In recent weeks, you probably have been following the federal legislative activities to create a new category of over-the-counter (OTC) hearing aids. In our last FLAA Communication, we explained:
U.S. Senate Bill S. 670, Over the Counter Hearing Aid Act (2017) was introduced by Senator Elizabeth Warren (D-MA) with current co-sponsors Senators Chuck Grassley (R-IA), Margaret W. Hassan (D-NH), and Johnny Isakson (R-GA). There is a companion bill in the U.S. House of Representatives, HR 1652, introduced by Representatives Joseph Kennedy III (D-MA), Marsha Blackburn (R-TN), and Earl Buddy Carter (R-GA). The bill now has a total of 8 co-sponsors-none from Florida.
The rumors circulating around Washington is that the OTC legislation may be attached to the FDA Reauthorization Act of 2017 which is a broad legislative package that must be passed by 30 September to renew the FDA’s authority to collect user fees from manufacturers of prescription drugs, medical devices, and generic drugs among others. This would reauthorize the collection of fees that are critical to the funding of FDA and requires reauthorization every 5 years. If the OTC bill is attached to the FDA Reauthorization Act this would greatly increase the chance of the OTC bill clearing the US House of Representatives. At this point it is unclear whether the OTC bill will also be attached to the US Senate version of FDA Reauthorization Act of 2017.
Key aspects of the Over-the-Counter Hearing Aid Act of 2017 The bill:
- -Intends to establish a category of hearing aids for the treatment of mild-to-moderate hearing loss available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.
- -Will remove the requirement that consumers obtain a medical evaluation or sign a waiver of that examination to obtain an OTC hearing aid
Requires the FDA to issue regulations on safety and labelling requirements for the new category of OTC hearing aids
- -Aims to maintain existing safety, labelling, and manufacturing protections and applies them to OTC devices to ensure that OTC hearing aids are held to the same standards as other medical devices.
- -Calls on the FDA to update and finalize is draft guidance on “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products” to clarify the distinction between medical devices and PSAPs.
In addition to the OTC legislative activities, last week, the Federal Trade Commission (FTC) had their hearings with panelists from across the hearing community including manufacturing, professional associations, and consumer groups. A video and speaker slides are available to view at: https://www.ftc.gov/news-events/audio-video/2017-workshops
The FTC also is seeking input from anyone with the time and interest to write. You can submit a comment at:
If you want to read comments that already have been submitted: https://www.ftc.gov/policy/public-comments/initiative-690
You are encouraged to write to the FTC as well as sponsors of the legislation. We will continue to provide updates as they arise.
Barry A. Freeman, Ph.D., VP Legislative Activities