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510(k) K261256

Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) by Shenzhen Magnet Technology Co., Ltd. — Product Code LXB

K261256 is an FDA 510(k) premarket notification submitted by Shenzhen Magnet Technology Co., Ltd. for the device "Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
April 16, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Bone Conduction
Device Class
Class II
Regulation Number
874.3302
Review Panel
EN
Submission Type

Other clearances for product code LXB

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  • K243041 — contact forte Alpha (April 25, 2025)
  • K213733 — Ponto 5 SuperPower (December 16, 2021)
  • K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma (September 29, 2021)
  • K211640 — Ponto 5 Mini (August 10, 2021)
  • K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear (February 23, 2021)
  • K190540 — Ponto 4 (May 2, 2019)
  • K172460 — ADHEAR System (April 27, 2018)
  • K171088 — Cochlear Baha SoundArc (June 7, 2017)

FDA data resources