FDA Finalizes Rule for Over-the-Counter Hearing Aids

Medmarc Insurance Group

September 8, 2022

The FDA released the final rule for over-the-counter (OTC) hearing aids, which the agency said may assist nearly 30 million Americans in obtaining safe and effective devices at a lower cost than devices that are currently available. The rule goes into effect 60 days after the Aug. 16, 2022, announcement for any new 510(k) applications, but manufacturers with devices already on the market have 240 days to come into compliance with this new rule.

The Over-the-Counter Hearing Aid Act of 2017, part of the FDA Reauthorization Act of the same year, mandated that the agency develop a regulation drastically expanding the availability of OTC hearing aids. The legislation required the FDA to complete the rulemaking process by the end of 2020, a timeline that was made difficult by the COVID-19 pandemic. The Biden administration forced the agency to act in a July 2021 executive order directed to several economic competitiveness issues. The section addressing OTC hearing aids left the FDA with 120 days to publish a draft rule, and the FDA said it had received more than 1,000 comments on the October 2021 draft.

The final rule lowers the maximum sound output of OTC devices to 111 decibels of sound pressure level (dB SPL), a change made from the draft to further reduce the risk of damage to the ear from overamplified sound. The final rule also requires that devices offer the user a method for adjusting output volume, and limits the depth of device penetration into the ear canal to no closer than 10 millimeters from the tympanic membrane.

The rule creates an OTC device category for mild to moderate hearing loss in those aged at least 18 years, but the final rule will not require age verification for purchases, which can be transacted online and in retail establishments. There is no requirement that devices sold under this rule be self-fitting hearing aids. The FDA said it is not dismissive of the role of hearing professionals in ensuring a device was appropriately selected and fitted, and said it supports patient interaction with professionals to help determine the degree of hearing loss and device selection and fit. While there were commenters who recommended that steps be taken to increase the availability of hearing professionals rather than allow hearing aids to become OTC products, the agency said such considerations are outside its purview.

The final rule is preemptive of any state law impeding OTC access to hearing aids, although state laws regarding servicing and warranties are not preempted. The FDA said the rule establishes a new regulatory category for OTC devices and is accompanied by a guidance distinguishing between OTC hearing aids and personal sound amplification products (PSAPs). The guidance, an updated version of a guidance released in 2009, acknowledges the confusion over how the FDA makes the distinction between PSAPs and hearing aids, but states that the objective intent of a manufacturer in describing the device is a key consideration.

Any statements that explicitly or implicitly claim that a product improves or mitigates hearing loss or impaired hearing causes the product to be deemed a hearing aid rather than a PSAP. The guidance gives several examples of claims rendering the product a hearing aid, such as any suggestion that the product is indicated for use in situations that are typically associated with and indicative of hearing loss or impaired hearing. Any suggestions that the product is an alternative to a hearing aid would similarly take the regulatory status out of the category of a PSAP.

The guidance clarifies that PSAPs are intended to accentuate sounds in specific listening environments for those who do not suffer from impaired hearing. Because such products are not intended to diagnose or treat a disease or condition, they are not subject to FDA regulation, although they are subject to the related provisions of the Radiation Control for Health and Safety Act of 1968.

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