Welcome to OTC Hearing Aids and PSAPS: Implications of the PCAST - PowerPoint PPT Presentation

Welcome to OTC Hearing Aids and PSAPS: Implications of the PCAST and NAS Reports Presenter: Alissa Parady Director of Government Affairs International Hearing Society IHS Organizers Ted Annis Fran Vincent Marketing and Membership Manager Senior Marketing Specialist

Housekeeping  This presentation is being recorded  CE credit is available! Visit ihsinfo.org for details  Note taking handouts are available at ihsinfo.org on the webinar page. Feel free to download now!

Agenda  PCAST  NAS  FDA  What’s Next?  Q&A (enter your questions in the Question Box any time)

PCAST Report – Oct 2015 FDA NAS Committee Report - Jun 2016

President’s Council of Advisors on Science and Technology

President’s Council of Advisors on Science and Technology Co-Chairs Christine Cassel,** National Quality Forum Ed Penhoet,** Alta Partners Members Rosina Bierbaum,** University of Michigan David Lindeman, CITRIS Jo Ivey Boufford, New York Academy of Chad Mirkin,** Northwestern University Medicine Craig Mundie,** Mundie & Associates Sara Czaja, University of Miami Beth Mynatt, Georgia Tech David Dring, Selfhelp William Press,** University of Texas at S. James Gates, Jr,** University of Maryland, Austin College Park Maxine Savitz,** Honeywell (retired) Susan Graham,** University of California, Charlotte Yeh, AARP Berkeley Art Kramer, University of Illinois Thomas Kamber, Older Adults Technology Services **Denotes PCAST member Jason Karlawish, University of Pennsylvania

President’s Council of Advisors on Science and Technology  Emphasis on older adults with age-related hearing loss  Focus on hearing loss, associated health concerns, the current delivery model and perceived innovations, with goal of growing accessibility to hearing technologies  Hearing aids = Readers and smartphones?  Regulatory framework questioned  PCAST’s purview

PCAST Recommendations 1. FDA should designate as a distinct category “basic” hearing aids—non-surgical, air-conduction hearing aids intended to address normal, bilateral, gradual onset, mild-to-moderate age-related hearing loss—and adopt distinct rules for such devices. 2. FDA should withdraw its draft guidance of November 7, 2013 on Personal Sound Amplification Devices (PSAPs).

PCAST Recommendations 3. Analogously to its “Eyeglass Rule,” FTC should require audiologists and hearing-aid dispensers who perform standard diagnostic hearing tests and hearing aid fittings to provide the customer with a copy of their audiogram and the programmable audio profile for a hearing aid at no additional cost and in a form that can be used by other dispensers and by hearing-aid vendors. 4. Similarly in effect to its “Contact Lens Rule,” FTC should define a process by which patients may authorize hearing aid vendors (in-state or out-of- state) to obtain a copy of their hearing test results and programmable audio profile from any audiologist or hearing-aid dispenser who performs such a test, and it should require that the testers furnish such results at no additional cost.

IHS to PCAST “IHS is aware of no evidence to support the efficacy or safety of these recommendations, nor the existence of evidence that they would positively impact responsible accessibility, cost, or the use of hearing aids in a meaningful way.”

National Academies of Science, Engineering, and Medicine Committee on Accessible and Affordable Hearing Care for Adults  Agency funded  Workshop  Five public meetings  Deep dive

National Academies of Science, Engineering, and Medicine Dan G. Blazer (Chair), Duke University William R. Hazzard, Wake Forest University School of Medicine Brenda Battat, Independent Consultant Frank R. Lin, Johns Hopkins University Karen J. Cruickshanks, University of Wisconsin Medical School Nicole Marrone, University of Arizona Jennifer E. Devoe, Oregon Health & José A. Pagán, New York Academy of Science University Medicine Judy R. Dubno, Medical University of Thomas Pippin (Retired), Wisconsin Hearing South Carolina Aids, Inc. Richard Ellenson, Cerebral Palsy Katherine D. Seelman, University of Foundation Pittsburgh Barbara J. Evans, University of Houston Debara L. Tucci, Duke University Ellen J. Flannery, Covington & Burling, David A. Zapala, Mayo Clinic Florida LLP Darrell J. Gaskin, Johns Hopkins Bloomberg School of Public Health

