510(k) · Cleared
ClearedADHEAR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-El Elektromedizinische Geraete GmbH · LXB Hearing Aid, Bone Conduction
Cleared on Apr 27, 2018 as substantially equivalent to K121793 (Audifon-USA, Inc., 2012) and 1 other predicate after a 256-day review. Its family tree reaches back 8 generations to 1986. 1 later device descends from it.
- Decided
- Apr 27, 2018
- Review
- 256 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K861971 (1986). 21 ancestors in all. 1 later device descends 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 backK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- 1 generation backK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
- This deviceK172460 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
Most influential descendants
Showing 1 of 1 · See all- K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd. · 2026 · cites it directly0descendants
View 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 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| −1 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
| 0 (this device) | 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 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K121793 | AN Evo 1, CS Evo 1, Contact Mini, ApollonSummary page 4…fication: 21 CFR§874.3300, Hearing Aid Product Code: LXB, Hearing Aid, Bone Conduction III. PREDICATE DEVICES Contact Mini, audifon USA Inc. (K121793) Primary Predicate BAHA 5, Cochlear Americas (K142907) Secondary Predicate No reference devices were used in this… | 2012 |
| * | K142907 | Baha 5 Sound ProcessorSummary page 4…ode: LXB, Hearing Aid, Bone Conduction III. PREDICATE DEVICES Contact Mini, audifon USA Inc. (K121793) Primary Predicate BAHA 5, Cochlear Americas (K142907) Secondary Predicate No reference devices were used in this submission. IV. DEVICE DESCRIPTION… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153… | 2026 | 0 |
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 32 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K260452 (Zdeer Technology (Henan) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121793.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient’s head with an elastic headband or an adhesive adapter that is placed behind the auricle. Indications: • Unilateral or bilateral conductive hearing loss, either chronic or temporary. The pure tone average bone-conduction…
Read the full statement (133 words)
The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient’s head with an elastic headband or an adhesive adapter that is placed behind the auricle.
Indications:
• 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 as stated in the FDA summary.
https://510kreport.com/device/K172460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172460: ADHEAR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172460
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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