510(k) · Cleared
ClearedBranemark Bone-Anchored Hearing Aid (Baha) Cordelle II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entific Medical Systems, Inc. · LXB Hearing Aid, Bone Conduction
Cleared on Nov 24, 1999 as substantially equivalent to K955713 (Nobelpharma USA, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1986. 36 later devices descend from it.
- Decided
- Nov 24, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K861971 (1986). 5 ancestors in all. 36 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 2 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 1 generation backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- This deviceK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- Descendant · cites it directly · 35 of its ownK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- Descendant · 2 generations on · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 3 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · 3 generations on · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 4 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K080363Baha Cordelle IICochlear Bone Anchored Systems AB · 2008 · cites it directly35descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · 2 generations on33descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 3 generations on11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · 3 generations on11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −2 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −1 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| 0 (this device) | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| +1 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| +2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +3 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +3 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +4 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K955713 | Nobelpharma Bone Anchored Hearing AidSummary page 1…atients 5 years old or older. C. The Predicate Product The predicate praducts used in this Premarket Notification are the Branemark Bone- Anchored Hearing Aid (BAHA™), K955713 and K984162, the Branemark System® Bone Anchored Craniofacial Prosthetic Attachment System, K945154 and other bone conduction hea… | 1996 |
| * | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseSummary page 1…ars old or older. C. The Predicate Product The predicate praducts used in this Premarket Notification are the Branemark Bone- Anchored Hearing Aid (BAHA™), K955713 and K984162, the Branemark System® Bone Anchored Craniofacial Prosthetic Attachment System, K945154 and other bone conduction hearing aids.… | 1999 |
| * | K945154 | BA-CpasSummary page 1…et Notification are the Branemark Bone- Anchored Hearing Aid (BAHA™), K955713 and K984162, the Branemark System® Bone Anchored Craniofacial Prosthetic Attachment System, K945154 and other bone conduction hearing aids. D. Description of the Device The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle I… | 1995 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080363 | Baha Cordelle II | 2008 | 35 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K080363 (Cochlear Bone Anchored Systems AB, 2008) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K955713.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This device is to be used by patients who have a conductive hearing loss and can still- benefit fiom sound amplification. Als indicated are paticuts with wixed heuing loss with average bone conduction thresholds in the indicated ear better than 45dB HL. The nominal output from the BAHA Cordelle Il is on average 13 dB stronger than the Classic 300 mode! (measured at 0,5,1,2,3 kHz). The Corddle is reconunended for patients having the same indications for…
Read the full statement (327 words)
This device is to be used by patients who have a conductive hearing loss and can still-
benefit fiom sound amplification. Als indicated are paticuts with wixed heuing loss with
average bone conduction thresholds in the indicated ear better than 45dB HL. The
nominal output from the BAHA Cordelle Il is on average 13 dB stronger than the Classic
300 mode! (measured at 0,5,1,2,3 kHz). The Corddle is reconunended for patients having
the same indications for the Classic 300 but where slightly stronger amplification is needed
than what is delivered by the Classic 300 model. (Patients with bone conduction
thresholds better than 45dB HL will be expectied 1o improve, but may not achieve levels in
the normal range, Patients with a bone conduction threshaold where each standard
measured frequency threshold is less than 25 dB HL can be cxpected to have restored
hearing levels in the normal range.) The patients indicated for this device must also be
unable to use conventional air conduction hearing aids or undergo ossicular replacement
surgery because of one of the following:
1. Chronic otitis media (COM); or
2. Congenital malformation (CM) of the middle/external ear; or
3. Otber acquired malfunctions of the middle or external ear ¢anals which preclude the
wearing of a conventional air conduction hearing aid.
Additional indications to be met by perspective BAHA™Cordelle I candidates:
1. Patients (either by themselves or with the aid of others) must be able to maintain the
abutment/skin interface of the BAHA Therefore, careful consideration must be given
as to the patient’s psychological, physical, emotional and developmental capabilities
to maintain hygiene. In the case of children part, but not all, of that responsibility falls
on the parents or guardian.
2. For children and patients with coogenital malformations, sufficieat boae valume and
bone quality must be present for a successful fixture implantation. Alternative treat-
ment such as conventional bone conduction hearing aids, should be considered for
patients having a discase state that might jeopardize asseointegration.
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/K992872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992872: Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992872
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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