Legacy of Excellence Digital Flipbook

Chapter 4: 2012 – 2016

On the regulatory side of federal activity, in 2013 the Food and Drug Administration (FDA) announced a decision to issue a “box warning” for the use of codeine as an analgesic following tonsillectomy and adenoidectomy in children. Establishing itself as the go-to source in these areas, the Academy was contacted by the FDA as a source of expertise and knowledge in this decision-making. The AAO

recommended that the Hybrid L24 was safe, effective, and provided benefits that outweighed the risks for patients meeting the criteria specified in the proposed indications. Examining the Accessibility and Affordability of U.S. Hearing Healthcare During this timeframe, several Administration-related entities were examining the topic of “access to hearing healthcare services and/or devices,” and what steps could be taken to mitigate perceived barriers associated with accessing such services. The AAO-HNS was an active participant as this multifaceted investigation evolved by providing feedback and/or comments to the President’s Council of Advisors on Science and Technology (PCAST), the National Academies of Medicine (NAM), and FDA. Provided below is a brief overview of the Academy’s efforts on behalf of members, their practices, and their patients: President’s Council of Advisors on Science and Technology (PCAST) – In October 2015, the PCAST issued a report titled, “Aging America & Hearing Loss: Imperative of Improved Hearing Technologies” that outlined the advisory group’s recommendations for broadening access to various hearing aid and/or hearing aid-like devices in the United States, including the potential for “over-the-counter” sale of certain hearing aids.

2015: AAO-HNS worked with the American Institute for Ultrasound Medicine (AIUM) to develop a mutual accreditation pathway in head and neck ultrasound.

HNS PSQI Committee, on behalf of the Academy, was instrumental in working with the FDA on members’ behalf. The FDA agreed to co-author a commentary with PSQI Committee Co-chair, David W. Roberson, MD, and Dr. Nielsen, which was published in the New England Journal of Medicine . Also in 2013, the FDA Ear, Nose, and Throat Devices Panel (ENT Panel) met in Silver Spring, Maryland, on November 3, to discuss the safety and effectiveness of a new hybrid cochlear impact device, the Nucleus Hybrid L24 Implant System. The goal was to decide about pre-market approval status. Several Academy leaders had prominent roles with the FDA. Notably, Gayle E. Woodson, MD, served as chair of the FDA ENT panel along with Academy member Anjum Khan, MD, MPH. After deliberation, the ENT panel unanimously

2015: To facilitate its grassroots outreach, the BOG updated its committee charges, online resources, bylaws, and society application process.

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