510(k) · Cleared
ClearedBone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Magnet Technology Co., Ltd. · LXB Hearing Aid, Bone Conduction
Cleared on Jun 11, 2026 as substantially equivalent to K121793 (Audifon-USA, Inc., 2012) after a 56-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 11, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935701 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK935701 Viennatone an, Viennatone as Fidelity F228, Fidelity F229Starkey Laboratories, Inc. · 1994
- 1 generation backK121793 AN Evo 1, CS Evo 1, Contact Mini, ApollonAudifon-USA, Inc. · 2012
- This deviceK261256 Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935701 | Viennatone an, Viennatone as Fidelity F228, Fidelity F229 | Starkey Laboratories, Inc. | 1994 | — |
| −1 | K121793 | AN Evo 1, CS Evo 1, Contact Mini, Apollon | Audifon-USA, Inc. | 2012 | — |
| 0 (this device) | K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LXB device
- #1 K254296 Ossiclear (Ossiclear System)score 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121793 | AN Evo 1, CS Evo 1, Contact Mini, ApollonSummary page 5…Predicate Device Manufacturer 510(k) Number Product code Bone conduction hearing aid BHM-Tech K121793 LXB IV. Device Description The bone conduction hearing aid is intended as hearing compensation of bone conductio… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K121793.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LXB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LXB
79in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXB
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXB
261in 2025
MAUDE reports naming product code LXB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 110 |
| 2009 | 2 | — | 0 | 76 |
| 2010 | 2 | — | 0 | 91 |
| 2011 | 5 | 189 | 0 | 123 |
| 2012 | 1 | — | 5 | 346 |
| 2013 | 5 | 103 | 0 | 640 |
| 2014 | 0 | — | 0 | 545 |
| 2015 | 2 | — | 0 | 824 |
| 2016 | 4 | 110 | 0 | 692 |
| 2017 | 1 | — | 0 | 379 |
| 2018 | 1 | — | 1 | 336 |
| 2019 | 1 | — | 0 | 497 |
| 2020 | 0 | — | 0 | 547 |
| 2021 | 4 | 79 | 0 | 490 |
| 2022 | 0 | — | 0 | 387 |
| 2023 | 0 | — | 0 | 348 |
| 2024 | 0 | — | 0 | 232 |
| 2025 | 2 | — | 0 | 261 |
| 2026 | 4 | 164 | 0 | — |
What is it indicated for?
Bone Conduction Hearing Aid (models: XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) is wearable sound-amplifying device intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional. The device is intended for adults and children (=12 years).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261256: Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261256
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026