Happenings on the Hill; OTC Hearing, EHDI Briefing, and Congressional Meetings
Tuesday, May 2nd was a big day for audiology advocacy on Capitol Hill. The House Energy and Commerce (E&C) Committee Subcommittee on Health held a hearing entitled “Examining Improvements to the Regulation of Medical Technologies.” The purpose of this hearing was for the Subcommittee to review several pieces of legislation related to the regulation of various medical technologies. The bills under examination could potentially be added to legislation that renews the Food and Drug Administration’s (FDA) user fee programs. One of the bills under review included the Over-the-Counter (OTC) Hearing Aid Act (H.R. 1652) introduced by Representatives Joe Kennedy (D-MA), Buddy Carter, (R-GA), and Marsha Blackburn (R-TN). Academy representatives had been meeting with key House staff in advance of the hearing to share the Academy’s perspective on the legislation. See the message from Academy President Ian Windmill for more details. At the hearing, Jeffrey Shuren, MD, JD, the Director for Devices and Radiological Health at the FDA, provided testimony. Thomas Powers, PhD, an audiologist from Powers Consulting, LLC provided testimony via an expert panel, as did Frank Lin, MD, PhD from the Johns Hopkins University. A full list of hearing witnesses is available here.
The hearing focused on the prevalence of hearing loss in the United States and examined barriers to access hearing aid devices, specifically cost. The Subcommittee questioned the panel experts on the safety and efficacy of creating a category of OTC devices. Dr. Shuren discussed that developing a category of OTC hearing aid devices would allow the FDA to implement better safeguards for consumers that may already be seeking products over-the-counter either through personal sound amplification products (PSAPs) or mail order devices. Subcommittee members questioned the consumer’s ability to self-diagnose their hearing loss and raised questions about how the FDA could ensure that consumers were purchasing a device that appropriately addressed their needs. There was also considerable discussion over the use of “mild to moderate” terminology in describing the hearing loss of the intended users of OTC devices.
Following the hearing, Academy staff joined Academy Government Relations Committee (GRC) member and pediatric audiologist, Mariah Cheyney, AuD, in meetings with Congressional representatives from Illinois. Dr. Cheyney traveled to Washington, DC to discuss the importance of early hearing detection and intervention (EHDI) programs and the pressing need to pass the EHDI bill (H.R. 1539, S. 652). She met with the offices of Senators Dick Durbin (D) and Tammy Duckworth (D), and Representative Randy Hultgren (R-IL 14th). Dr. Cheyney shared her experience working at Northern Illinois University and talked about the impact of existing EHDI programs in IL. The Senate HELP Committee approved this legislation last week, and we now await consideration of the bill by the full Senate. To contact your representatives about this legislation visit the Academy’s Legislative Action Center.
To further promote the importance of the EHDI bill on Capitol Hill, the Academy joined its colleagues in the Friends of the Congressional Hearing Health Caucus (FCHHC) in hosting a briefing luncheon in the US Capitol addressing the topic of identifying hearing loss in newborns. The co-chairs of the Congressional Hearing Health Caucus, Representatives David McKinley (R-WV) and Mike Thompson (D-CA), as well as the EHDI bill sponsor Representative Brett Guthrie (R-KY), spoke at this event and discussed the progress in different states with regard to early hearing detection and intervention for children diagnosed with hearing loss. The program also featured speakers from the National Institutes of Health (NIH), the National Institute on Deafness and Other Communication Disorders (NIDCD), the Health Resources and Services Administration (HRSA), and the Centers for Disease Control and Prevention (CDC). Kelly King, AuD, PhD, the speaker from the NIH, cited the success of current EHDI programs, but also noted that there is still a great need to address those children who are lost to follow-up. King called for further research to examine the reason for lost to follow-up- a key area that the EHDI bill will continue to help address.
The Academy continues to work with the FCHHC on planning future educational events for members of Congress, their staff, and other key policymakers and stakeholders. The next event will be an NIDCD/NIH tour in August.