Hearing Aid Imports

Hearing aid imports classify under HTS 9021.40 (hearing aids excluding parts and accessories) at base duty-free MFN. FDA OTC pathway (effective October 2022) reshaped the market. Section 122 stacks; Section 232 MedTech investigation pending. William Demant (Denmark), Sonova (Switzerland), GN Hearing (Denmark) dominant.

This guide covers U.S. import tariff and compliance for hearing aids.

For SMB importers in this category, the practical questions are HTS classification, applicable Section 232/301/122 stacks, FTA opportunities, and regulatory overlay (FDA/USDA/EPA/CPSC where relevant).

HTS classification basics

Hearing aids HTS 9021.40.00 (hearing aids, excluding parts and accessories). Parts under HTS 9021.40.20.

Tariff stack and rates

Base 0% + Section 122 (15% on non-USMCA). Effective 15%.

Country of origin considerations

Denmark, Switzerland, Germany dominant. Some Mexican USMCA assembly opportunity.

Regulatory overlay

FDA Class I (over-the-counter) or Class II (prescription) depending on type. Specific labeling requirements. EUDAMED for EU clearance overlay.

Mitigation opportunities

Some FTA preferences (Israel, Switzerland for specific products). USMCA qualification on Mexican-assembled units.

Frequently asked questions

What is the typical effective duty rate?

Depends on origin and HTS classification. China-origin: 22-42% effective when Section 301 + Section 122 stack. USMCA-qualifying Mexican production: often 0-3%. Vietnam, India, Korea: 15-17% with Section 122.

Can I qualify under USMCA?

Possible if production occurs in U.S., Mexico, or Canada and meets rules of origin (typically 60% RVC under transaction value or 50% net cost). USMCA-qualifying goods are exempt from Section 122.

Are IEEPA refunds available?

Yes – for entries between April 5, 2025 and February 24, 2026 that paid IEEPA duty. Filed through CBP’s CAPE portal. We file claims on contingency for filings above $50k.

What about Section 232 exposure?

Specific to product type. Steel and aluminum derivatives expansion brought some downstream products into scope. Component-level analysis identifies actual coverage.

How do you help with this category?

Tariff exposure assessment ($2,500-$7,500), classification audit, USMCA qualification, refund recovery, audit response. Independent of any customs brokerage.