Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)— 510(k) K261256
Substantially EquivalentShenzhen Magnet Technology Co., Ltd.
FDA 510(k) clearance K261256 for Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3), Substantially Equivalent on 2026-06-11. Applicant: Shenzhen Magnet Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Magnet Technology's Bone Conduction Hearing Aid is listed in three models, XTS-AISW-D1, XTS-AISW-D2, and XTS-AISW-D3. It's filed under LXB, bone conduction hearing aids, and the record doesn't say how the models differ.
Class II, 21 CFR 874.3302. Ear, Nose, and Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Magnet Technology filed from Shenzhen, China. Review took 56 calendar days (April 16 to June 11, 2026).
Clearance details
- Applicant
- Shenzhen Magnet Technology Co., Ltd.
- Product code
- Product code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code LXB
view all- K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- K254296 — Ossiclear (Ossiclear System)
- K260452 — 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)
- K250215 — Baha 7 Sound Processor +4 more
- K243041 — contact forte Alpha
Adverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.