CTA’s OTC Hearing Aid Logo Running Out of Time at PTO

President Joe Biden’s executive order on promoting competitiveness in the U.S. economy (see 2107090010) directed Health and Human Services to propose rules by early November to create a category of affordable over-the-counter hearing aids for consumers with mild or moderate hearing loss. But CTA’s efforts to land approval of a certification mark identifying OTC hearing aids compliant with a 2017 industry performance standard appear to be running out of time at the Patent and Trademark Office. CTA is entitled by July 27 to request a fifth and final six-month deadline extension for filing a statement of use on the logo, but risks abandonment of the application if it produces no SOU by late January. SOUs, the last step in the registration process, describe how conditionally approved trademarks are being deployed commercially. PTO requires them to prevent applicants from hoarding trademarks, but CTA is hamstrung from filing the SOU because no categories of OTC hearing aids can exist before the Food and Drug Administration approves final rules creating them. The statutory deadline for proposing OTC rules under the FDA Reauthorization Act of 2017 is nearly a year overdue. “Creating the rules for OTC hearing aids so consumers can benefit from lower-cost options is most important,” emailed Brian Markwalter, CTA senior vice president-research and standards. CTA and its members created ANSI/CTA-2051, the Personal Sound Amplification Performance Criteria Standard, “to provide performance metrics and target values for OTC hearing aids that could work alongside and support FDA rules,” said Markwalter on Monday. “We will take up the need for a certification mark based on the CTA standard with our members as the rulemaking process unfolds.” Section 709 of the 2017 statute gave the FDA three years from date of enactment to propose OTC rules. The agency last summer blamed COVID-19 workloads for missing the Aug. 18, 2020, deadline, but said then that OTC hearing aids remained "a priority" (see 2008200024). Section 709 is silent on how long the rulemaking's notice and comment period should last, but requires the FDA to publish final rules creating the OTC category no later than 180 days after comments close.