Over-the-Counter Hearing Aid Legislation and Regulatory Action

Over-the-Counter Hearing Aid Legislation and Regulatory Action

Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA), along with Senators Maggie Hassan (D-NH), and Johnny Isakson (R-GA), introduced the Over-the-Counter Hearing Aid Act of 2017 (S. 670). A companion bill (H.R. 1652) was introduced in the House by Representatives Marsha Blackburn (R-TN) and Joe Kennedy (D-MA). The Academy has been actively engaged on this legislation since the start of the 115th Congress and was able to see several key changes made to the original version of the bill that was introduced at the end of the 114th Congress. The Academy’s conversations with lawmakers were based on its two statements addressing OTC Devices and Accessibility and Affordability for Hearing Care.

This legislation was included as a provision in the FDA Reauthorization Act that was passed on August 3, 2017. Read more about the passage of the FDA Reauthorization Act here. The Academy will continue to work with the FDA to develop over-the-counter hearing aid regulations to be implemented over the coming months and years. The Academy prepared  recommendations for consideration by the FDA in advance of the formal rule-making process.

Academy President Ian Windmill Addresses OTC Hearing Aid Legislation

 Issue Brief

Academy Statement: Over-the-Counter Devices

Senate Version (S. 670)

House Version (H.R. 1652)

Regulatory Actions