Legacy of Excellence Digital Flipbook

Chapter 5: 2017 – 2021

Academy leaders at the FDA in 2018 to present on clinical issues related to sleep disorders.

marketplace, the Academy noted that it was essential that patient experience and benefit are established from the outset. Further, the Academy highlighted the potential opportunity was high for citizens of the United States if done correctly, but it could also open the door for misuse. Throughout decades of advocacy, the Academy always sought a balance between access and safety. In the June 2017 Bulletin , Dr. Denneny noted, “As deregulation of the hearing aid industry progresses from discontinuation of the medical examination to over the-counter sales of entry-level devices, there will be a great propensity for patients with treatable causes of hearing loss to fall through the cracks. The public will need a trusted source that has the expertise and guiding principle of ‘best patient care’ to advocate for them and produce educational materials in a format that is both helpful and understandable to guide them through the system. We intend to be the trusted source for all areas of the specialty.” The Otolaryngologist and Sleep Disorders On April 16, 2018, the FDA convened a public workshop regarding the regulation of medical devices for sleep disordered breathing (SDB). The FDA was seeking to expedite innovation and patient access to sleep apnea devices. The AAO-HNS was invited by the FDA to serve as a key participant in the planning of the workshop,

joining other clinicians, device manufacturers, patients, and stakeholders. The specialty was well-represented at this public forum with the AAO-HNS team that included Kathleen L. Yaremchuk, MD, MSA; Raj Dedhia, MD; Dr. Denneny; M. Boyd Gillespie, MD, MSc; Stacey L. Ishman, MD, MPH; Ofer Jacobowitz, MD, PhD; and Edward M. Weaver, MD, MPH. Otolaryngologists chaired three of the four workgroups at the workshop. Other invited organizations included the American Academy of Neurology, the American College of Chest Physicians, the American Sleep Apnea Association, the American Academy of Sleep Medicine (AASM), and the American Academy of Dental Sleep Medicine. The FDA workshop marked a landmark success for otolaryngology-head and neck surgery, solidifying the specialty’s role in sleep medicine with patients, policymakers, and industry. It also furthered the Academy’s collaboration with the AASM and the American Board of Otolaryngology – Head and Neck Surgery (ABOHNS). In December 2019, under the leadership of ABOHNS Executive Director Brian Nussenbaum, MD, with the support of the AAO-HNS, ABOHNS proposed that otolaryngologists subcertified in sleep medicine have the opportunity to participate in CertLink™ and a process that fairly assessed their practice knowledge and skills. Dr. Nussenbaum followed a rigorous vetting process at the American Board of Medical Specialties

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