NAS: IHS Participation HAS on Committee HAS Panelist Int’l HAS Panelist

NAS: IHS Participation IHS has taken the work of the committee very seriously  Sent comments in January 2016  Highlighted concerns with PCAST report  Made series of recommendations  Awareness  Identification  Access

U.S. Food and Drug Administration Activity Personal Sound Amplifiers  Reopened comment period on 2013 Guidance for Industry and Staff on Personal Sound Amplifiers vs. Hearing Aids  Comment period closed 5/6/16 Over the Counter Hearing Aids  April 21 Workshop/comment period on OTC classification  OTC hearing tests leading to self-diagnosis, self-fitting (self-treating), self- monitoring  Third party organization conducting standardization and quality review  Comments due 6/30/16

FDA Workshop 4/21 Workshop: Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm

FDA Workshop Evidence  Japanese Model  Continued innovation  Value of Red Flags/medical clearance unchanged  Increasing co-morbidities  Colorado deregulation

NAS Report

NAS Report Findings  Hearing is vital to communications, health, function, and quality of life. Individuals need to be alert to their hearing health, as hearing loss can range from mild to profound and tends to increase with age, onset can be gradual, and each individual’s hearing needs are unique.  Hearing health care involves a wide range of services and technologies with ever-expanding and evolving options; however, many people do not have access to these options or cannot afford them.  Hearing loss is a public health and societal concern; engagement and action are needed across the spectrum of relevant stakeholders, including individuals and families, professionals, nonprofit organizations, industries, government, and the health care community.

NAS Goal 1: Improve Population-Based Information on Hearing Loss and Hearing Health Care The National Institutes of Health, the Centers for Disease Control and Prevention, the Patient-Centered Outcomes Research Institute, the Department of Defense, the Department of Veterans Affairs, state public health agencies, and other relevant government agencies, as well as nonprofit organizations, hearing health care professional associations, academic institutions, and researchers, should strengthen efforts to collect, analyze, and disseminate prospective population-based data on hearing loss in adults and the effects of hearing loss and its treatment on patient outcomes. Specifically….

NAS Goal 1: Improve Population-Based Information on Hearing Loss and Hearing Health Care  Support and conduct studies to develop, evaluate, strengthen, and align metrics for hearing loss and communication abilities;  Support and conduct studies, including longitudinal studies, in diverse populations to better understand: – the risk and natural history of hearing loss; – risk factors and co-morbidities of hearing loss; – hearing health care needs; and – the impact of hearing loss and its treatment on health, function, economic productivity, and quality of life; and  Develop and strengthen research training programs to address hearing loss as a public health concern with attention to cross-disciplinary training on sensory disorders, epidemiological methods, advanced biostatistics, and health services and health economics research methods.

NAS Goal 2: Develop and Promote Measures to Assess and Improve Quality of Hearing Health Care Services The Centers for Medicare & Medicaid Services, the National Institutes of Health, the Department of Defense, the Department of Veterans Affairs, other relevant federal agencies hearing health care professional associations and providers, advocacy organizations, health care quality improvement organizations, health insurance companies, and health systems should collaborate to:  Align and promote best practices and core competencies across the continuum of hearing health care, and implement mechanisms to ensure widespread adherence; and  Research, develop, and implement a set of quality metrics and measures to evaluate hearing health care services with the end goal of improving hearing- and communication-focused patient outcomes.

NAS Goal 3: Remove FDA Regulation for Medical Evaluation or Waiver The Food and Drug Administration should remove the regulation that an adult seeking hearing aids be required to first have a medical evaluation or sign a waiver of that evaluation and should ensure consumers receive information about the medical conditions that could cause hearing loss through continued inclusion of that information in hearing aid user instructional brochures.