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PIHL Research Guidance Documents

The Pharmaceutical Interventions for Hearing Loss (PIHL) working group was chartered in 2012 for the purpose of reviewing and maintaining state-of-the-science knowledge that supports translational therapies for the prevention and rescue of noise-induced hearing loss. Foundational knowledge can be used to spotlight minimal functional performance requirements of potential agents and, importantly, to identify the evidence-based laboratory, animal, exposure, and clinical assessment methodologies that represent best practices. It can also be used to promote comparability across trials investigating new drug development.

The guidance offered below is the culmination of two years of working group discussion, literature review, and open dialogue during two state–of-the-science symposia involving expert investigators. Discussions focused on analyzing issues most relevant to participation in investigational new drug (IND) development and translation of science for the prevention and/or rescue of hearing loss. It represents the outcome of subject matter review, debate, and advisory consensus to bridge literature gaps and recommend appropriate standards and technologies for future PIHL studies.

Hearing injuries due to noise have claimed, and continue to claim many thousands of military and civilian casualties. Noise-induced hearing loss limits communication, opportunity, and overall quality of life. Advances in the development of pharmaceutical intervention can play a critical role in preventing noise-induced hearing loss. Through PIHL, the HCE works to guide and facilitate research and its translation to benefit military members.

It has been my privilege to work with the PIHL working group to develop the guidelines presented here, and I am honored to endorse their proposed recommendations. These represent collegial and collaborative rules of engagement as defined by a naturally competitive field of experts who share HCE’s commitment to protect the health and safety of Service members.

Col Mark Packer, USAF, MC, FS

Executive Director, DoD Hearing Center of Excellence

Downloadable PDF links:

  1. Biomarkers of Oxidative Damage and Inflammation
  2. Guidelines for Adult Auditory Threshold Measurement for Significant Noise Induced Threshold Shift
  3. Measurement of Tinnitus
  4. Non-Cochlear Effects of Noise
  5. Statistical Considerations
  6. Supra-Threshold Testing Using Speech-in-Noise and Auditory Evoked Potentials
  7. Temporary and Permanent Noise-Induced Threshold Shifts
  8. The Genetic and Epigenetic Basis of Noise
  9. Use of Otoacoustic Emissions to Assess the Efficacy of a Pharmaceutical Otoprotective Agent

PIHL Author Biographies

  • Douglas S. Brungart, PhD

    Douglas S. Brungart, PhD, is currently the Chief Scientist at the Audiology and Speech Center at Walter Reed National Military Medical Center, which serves as the flagship entity for clinical care in audiology and speech pathology within the DOD medical system and has a long-standing history of conducting world-class clinical and applied research in speech and audiology with direct relevance to military medicine. The Center is currently working with the U.S. Army Public Health Command in a major effort to conduct clinical and field studies to support the objectives of the U.S. Army Hearing Program, including an initiative to develop new “Auditory Fitness for Duty” standards for military personnel. Dr. Brungart obtained his doctorate in Computer Science and Electrical Engineering from the Massachusetts Institute of Technology in 1998. From 1993 to 2009, he worked at the Battlespace Acoustics Branch at the Air Force Research Laboratory at Wright-Patterson AFB, OH. Since 2009, he has been the Chief Scientist at the Audiology and Speech Center at Walter Reed National Military Medical Center in Bethesda, MD. Dr. Brungart has published many peer-reviewed journal articles on auditory perception, and holds more than 10 U.S. patents related to auditory perception and speech communication. In 2009, he was designated as a “Fellow” by the Acoustical Society of America. Since 2011, Dr. Brungart has served as the Interim Director of Research for the HCE, where his scientific research and subject matter expertise is being utilized to support the HCE mission.

