The Food and Drug Administration (FDA) Spring 2021 regulatory agenda indicates the agency could as soon as this month release its long-awaited proposed rule to establish an over-the-counter (OTC) category of hearing aids. This would lay out safety, labeling, and manufacturing standards for the devices, coming as key lawmakers press the Department of Health and Human Services (HHS) to get the regulation out.
The regulatory agenda, released Friday, June 11, says the FDA expects to publish the proposed rule, “Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations,” in June.
The FDA was supposed to publish the proposed rule in August 2020, per the 2017 FDA Reauthorization Act, but missed the deadline. Senators Warren and Grassley have pressed the FDA multiple times since August 2020 to prioritize the release of these proposed regulations.
In November 2020, Senator Warren and Senator Grassley wrote an official letter inquiring about the status of these proposed regulations. In a recent Senate Finance Committee hearing on June 10, Senator Grassley pressed HHS Secretary Becerra for an update on the status of the regulations.
The Academy will continue to monitor this situation very closely.
The Audiology Quality Consortium (AQC), currently chaired by the Academy, submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding changes to audiology quality measures and reporting responsibilities under the Merit-Based Incentive Payment System (MIPS). The mission of the AQC is to: Collaborate on the analysis and recommendation of audiology quality measures for use in…
The current FTC Guides state that “endorsers qualifications must in fact give the endorser the expertise that the endorser is represented as possessing with respect to the endorsement.” The proposed modification of an illustrative example in the Guides implies that an endorser of a hearing aid should not be referred to as “Doctor” as this…
Over-the-Counter (OTC) Hearing Aid Final Rule: Existing State Medical Clearance Requirements and “Prescription” Terminology
The Academy submitted a letter to the Federal Drug Administration (FDA) requesting clarification on two critical issues included in the final OTC rule to ensure the final rule can be implemented in an expeditious manner. Many state audiology licensing laws currently include a requirement that an individual receive medical clearance or sign a document waiving…