit of TMS; moderate regarding the absence of a short-term benefit, since a minority of trials demonstrated transient beneficial outcomes, and strength of this evidence is low Benefits: Avoid unproven therapy, side effects/adverse events, and false hope; reduce expense Risks, harms, costs: Denying some patients benefit Benefit-harm assessment: Preponderance of benefit Value judgments: None Intentional vagueness: None Role of patient preferences: Limited Exclusions: Patients with depression or other neurological conditions for which TMS is indicated Policy level: Recommendation against Differences in opinion: None. Disclaimer The clinical practice guideline is provided for information and educational purposes only. It is not intended as a sole source of guidance in managing patients with tinnitus. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to diagnosing and managing this program of care. As medical knowledge expands and technology advances, clinical indicators and guidelines are promoted as conditional and provisional proposals of what is recommended under specific conditions but are not absolute. Guidelines are not mandates; these do not and should not purport to be a legal standard of care. The responsible physician, in light of all circumstances presented by the individual patient, must determine the appropriate treatment. Adherence to these guidelines will not ensure successful patient outcomes in every situation. The AAO-HNSF emphasizes that these clinical guidelines should not be deemed to include all proper treatment decisions or methods of care, or to exclude other treatment decisions or methods of care reasonably directed to obtaining the same results. References Rosenfeld RM, Shiffman RN. Clinical Practice Guideline Development Manual: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. 2009; 140(Suppl1). SI-43. Hoffman HJ, Reed GW. Epidemiology of tinnitus. In: Snow JB. Ed. Tinnitus: Theory and Management. Lewiston, NY: BC Decker; 2004:16-41. Henry JA, Zaugg TL, Myers PJ, Schechter MA. The role of audiologic evaluation in progressive audiologic tinnitus management. Trends Amplif. 2008;12(3):170-187. Vital and Health Statistics: Current Estimates from the National Health Interview Survey, 1994. Series 10: Data from the National Health Survey No. 193; US Department of Health and Human Services Public Health Service, CDC, National Center for Health Statistics, DHHS Publication No. (PHS) 96-1521. Nondahl DM, Cruickshanks KJ, Huang GH, et al. Tinnitus and its risk factors in the Beaver Dam Offspring Study. Int J Audiol. 2011; 50(5):313-320. US Department of Veterans Affairs. Annual Benefits Report: Fiscal Year 2012. In: Affairs DoV, ed. Washington, DC. 2013. Lewis JE, Stephens SDG, McKenna L. Tinnitus and suicide. Clin Otolaryngol Allied Sci. 1994;19(1):50-54.
Happy-Members
Membership in the Academy Is a Great Investment
At more than 118 years old, the American Academy of Otolaryngology—Head and Neck Surgery is proud to be the world’s largest professional organization serving otolaryngologists. We have Members across the U.S. and around the globe. Our nearly 12,000 Members are representative of almost all segments of the profession. From physician assistants and nurse practitioners, to residents and fellows-in-training, to those who have proudly served the profession for their entire career, the AAO-HNS is your partner from residency to retirement. You practice in unparalleled times and your job is to be efficient, passionate, and effective in the care you offer the patients you serve. Our mission as your professional home is to help you to achieve excellence and provide the best ear, nose, and throat care through professional and public education, research, and health policy advocacy. We do this through all of the services that we provide to you, our Members, to keep you up-to-date in this fast-changing healthcare environment. Your return on your investment in AAO-HNS, or any professional association, is a personal matter. How much or little you choose to take advantage of what the Academy has to offer is up to you. Engagement in activities may be as simple as keeping up-to-date by accessing the multitude of information that comes your way, becoming a journal reviewer, completing an RUC survey, or simply connecting via our online community. Or, you may choose to serve on a committee or represent the profession in other ways through the AAO-HNS. Some may view membership value from the perspective of where they are in their careers, while others may see the value in a particular practice setting. Your level of engagement and value gained is up to you. More than 262,000 CME credits were awarded by the Academy last year! We typically hear that members join and remain members of the AAO-HNS because they value the information we provide, the networking opportunities with like-minded individuals, the education, and access to our clinical practice guidelines. Information is provided through our highly rated Bulletin member magazine and the scientific journal, Otolaryngology–Head and Neck Surgery. Our journal leads the specialty’s journals in articles relative to evidence-based medicine. Additionally, there are numerous other publications geared toward select demographics and issues that provide great information