510(k) · Cleared
ClearedBone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shokz Health Global Limited · LXB Hearing Aid, Bone Conduction
Cleared on Aug 19, 2026 as substantially equivalent to K161123 (Cochlear Americas, 2016) after a 322-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Aug 19, 2026
- Review
- 322 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K861971 (1986). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 5 generations between
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- This deviceK253431 Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400…Shokz Health Global Limited · 2026
Show all 9 generations
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 8 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 7 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 6 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 5 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 4 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK161123 Baha 5 Power Sound ProcessorCochlear Americas · 2016
- This deviceK253431 Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400…Shokz Health Global Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −8 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −6 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −5 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −4 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −3 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −2 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| −1 | K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016 | — |
| 0 (this device) | K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ… | Shokz Health Global Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
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 |
|---|---|---|---|
| * | K161123 | Baha 5 Power Sound ProcessorSummary page 6…evice Information Predicate device: Sponsor: Cochlear Americas Device: Baha 5 Power Sound Processor 510(K) Number: K161123 Reference device: Sponsor: Cochlear Americas Device: Cochlear Baha® SoundArc 510(… | 2016 |
| † | K171088 | Cochlear Baha SoundArc | 2017 |
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 40 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 21 ancestors has a recall of any class.
- 2 other devices also cite its predicate K161123.
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?
The device is intended to treat patients with hearing loss via bone conduction. The device is non-invasive bone conduction hearing device which is retained on the patient’s head.
Indications:
1)Patients above 6 years old with conductive or mixed hearing loss. The pure tone average bone conduction hearing threshold (measured at 0.5, 1, 2, and 4kHz) should be better than or equal to 60 dB HL.
2)Patients 18 years and older with sensorineural hearing loss. The pure tone average bone conduction hearing threshold (measured at 0.5, 1, 2, and 4kHz) should be better than or equal to 60 dB HL.
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/K253431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253431: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253431
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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