  • Kathleen Campbell, PhD

    Kathleen Campbell, PhD, distinguished Scholar and Professor at Southern Illinois University (SIU) School of Medicine, ran audiology clinics in the US and Canada for over 25 years and audiology research for over 30 years. She served on the American Academy of Audiology (AAA) Board of Directors, received an AAA Presidential Citation, 2 Medical Innovators Award and was made a Fellow by the American Speech Language Hearing Association. She received the Mensa Copper Black Award for her patents, and the Board of Trustees Award for her contributions in chairing the Mensa national research awards committee. She was the 2012 Inventor of the Year for the Southern Illinois University System, and was the 2014 SIU Scholar of Excellence, SIUs highest distinction. She authored Essential Audiology for Physicians and edited/authored Pharmacology and Ototoxicity for Audiologists. She has received a number of grants from NIH and other agencies for her research in otoprotective agents and is the inventor of the protective agent D-methionine patents. Her grants and patent income to SIU exceeds 8.2 million dollars. Her patents are owned by her employer, SIU School of Medicine. She is currently running FDA approved, and DOD funded Phase 3 clinical trials of D-methionine prevention and treatment of noise induced hearing loss and tinnitus, in US Army troops.

  • Royce Ellen Clifford, MD

    Royce Ellen Clifford, MD, received a MPH degree at Harvard in 2006, followed by the Harvard Public Health Innovator Award in 2013 for continuing publications in the fields of acoustic trauma and hearing loss. As a board-certified Ear, Nose, and Throat Surgeon and Aerospace/Preventive Medicine Physician, she has spent the last decade in basic science and operational research focusing on noise and resultant hearing loss in the military. While on deployment in the Middle East, including Iraq, she obtained first-hand knowledge of the operational effects of explosive devices on military personnel. During her tenure as Officer-In-Charge of the Aviation Clinic at Marine Corps Air Base Camp Pendleton, she has worked with Naval Medical Center San Diego and Harvard towards the goal of finding effective modes of intervention for the treatment and prevention of noise-induced hearing loss. She flew 2 years with a San Diego-based F/A-18 squadron and has served in the aviation community for 14 years, including two years as Senior Medical Officer on the aircraft carrier USS GEORGE WASHINGTON (CVN-73). She is currently a Visiting Scientist at Harvard School of Public Health and operational advisor to Code 42 at Office of Naval Research on projects involving noise-induced hearing loss.

  • Howard Greene, PhD, MS, MBA

    Howard Greene, PhD, MS, MBA, is a research epidemiologist with the Geneva Foundation and located supporting the DOD Hearing Center of Excellence onsite at the Navy Medical Center San Diego. Dr. Green’s current research interests include the effects of impulse noise on hearing. He received his PhD in Environmental Medicine/ Epidemiology and MS in Inhalation Toxicology from New York University, and his MBA from the University of Southern California. He has a broad background in occupational and environmental epidemiology, inhalation toxicology, risk assessment, exposure modeling, and statistics and is the co-author of a patent for the “Performance Assurance Computerized Test,” a test of fitness for duty.

  • Gerald M. Haase, MD

    Gerald M. Haase, MD, is Clinical Professor of Surgery, University of Colorado, School of Medicine and Children’s Hospital Colorado. He is also Chief Medical Officer of Premier Micronutrient Corporation and has conducted medical research and clinical trials for three decades including surgical innovations in oncology and development of novel strategies for antioxidant micronutrient therapy. He was educated at the Johns Hopkins University and Tufts University School of Medicine and received graduate honors in research. His postgraduate training was from the University of Colorado, Health Sciences Center, Children’s Hospital Medical Center, Boston, and Nationwide Children’s Hospital, Columbus, Ohio. He is licensed to practice in Colorado, Massachusetts and Ohio, and held certification from the American Board of Surgery in General Surgery, Pediatric Surgery and Critical Care. Dr. Haase was Chairman of the Department of Surgery, Children’s Hospital Colorado, a consultant surgeon, Department of the Army, Fitzsimmons Medical Center and a Director on the National Board of the American Cancer Society. He has published 180 scientific papers, holds eight U.S. patents for antioxidant micronutrient therapy and been the recipient of clinical research grants and contracts funded at a several million dollar cumulative level. He was an editorial reviewer for several medical journals and an editorial board member of The Annals of Surgical Oncology. He is a member of more than 25 professional societies including the American Association for Cancer Research, International College of Surgeons, New York Academy of Sciences and American College of Physician Executives.

