510(k) · Cleared
ClearedSecond Ear Bone Conduction Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wordcomp International Communication Group (Wicg) · LXB Hearing Aid, Bone Conduction
Cleared on Apr 12, 1996 as substantially equivalent to K884288 (Unitron Industries, Inc., 1989) and 1 other predicate after a 239-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Apr 12, 1996
- Review
- 239 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884288 (1989). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884288 Hearing Aid, Unitron Bte Model UM60-AGC0Unitron Industries, Inc. · 1989
- This deviceK953872 Second Ear Bone Conduction Hearing AidWordcomp International Communication Group (Wicg) · 1996
- Descendant · cites it directly · 2 of its ownK050653 Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK100649 Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK110831 Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K050653Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005 · cites it directly2descendants
- K100649Soundbite Hearing System by SonitusSonitus Medical, Inc. · 2011 · cites it directly1descendant
- K110831Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884288 | Hearing Aid, Unitron Bte Model UM60-AGC0 | Unitron Industries, Inc. | 1989 | — |
| 0 (this device) | K953872 | Second Ear Bone Conduction Hearing Aid | Wordcomp International Communication Group (Wicg) | 1996 | — |
| +1 | K050653 | Transear Bone Conduction Hearing Aid | United Hearing Systems, Inc. | 2005 | — |
| +1 | K100649 | Soundbite Hearing System by Sonitus | Sonitus Medical, Inc. | 2011 | — |
| +2 | K110831 | Soundbite Hearing System by Sonitus Medical | Sonitus Medical, Inc. | 2011 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K884288 | Hearing Aid, Unitron Bte Model UM60-AGC0Summary page 4…del Device Class 1] 1l I Il Yes Manufacturer: WORDCOMP INTERNAT. Unitron Radioear Starkey Labs, Inc. Yes Classification Code: 77L.XB Same Same Same Yes K-Number Pending K884288 Unknown K923784 NA david/ear3.doc 14 | 1989 |
| * | K923784 | Starkey SM Series Bte Hearing AidsSummary page 4…s 1] 1l I Il Yes Manufacturer: WORDCOMP INTERNAT. Unitron Radioear Starkey Labs, Inc. Yes Classification Code: 77L.XB Same Same Same Yes K-Number Pending K884288 Unknown K923784 NA david/ear3.doc 14 | 1992 |
| * | — | Radioear B70 Series Audio Transducers Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 | — |
What is it indicated for?
Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms
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/K953872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953872: Second Ear Bone Conduction Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953872
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026