510(k) · Cleared
ClearedOtomag Bone Conducation Hearing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sophono, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Nov 22, 2013 as substantially equivalent to K102199 (Sophono, Inc., 2011) after a 130-day review. Its family tree reaches back 8 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K861971 (1986). 22 ancestors in all, the oldest K855059 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 7 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 6 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 5 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 4 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 3 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 2 generations backK100193 Otomag Bone Conduction Hearing SystemSophono, Inc. · 2010
- 1 generation backK102199 Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1…Sophono, Inc. · 2011
- This deviceK132189 Otomag Bone Conducation Hearing SystemSophono, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK153391 Sophono Bone Conduction Systems (S) Configuration and (M)…Sophono, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK243041 contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −7 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −5 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −4 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −3 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −2 | K100193 | Otomag Bone Conduction Hearing System | Sophono, Inc. | 2010 | — |
| −1 | K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) | Sophono, Inc. | 2011 | — |
| 0 (this device) | K132189 | Otomag Bone Conducation Hearing System | Sophono, Inc. | 2013 | — |
| +1 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016 | — |
| +2 | K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 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 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Summary page 1…one Conduction Regulatory Class: Class 11 Product Code: LXB Panel: Ear Nose and Throat Specialty Panel Predicate Device: Otornag Bone Conduction Hearing System - K102199 Device Description: The subject of this Traditional 510(k) is to obtain clearance forea modification in (he method of sterili… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | 2016 | 1 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K153391 (Sophono, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K102199.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Otnmgll A4pfr Sound Processor is intne for use with the Otomagmw Headbmwd or. Otomag 1 w Sofhnd (no ag hxmtatons), or with the OtomagTM Manetic Implan (patents; 5 yeass of age and up) for the foiowing patients and indicatons: * Patient vwh ccnihxtiwn or mixed heing Iossms uto can stil beneft froma amplificaio of swmod. The pure tone average (FrA) bone conduction (BC) threshold for the indicated ea should be better than 45 dB HL (measured at 0.51, 2…
Read the full statement (184 words)
The Otnmgll A4pfr Sound Processor is intne for use with the Otomagmw Headbmwd or. Otomag 1 w Sofhnd (no ag hxmtatons), or with the OtomagTM Manetic Implan (patents; 5 yeass of age and up) for the foiowing patients and indicatons:
* Patient vwh ccnihxtiwn or mixed heing Iossms uto can stil beneft froma amplificaio of swmod. The pure tone average (FrA) bone conduction (BC) threshold for the indicated ea should be better than 45 dB HL (measured at 0.51, 2, and 3 klz).
* Bilatetal fining is applicable for most patients baiing a symmrtwiclly wondudiwv or rmxed hearing loss. The diffierence between the left and rit sides- BC thresholds should be less than 10dB on average measured at 0.5, 1, 2, and 4 kHz. or less than 15 dB at individual
* Patients who have a profound seasonineinal hewing loss n ear and nan hewing in the oppomte ear, who fom some reason will not or tu u an AC CROS. The pne tmrs average (PTA) air cuiduction (AC) threshold of the hering ear should be bettes than 20 dB HL(measuredatO.5,. l2 and 3kHz).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132189: Otomag Bone Conducation Hearing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132189
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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