for you. And, networking is one of the key benefits of belonging to a professional association, whether accomplished by attending a meeting or communicating via our member portal, ENTConnect. We provide countless opportunities for professional development and to earn your continuing medical education (CME) through our Foundation’s education activities. Our Annual Meeting & OTO EXPOSM is second to none and attracts thousands from around the world. AcademyU® offers education opportunities online, in face-to-face settings, and other venues to meet your needs. And, many of these opportunities are included with your membership, or substantially discounted. “Attending annual meetings has helped me form relationships and friendships, and it has facilitated discussions and learning that could never have happened in any other venue.”—Larry M. Simon, MD. We strive to meet your needs at every stage of your career. Our Section for Residents and Fellows-in-Training gives this group of members a voice in determining the course of their profession while still in training. There are opportunities to get involved in leadership of this section and to propose resolutions to vote and act on. Grants are available for those desiring to take on leadership roles and expand their understanding of the profession. The Women in Otolaryngology (WIO) Section is committed to the advancement and empowerment of women at all career levels of otolaryngology. By offering mentoring, partnerships, networking, and educational programming, WIO cultivates our members’personal and professional growth. The section provides leadership opportunities and ways to address needs and cultivate women as leaders in the specialty. We also recognize generational diversity. As such, we have recently established our Young Physicians Section. Similar to our other sections, this important section provides the resources, leadership opportunities, and mentorship for our members who have recently completed their residency and fellowship programs and are beginning the next phase of their professional lives. We accepted more than 340 applications for 240 committee positions. These new committee members will serve two-year terms beginning this month. This is an excellent and effective means of providing direct input into developing policies that influence the profession, or charting the course of the AAO-HNS. Each year as committee members’terms come to an end, we reach out to encourage other members to apply to be appointed in their place. Other members have opted to get involved by representing their state or local society through our Board of Governors. This is the grassroots member network, which provides direct feedback to the AAO-HNS governing bodies from the local level. The Board of Governors plays a vital role in the Academy and in the specialty to identify and respond to issues that confront otolaryngologists and their patients. These issues include legislative and regulatory proposals at the local, state, and federal levels as well as socioeconomic and public relations matters. Additionally, our research and quality staff develop clinical practice guidelines, which allow clinicians to optimize patient care by making decisions based on best evidence. Patients also benefit through the promotion of better outcomes, greater consistency of care, and fewer unnecessary or ineffective interventions. We have an ongoing relationship with more than 50 International Corresponding Societies, where we share information and create long-lasting relationships. These societies represent more than 700 of our members, and thousands more in various capacities and career settings in the profession. If you want to give back to the profession in other ways, join our members who commit countless hours of their personal time to humanitarian missions to support those less fortunate. The Academy has resources available to assist in those trips, including opportunities to apply for grants to subsidize these important missions. You don’t need to leave home to take advantage of all we have to offer. This past year, we redesigned our website, www.entnet.org, based on your needs. The new website is user-friendly, built on adaptive technology, and is available via desktop, laptop, tablet, or smartphone. The “Find an ENT”option is available to the public. This feature is accessed by hundreds of thousands of individuals annually when searching for an ENT/otolaryngologist. Through our website, you can access a multitude of resources and tools, including the PQRSWizard, Patient Safety Portal, and our digital library and educational programs. Our new member engagement portal, ENTConnect, provides a social media-like setting that is private, for members only, and allows you to have conversations with your colleagues and share documents. You can also personalize your profile to allow optimal networking with colleagues. When you invest in your professional associations for the coming year, take a look at everything your Academy has to offer. With networking and education opportunities, resources to improve your practice, evidence-based guidelines, advocacy initiatives, and more, it’s an investment you can’t afford to not make. Think of the AAO-HNS as your personal association that has the resources you need!
