510(k) · Cleared
ClearedAudiant Bone Conductor or a.B.C.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Apr 3, 1986 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 3, 1986
- Review
- 106 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK855059 Audiant Bone Conductor or a.B.C.Xomed, Inc. · 1986
- Descendant · cites it directly · 4 of its ownK102199 Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1…Sophono, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK132189 Otomag Bone Conducation Hearing SystemSophono, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK153391 Sophono Bone Conduction Systems (S) Configuration and (M)…Sophono, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK243041 contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025
- Descendant · 2 generations on · 0 of its ownK123962 Otomag Bone Conduction Hearing SystemSophono, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K102199Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Sophono, Inc. · 2011 · cites it directly4descendants
- K132189Otomag Bone Conducation Hearing SystemSophono, Inc. · 2013 · 2 generations on2descendants
- K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc. · 2016 · 3 generations on1descendant
- K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025 · 4 generations on0descendants
- K123962Otomag Bone Conduction Hearing SystemSophono, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K855059 | Audiant Bone Conductor or a.B.C. | Xomed, Inc. | 1986 | — |
| +1 | K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) | Sophono, Inc. | 2011 | — |
| +2 | K132189 | Otomag Bone Conducation Hearing System | Sophono, Inc. | 2013 | — |
| +3 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016 | — |
| +4 | K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025 | — |
| +2 | K123962 | Otomag Bone Conduction Hearing System | Sophono, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) | 2011 | 4 |
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?
- Of its descendants, K102199 (Sophono, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K855059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K855059: Audiant Bone Conductor or a.B.C..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K855059
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026