510(k) · Cleared
ClearedOtomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)
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 May 23, 2011 as substantially equivalent to K100193 (Sophono, Inc., 2010) and 2 other predicates after a 292-day review. Its family tree reaches back 7 generations to 1986. 4 later devices descend from it.
- Decided
- May 23, 2011
- Review
- 292 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K861971 (1986). 21 ancestors in all, the oldest K855059 (1986). 4 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 6 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 5 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 4 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 3 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 2 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 1 generation backK100193 Otomag Bone Conduction Hearing SystemSophono, Inc. · 2010
- This deviceK102199 Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1…Sophono, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK132189 Otomag Bone Conducation Hearing SystemSophono, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK153391 Sophono Bone Conduction Systems (S) Configuration and (M)…Sophono, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK243041 contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025
- Descendant · cites it directly · 0 of its ownK123962 Otomag Bone Conduction Hearing SystemSophono, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K132189Otomag Bone Conducation Hearing SystemSophono, Inc. · 2013 · cites it directly2descendants
- K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc. · 2016 · 2 generations on1descendant
- K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh · 2025 · 3 generations on0descendants
- K123962Otomag Bone Conduction Hearing SystemSophono, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −6 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −4 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −3 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −1 | K100193 | Otomag Bone Conduction Hearing System | Sophono, Inc. | 2010 | — |
| 0 (this device) | K102199 | Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) | Sophono, Inc. | 2011 | — |
| +1 | K132189 | Otomag Bone Conducation Hearing System | Sophono, Inc. | 2013 | — |
| +2 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016 | — |
| +3 | K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025 | — |
| +1 | K123962 | Otomag Bone Conduction Hearing System | Sophono, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K100193 | Otomag Bone Conduction Hearing SystemSummary page 1…n Panel: Ear, Nose and Throat *Regulation Number: 874.3300 *Product Code: LXB Predicate Device: Otomag Bone Conduction Hearing System, Unmodified Version - K1 001 93 Xomed Audiant Bone Conductor - K855059 / K861 971 Device Description: The Otomag Bone Conduction Hearing System is a family of so… | 2010 |
| * | K855059 | Audiant Bone Conductor or a.B.C.Summary page 1…ulation Number: 874.3300 *Product Code: LXB Predicate Device: Otomag Bone Conduction Hearing System, Unmodified Version - K1 001 93 Xomed Audiant Bone Conductor - K855059 / K861 971 Device Description: The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that ope… | 1986 |
| * | K861971 | Xomed Audiant Bone Conductor W/Improved AA CoilSummary page 1…mber: 874.3300 *Product Code: LXB Predicate Device: Otomag Bone Conduction Hearing System, Unmodified Version - K1 001 93 Xomed Audiant Bone Conductor - K855059 / K861 971 Device Description: The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the… | 1986 |
What descends from it? (4)
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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K132189 (Sophono, Inc., 2013) has gone furthest, with 2 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. 2011, 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 Otomag Alpha I Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations), or with the Otomag Osseointegrated Magnetic Implant (patients 5 years of age and up) for the following patients and indications: Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45…
Read the full statement (190 words)
The Otomag Alpha I Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations), or with the Otomag Osseointegrated Magnetic Implant (patients 5 years of age and up) for the following patients and indications:
Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies.
Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102199
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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