Charles W. Vaughan, MD
Charles W. Vaughan, MD—a Pioneer in Otolaryngology – ONLINE EXCLUSIVE
Louis Insalaco, MD Charles Williams Vaughan, MD, of Boston, who died in May, was a pioneer in otolaryngology. He was a clever innovator, a highly effective educator, and a superb mentor. A review of the contributions made by Dr. Vaughan parallels milestones in the development of modern otolaryngology. Dr. Vaughan worked with M. Stuart Strong, MD, physicists, and other clinicians to harness the carbon dioxide laser for use in otolaryngic surgery. Together they developed laryngoscopes and instruments to be used in microlaryngeal surgery. In a nearly uncanny kind of symmetry, Dr. Vaughan developed a tonsil malignancy late in his life that ordinarily would be treated with local surgical excision possibly combined with neck dissection and radiation therapy. However, always the innovator and unconventional thinker, Dr. Vaughan convinced his otolaryngologist, one of his former residents, to excise the tonsil cancer using a laser. Despite unconventional treatment, Dr. Vaughan remained free of tonsil cancer for the rest of his life. Around age 70, Dr. Vaughan became an amateur videographer and he captured for posterity chats with many of the foremost otolaryngologists of the modern era. When he was operating on a patient, Dr. Vaughan was performing several concurrent tasks; with his hands, he was completing the appropriate surgical procedure as he was demonstrating to those around him the meticulous technique required to achieve excellent results; simultaneously, he was considering ways to improve the procedure, and in his conversational patter he was prompting all around him to create innovations that could potentially benefit patients. There is much to be learned from the life and accomplishments of Dr. Vaughan.
Wendy B. Stern, MD, Chair, BOG
Everything’s in Place for Action
As I sit here writing this article in early August, my mind focuses on the likely state of affairs in the house of medicine, our Academy, and the Board of Governors (BOG) in October. A lot will have transpired by then. The original target date for ICD-10 will have passed. Hopefully, derailed talks regarding the repeal of the SGR will have resumed, the Independent Payment Advisory Board will still be on hold, and among the many fights and crusades of our Academy the fights for the physician-led health team, transparency in advertising, access to high quality healthcare and services such as implantable hearing aids will prevail. The Academy election results will be known and we will have new leaders. The Annual Meeting will have passed and many of our members will have benefited from the opportunity to network, learn, and become engaged. Those newly appointed to Academy committees will begin to serve. The Board of Governors will have conducted its committee meetings, General Assembly, and elections. This fall will be busy. The BOG stands ready to serve as the conduit between what is happening in all of our backyards and the Academy. To that end we will be working to better engage all eligible societies. The BOG Rules and Regulations Committee is charged with helping societies establish a formal relationship with the BOG and accessing information that will enable a stronger local or specialty society. We have set up a regionalization plan including regional representatives to member societies and a representative to specialty societies to facilitate the flow of information. We have made a formal relationship with the Physician Payment Policy (3P) workgroup. The BOG Socioeconomic and Grassroots (SEGR) Committee has been developing polls on hot topics to understand the opinions of our membership. The BOG Legislative Affairs Committee is continually monitoring state and federal legislative representatives and has been conducting briefing conference calls open to the legislative reps from member societies and promoting the I-Go Program. We have formal representation on the Guidelines Task Force, the Specialty Society Advisory Council (SSAC), and the Nominating Committee. As the new chair of the BOG, I am committed to seeing these activities flourish. ENTConnect will allow better communication among all members of the Open Forum and BOG committee members on our community site. The revamped website allows interested societies and members to access BOG programs and resources. During the next few months we will be working on the March 2015 AAO-HNS/F Leadership Forum. This is an opportunity to meet in person, sit in on our committee meetings, and represent your societies and your needs. We need activism now more than ever. The challenges are known and the BOG structure is specifically designed to get the job done. I believe this year our committees and committee members are ready to work hard. We will develop task forces to serve your needs. We need you and your societies to make this effort successful! Stay alert and connect: bog@entnet.org
David R. Nielsen, MD AAO-HNS/F EVP/CEO
Leadership and Transition
