Clinicians Push Back on FDA's Proposed OTC Hearing Aids Rule

Though comments aren't due until Jan. 18 in the Food and Drug Administration’s rulemaking to create a category of affordable over-the-counter hearing aids for U.S. adults with mild to moderate hearing loss, audiologists and other clinicians have already begun voicing concerns that the agency’s proposed OTC hearing aids rule poses risks to consumers’ health and safety.

Hearing loss affects an estimated 30 million people in the U.S. “and can have a significant impact on communication, social participation, and overall health and quality of life,” said the FDA’s Oct. 20 OTC rulemaking notice. “Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention,” it said, citing the high costs of prescription devices among several “barriers” to adoption. "We believe the proposals set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology."

The FDA proposed setting a maximum output level of 115 dB of amplification on OTC hearing aids “as a general rule to balance consumer safety with device performance” but would permit a 120 dB maximum on devices with a user-adjustable volume control, it said. The parameters are generally in line with those of the Personal Sound Amplification Performance Criteria standard (ANSI/CTA-2051) approved by the American National Standards Institute and CTA in January 2017. ANSI/CTA-2051 is available for free download at the CTA store.

The agency shunned proposing limits on a device’s “gain” -- defined as the ratio between its output and input -- because “the proposed maximum output limit (together with the other proposed requirements) will provide reasonable assurance of safety and effectiveness,” it said. It also worried that mandating a gain limit “may unduly constrain the design of effective devices,” and that “appropriate gain settings for one device may not be appropriate for another device of a different design,” it said.

Those attributes didn’t sit well with audiologist Kristen Kramer, who believes “proper guardrails must be in place to protect and best assist an individual’s hearing,” she commented Friday in docket FDA-2021-N-0555. She wants the agency to impose gain limits of 25 dB in OTC devices and lower their maximum allowed output to 100 dB, she said. Her comments typified dozens filed since the rulemaking notice, many from clinical professionals urging the agency to rethink its decisions on maximum output levels and gain limits.

Kramer also wants “enhanced enforcement mechanisms” in the rule “to prevent sales to minors,” and asked the FDA to adopt “labeling validation to ensure users can accurately self-diagnose their level of hearing loss,” she said. “As a hearing healthcare professional,” said Kramer, “I am personally committed to ensuring each patient who comes through my door is informed and confident in the decisions we make" on hearing loss. She fears OTC hearing aids risk costing consumers “significantly more” to their personal health and safety than OTC reading glasses for vision loss, she said.

The FDA’s omission of a gain limit in OTC hearing aids “could distort speech and lead to overamplification in devices intended for mild to moderate hearing loss,” commented Columbia University ear, nose and throat specialist Anil Lalwani. “If the amount of gain present in the amplifier is too high, it will overload, saturate and distort the input signal causing distortion for the user,” he said last month. Omitting a gain limit “is especially problematic because it could make the device not safe for extended use on a daily basis,” he said. “What is the point of making a device accessible if it is bound to be ineffective and unsafe?”

President Joe Biden’s July 9 executive order said the FDA should “promote the wide availability of low-cost hearing aids” by putting the proposed rule out for comment within 120 days after the agency missed its August 2020 rulemaking deadline for creating the OTC category under the 2017 FDA Reauthorization Act (see 2107100001).

CTA applied in June 2018 to trademark a certification logo for OTC hearing aids compliant with ANSI/CTA-2051, but the delay cost CTA its certification mark when it became clear the association would be unable to demonstrate the logo’s deployment in commercial products, as the Patent and Trademark Office required, by next month’s statutory deadline. CTA’s application died Aug. 30 after the association decided to forego a fifth and final deadline extension request for submitting a statement of use.

The FDA’s Oct. 20 rulemaking notice proposed making the final OTC hearing aid rule effective 60 days after its publication in the Federal Register. CTA didn’t comment Monday about whether it plans to resurrect the logo application, and when.