510(k) · Cleared
ClearedBone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zdeer Technology (Henan) Co., Ltd. · LXB Hearing Aid, Bone Conduction
Cleared on Jun 15, 2026 as substantially equivalent to K172460 (Med-El Elektromedizinische Geraete GmbH, 2018) and 1 other predicate after a 124-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Jun 15, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K861971 (1986). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 5 generations between
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK172460 ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018
- This deviceK260452 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151…Zdeer Technology (Henan) Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 8 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 7 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 6 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 5 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 4 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 3 generations backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 2 generations backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- 1 generation backK172460 ADHEAR SystemMed-El Elektromedizinische Geraete GmbH · 2018
- This deviceK260452 Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151…Zdeer Technology (Henan) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −8 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −6 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −5 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −4 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −3 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −2 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| −1 | K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| 0 (this device) | K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152… | Zdeer Technology (Henan) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K172460 | ADHEAR SystemSummary page 5…r 874.3302 Product Code(s) LXB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172460 Adhere system LXB K121793 bone conduction hearing aid LXB Device Description Summary 21 CFR 807.92(a)(4) This Bone Conduction He… | 2018 |
| * | K121793 | AN Evo 1, CS Evo 1, Contact Mini, ApollonSummary page 5…LXB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172460 Adhere system LXB K121793 bone conduction hearing aid LXB Device Description Summary 21 CFR 807.92(a)(4) This Bone Conduction Hearing Aid is a head-worn d… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 device is a wearable, non-invasive, and non-implanted bone conduction hearing aid intended to treat patients of patients aged 12 years and older with conductive hearing loss or single-sided deafness. It utilizes an ear-hook design to ensure stable mechanical coupling between the transducer and the temporal bone. * Unilateral or bilateral conductive hearing loss, either chronic or temporary. The pure tone average bone-conduction hearing threshold…
Read the full statement (127 words)
The device is a wearable, non-invasive, and non-implanted bone conduction hearing aid intended to treat patients of patients aged 12 years and older with conductive hearing loss or single-sided deafness. It utilizes an ear-hook design to ensure stable mechanical coupling between the transducer and the temporal bone.
* Unilateral or bilateral conductive hearing loss, either chronic or temporary.
The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 25 dB HL.
* Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
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/K260452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260452: Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260452
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026