The theme of the Opening Ceremony for our recently completed and successful Annual Meeting & OTO EXPOSM was “Transforming, Thriving, Together.”I want to emphasize the importance of this theme, as it is not just alliterative platitude, but an accurate description of our transition during this time of uncertainty related to healthcare reform. While admittedly this is partly aspirational, as a specialty we have achieved admirable success in rapidly developing a strong focus on new quality and knowledge products, health services and patient safety research, and successful advocacy for the specialty. Leadership is required at every level, from every member, and from each element of our governance and structure in order for our specialty to thrive as we transition to the change around us. As businessman, writer, and founder of The Center for Leadership, Max Depree stated in his book Leadership is an Art: “In the end, it is important to remember that we cannot become what we need to be by remaining what we are.” As hard as it feels to manage the transitions and transformations that are being asked of physicians, we can take heart in knowing that as physicians we are trained and expert in being flexible. Every patient is different, every clinical challenge is nuanced. It is in our nature to strive, to search, to learn, and to improve. In other words, to thrive while we transform to a better version of ourselves. Another of the most storied contemporary leadership experts, Peter Drucker has written, “Leadership is not magnetic personality—that can just as well be a glib tongue. It is not making friends and influencing people—that is flattery. Leadership is lifting a person’s vision to higher sights, the raising of a person’s performance to a higher standard, the building of a personality beyond its normal limitations.”As we advocate for what should not change—excellence in healthcare; a focus on our patients and their needs; our integrity; our dedication—we must be both leaders and followers devoted to the principles of that higher standard and lifting our vision to higher sights. We have been richly blessed with exceptional leaders at all levels in the Academy boards, committees, work groups, and task forces. We must be wise enough to choose the best leaders who inspire us to follow their collective plan for improving our care of and defending our commitment to our patients and their health. This requires integrity. As Dwight Eisenhower stated, “In order to be a leader a [person] must have followers. And to have followers, a [person] must have their confidence. Hence, the supreme quality for a leader is unquestionably integrity. Without it, no real success is possible, no matter whether it is on a section gang, a football field, in an army, or in an office. If a [person’s] associates find him [her] guilty of being phony, if they find that he [she] lacks forthright integrity, he [she] will fail.” No matter what else we do, we must continue to develop and be effective leaders. As we continue to transform and thrive together, let’s not forget that.
Gayle E. Woodson, MD, AAO-HNS/F President
The Sky Is Falling—Again—and We Will Survive
I am honored to serve as your president this year, as we continue to deal with significant challenges to our profession and our specialty. It has been said that change is the only constant thing in life. This is not entirely so. There are other constants, among them: death, taxes, conflicts… When I was 10 years old, John F. Kennedy was campaigning for president with a plan to initiate Medicare. Among physicians, there was widespread fear and panic over the specter of socialized medicine that would inevitably result. Medicare was initiated. Nevertheless, the healthcare system adapted and thrived. A 1973 Newsweek article reported a great push to expand medical school enrollment—it was inevitable that healthcare would be nationalized within a short time and we would not have enough physicians. The article also bemoaned the decreasing number of applications for medical school. There would not be enough qualified applicants for schools to fill the increased capacity…unless they began to admit more blacks and women! The crisis passed, and I was able to get into medical school in 1972, in the wave of women entering the profession. My father retired from practice in 1990. His book, A Golden Window in Time, extols the period in which he had been privileged to practice medicine. There were so many advances: penicillin, polio vaccine, and electrocardiography. Yet, he lamented the changes in healthcare reimbursement that made it so much more difficult to practice. In the ’90s, I remember feeling fear that our whole healthcare system, and particularly academic medical centers, would implode. Despite the strains, we are still here, but facing even greater hurdles and the threat of fragmentation within our specialty. Fortunately, resilience is another constant in life. We persevere and adapt as we continue to provide excellent care to our patients and train new physicians for the future. The American Academy of Otolaryngology—Head and Neck Surgery supports us in our efforts, but is only as good as the combined efforts and collective wisdom of its membership. So attend the meetings, work on committees, and make your voices heard.