  • Tanisha L. Hammill

    Tanisha L. Hammill holds Master's degrees in Ethics/Religious Studies and Public Health Administration. She has ten years of experience as an administrator for hearing programs in the US military. Her duties include reports and inputs to policy changes, regulatory planning and adherence, enterprise-wide research programmatic design, coordination and execution. She has specific program oversight responsibilities in Fitness for Duty and Return to Duty Standards, Pharmaceutical Interventions for Hearing Loss (PIHL), Allied NeuroSensory Warrior-Related Research (ANSW2R) and the Collaborative Auditory & Vestibular Research Network (CAVRN).

  • James A. Henry, PhD

    James A. Henry, PhD, is employed as a Research Career Scientist at the VA National Center for Rehabilitative Auditory Research located at the Portland, Oregon VA Medical Center. He is also Research Professor in the Dept. of Otolaryngology-Head & Neck Surgery at Oregon Health & Science University (OHSU) in Portland. He has conducted tinnitus clinical research since 1995. He recently served on the AAO-HNS committee that developed the clinical guidelines for tinnitus.

  • Michael Hoffer, MD, FACS

    Michael Hoffer, MD, FACS, is currently serving as a Professor of Otolaryngology at the University of Miami and Academic Liaison for the DoD Hearing Center of Excellence. Dr. Hoffer assumed these roles after an over twenty year military career. During his time in the military and at the University, Dr. Hoffer performs both basic and clinical research and serves as a practicing clinical neurotologist. Dr. Hoffer’s lab focuses on traumatic damage to the inner ear and brain. He has authored or co-authored over sixty papers and has a particular expertise in dizziness and balance disorders as well as neurosensory consequences after mild traumatic brain injury (mTBI) Dr. Hoffer and his collaborators have done pioneering work on pharmaceutical countermeasures for mTBI as well as optimized diagnosis and management of neurosensory disorders seen after mTBI.

  • Jonathan Kil, MD

    Jonathan Kil, MD, is the co-founder and Chief Medical Officer of Sound Pharmaceuticals, a private biotechnology company in Seattle that has developed three proprietary product pipelines aimed at improving and restoring auditory function in humans. Dr. Kil has expertise in basic, preclinical and clinical studies involving noise-induced and chemotherapy-induced hearing loss. He has been the principal investigator of several federal grants and R&D awards for his work in hearing research that has examined the mechanisms of inner ear hair cell loss, repair and protection, and supporting cell and hair cell regeneration via p27Kip1 inhibition totaling $5.8M. Dr. Kil has lead the FDA interactions on two INDs with the FDA and has now completed an interventional Ph-II clinical trial with SPI-1005 in NIHL. He is the inventor on several issued US patents and serves as a Board Trustee to the University of Washington's Harborview Medical Center and is Board President of the Academy for Precision Learning, an independent autism inclusion school in Seattle.

  • Dawn Konrad-Martin, PhD, CCC-A

    Dawn Konrad-Martin, PhD, CCC-A, is a Research Investigator at the VA RR&D Center of Excellence, the National Center for Rehabilitative Auditory Research (NCRAR) located in Portland, Oregon, and is Associate Professor in the Department of Otolaryngology at Oregon Health and Sciences University. Her research contributions include early efforts to examine distortion-product otoacoustic emission (DPOAE) source contributions, one of the first reports of stimulus-frequency otoacoustic emissions measured in impaired ears, and the use of clinical decision theory techniques to examine DPOAE test performance for identifying changes in hearing from ototoxic drugs. Her current research involves developing OAE-based techniques for ototoxicity monitoring, and determining the auditory system deficits responsible for impaired speech understanding among individuals who are older and/or have diabetes. Prior to joining the NCRAR, Dawn completed a PhD in Audiology at the University of Washington, a Post-Doctoral Fellowship at Boys Town National Research Hospital, and was an Assistant Professor in the Dept. of Communication Disorders and Sciences at Rush University. She currently serves on the Department of Defense Pharmaceutical Interventions for Hearing Loss Advisory Board, and was recently nominated to serve on ASHA’s Research and Scientific Affairs Committee (RSAC).

