Cleared Traditional

Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (K261256) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K261256 · Shenzhen Magnet Technology Co., Ltd. · Ear, Nose, Throat device
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Jun 2026
Decision
56d
Days
Class 2
Risk

K261256 is an FDA 510(k) clearance for the Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3). Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Shenzhen Magnet Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 11, 2026 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Magnet Technology Co., Ltd. devices

Submission Details

510(k) Number K261256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date June 11, 2026
Days to Decision 56 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 89d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 8
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