510(k) · Cleared
ClearedAN Evo 1, CS Evo 1, Contact Mini, Apollon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Audifon-USA, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Nov 1, 2012 as substantially equivalent to K935701 (Starkey Laboratories, Inc., 1994) after a 135-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Nov 1, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935701 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK935701 Viennatone an, Viennatone as Fidelity F228, Fidelity F229Starkey Laboratories, Inc. · 1994
- This deviceK121793 AN Evo 1, CS Evo 1, Contact Mini, ApollonAudifon-USA, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK172460 ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018
- Descendant · cites it directly · 0 of its ownK260452 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151…Zdeer Technology (Henan) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261256 Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018 · cites it directly1descendant
- K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd. · 2026 · cites it directly0descendants
- K261256Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)Shenzhen Magnet Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935701 | Viennatone an, Viennatone as Fidelity F228, Fidelity F229 | Starkey Laboratories, Inc. | 1994 | — |
| 0 (this device) | K121793 | AN Evo 1, CS Evo 1, Contact Mini, Apollon | Audifon-USA, Inc. | 2012 | — |
| +1 | K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| +1 | K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152… | Zdeer Technology (Henan) Co., Ltd. | 2026 | — |
| +1 | K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K935701 | Viennatone an, Viennatone as Fidelity F228, Fidelity F229Summary page 1…Grafenschachen 242 A-7423 Grafenschachen Austria Predicate Device K935701 Starkey Laboratories Inc. VIENNATONE AN, VIENNATONE AS FIDELITY F228,… | 1994 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K172460 (Med-El Elektromedizinische Geraete GmbH, 2018) has gone furthest, with 1 descendant 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. 2012, 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?
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.…
Read the full statement (126 words)
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
The target populations for the devices are as follows:
AN-Evol adults and children ( 12 years)
contact star evol adults and children ( 12 years)
contact mini adults and children (8 months)
apollon adults and children ( 12 years)
The apollon is a device where it is capable of utilizing either air or bone conduction.
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/K121793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121793
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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