Cleared Traditional

K261256 - Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

K261256 is an FDA 510(k) clearance for Bone Conduction Hearing Aid (XTS-AISW-D1, manufactured by Shenzhen Magnet Technology Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code LXB cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K261256 · Shenzhen Magnet Technology Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K261256

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 90d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LXB Device Classification - Class 2, Special Controls

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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Riley Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LXB Hearing Aid, Bone Conduction

All 51
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K261256.
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
K253431 · Shokz Health Global Limited · Aug 2026
Ossiclear (Ossiclear System)
K254296 · Sounduct · Jul 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
K260452 · Zdeer Technology (Henan) Co., Ltd. · Jun 2026
Baha 7 Sound Processor
K250215 · Cochlear · May 2025
contact forte Alpha
K243041 · Bhm-Tech Produktionsgesellschaft Mbh · Apr 2025
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K213733 · Oticon Medical AB · Dec 2021