FDA's 2022 OTC hearing aid rule established a separate regulatory category for devices intended for adults with perceived mild-to-moderate hearing loss, with distinct labeling and performance standards. Prescription hearing aids remain subject to traditional 510(k) clearance and dispensing requirements. Importers must correctly identify which category their product falls into, as the applicable FDA requirements—and therefore the admissibility documentation—differ between the two.

Hearing aids sourced from certain countries, including China, may be subject to Section 301 tariffs. Because hearing aids are classified as medical devices, some importers have sought exclusions or explored alternative sourcing in countries not subject to these measures. Importers should verify the current tariff treatment for their specific product and country of origin at the time of entry.