  • Sharon G. Kujawa, PhD

    Sharon G. Kujawa, PhD, is an Associate Professor of Otology and Laryngology, Harvard Medical School. She is Director of the Department of Audiology and a Senior Scientist in the Eaton-Peabody Laboratory, Massachusetts Eye and Ear Infirmary, Boston. She serves on the faculty of the Harvard Program in Speech and Hearing Biosciences and Technology. Work in the Kujawa Lab focuses on understanding how vulnerability to noise-induced hearing loss is shaped by genetic background, how noise exposure alters the way ears and hearing age, and how these consequences of exposure can be manipulated pharmacologically to reveal underlying mechanisms or for treatment or prevention.

  • Colleen LePrell, PhD

    Colleen LePrell, PhD, is an Associate Professor and Interim Chair of the Department of Speech, Language, and Hearing Sciences at the University of Florida, where she also directs the Center for Hearing Research. She has received research funding from the National Institutes of Health, Department of Defense, several foundations, and industry, for basic scientific research and translational studies assessing protection against temporary hearing loss in humans. Current research programs in her laboratory at the University of Florida include ongoing efforts to identify and prevent the progression of biochemical processes that lead to cell death in the inner ear, as well as industry-sponsored clinical research.

  • Lynne Marshall, PhD

    Lynne Marshall, PhD, is a Senior Research Audiologist at the Naval Submarine Medical Research Laboratory in Groton, Connecticut. She also is a Jayhawker from the University of Kansas, where she obtained master’s degrees in Speech Pathology and in Audiology, and a Ph.D. in Speech and Hearing Science. Following a clinical fellowship year in audiology at the Upstate Medical Center in Syracuse, New York, she spent several years in Omaha, Nebraska, where she was Clinical Coordinator of Audiology at the University of Nebraska Medical Center, a faculty member at the University of Nebraska, and also did postdoctoral work at Boys Town National Research Hospital. At the Naval Submarine Medical Research Laboratory she first did auditory sonar research, and now is focused on noise-induced hearing loss including the potential role of otoacoustic emissions in Hearing Conservation Programs, educational programs using hearing-loss simulation for Hearing Conservation applications, and decreasing noise-induced hearing loss in the Navy and Marine Corps.

  • Garnett P. McMillan, PhD

    Garnett P. McMillan, PhD, is biostatistician with the National Center for Rehabilitative Auditory Research at the Portland VA Medical Center. Dr. McMillan is an expert in computational statistics, statistical approaches to patient screening, diagnostic test development, linear and non-linear models, and Bayesian inference. He currently provides statistical support to over 30 projects funded by VA-RR&D, NIH, and industry sponsors spanning diverse topics such as tinnitus treatment, chemotherapy and cystic fibrosis management, sound localization, and the auditory epidemiology of multiple sclerosis, diabetes and Parkinson’s disease.

  • Judi Lapsley Miller, PhD

    Judi Lapsley Miller, PhD, is a hearing-research consultant, with a background in psychophysics, otoacoustic emissions, middle-ear power analysis, and hearing conservation. Her forte is experimental design and data analysis, and she is typically responsible for the bit in the middle of research papers - the method and results. Judi is based in Wellington, New Zealand.

  • Col Mark Packer, MD

    Col Mark Packer, MD, is the Executive Director for the Hearing Center of Excellence (HCE). He graduated from the Uniformed Services University of the Health Sciences in 1995 as a member of the Alpha Omega Alpha medical honor society. He completed a general surgery internship at Wright State University in Dayton, Ohio, in 1996, and was board certified in Otolaryngology Head and Neck surgery upon finishing his residency training in the San Antonio Uniformed Services Health Education Consortium in 2002. Most recently, he graduated from fellowship training in neurotology and cranial base surgery at The Ohio State University in 2008, and practices as a board certified Neurotologist within the San Antonio Military Health System.

  • Gayla L. Poling, PhD, CCC-A

    Gayla L. Poling, PhD, CCC-A, is a Research Audiologist in the Clinical Care, Rehabilitation and Restoration Directorate, Defense Hearing Center of Excellence, Contractor with The Geneva Foundation. She earned her M.A. in Speech and Hearing Science from The Ohio State University and completed her Clinical Fellowship at Henry Ford Hospital in Detroit, MI. She practiced as a clinical audiologist at the Mayo Clinic (Rochester, MN) prior to returning to Ohio State where she earned a Ph.D. in Hearing Science. She completed postdoctoral training focused on translational research at the Medical University of South Carolina and Northwestern University. Dr. Poling’s primary research interest is in the early detection and prevention of hearing loss due to noise and other environmental factors (ototoxicity).

  • Kedar N. Prasad, PhD

    Kedar N. Prasad, PhD, obtained a Master’s degree in Zoology from the University of Bihar in India, and a Ph.D. degree in Radiation Biology from the University of Iowa, Iowa City. He went to Brookhaven National Laboratory for Post-doctoral training. Dr. Prasad Joined the Department of Radiology at the University of Colorado medical School where he became Professor and the Director for the Center for Vitamins and Cancer Research. He published over 250 papers in peer-reviewed journals including Nature, Science, and Proceedings of the National Academy of Sciences (PNAS) supported by the NIH. He also contributed several book chapters and abstracts as well as authored or edited 25 books on radiobiology, neurodegenerative disease, and nutrition and cancer. He was a member of several professional organizations, and served as an ad-hoc member of various Study Sections of the NIH. He was a frequently invited speaker at National and International meetings on nutrition and cancer and neurological diseases. In 1982, he was invited by the Nobel Prize Committee to nominate a candidate for the Nobel Prize in Medicine. He delivered the 1999 Harold Harper Lecture at the meeting of the American College of Advancement of Medicine. He is a former President of the International Society for Nutrition and Cancer. Since 2005, he is Chief Scientific Officer of Premier Micronutrient Corporation.

  • Allen Ryan, PhD

    Allen Ryan, PhD, obtained a joint doctoral degree in neurophysiology and psychology from the University of Washington, studying the neural interface between hearing and behavior. He completed a postdoctoral fellowship in auditory neurobiology at Northwestern University, focused on the function of the outer hair cell. He then joined the Department of Otolaryngology at the University of California, San Diego and the San Diego VA Medical Center, where he directs programs in auditory research. A major focus is the cellular substrates of hearing loss, including cell death and survival signaling, molecular genetics and biology, the regulation of genes in hair cells and cochlear proteomics. A second area of research is the interface between cochlear neurons and hair cells, including neural contributions to hearing loss and the role of Type II spiral ganglion neurons. He has published over 340 journal articles and book chapters on these and other topics.

  • Martin Slade, MPH

    Martin Slade, MPH, is a Lecturer in Medicine and in Public Health at Yale University School of Medicine. He currently serves as the Director of Research for Yale Occupational & Environmental Medicine. He serves as a member of the Department of Defense Hearing Center of Excellence Pharmaceutical Interventions for Hearing Loss Working Group. Over the past 15 years, Mr. Slade has focused on the development of analytical models to evaluate the effects of physical, social, genetic and environmental factors on the patterns of disease and injury within the workplace setting, including non-traditional settings such as the military and merchant mariners. In recent years, he has been the lead statistician on four clinical trials conducted by the Department of Defense to determine the effect of pharmacological agents on prevention of hearing loss as well as mild traumatic brain injuries. More generally, he oversees the analyses required to deterministically model risk factors of occupational disease and injury.

Quick Fact

#18

On average, hearing aid users waited over 10 years after their initial diagnosis to be fitted with their first set of hearing aids.

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