510(k) · Cleared
ClearedCordelle II Sound Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · LXB Hearing Aid, Bone Conduction
Cleared on Jul 22, 2015 as substantially equivalent to K080363 (Cochlear Bone Anchored Systems AB, 2008) and 1 other predicate after a 121-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Jul 22, 2015
- Review
- 121 days
- Class
- Class II
- Product code
- LXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861971 (1986). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 4 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 3 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 2 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 1 generation backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- This deviceK150751 Cordelle II Sound ProcessorCochlear Americas · 2015
- Descendant · cites it directly · 1 of its ownK153245 Baha 5 Super Power Sound ProcessorCochlear Americas · 2016
- Descendant · 2 generations on · 0 of its ownK171088 Cochlear Baha SoundArcCochlear Americas · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −4 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −2 | 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 | — |
| 0 (this device) | K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015 | — |
| +1 | K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016 | — |
| +2 | K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K080363 | Baha Cordelle IISummary page 4…21 CFR 874.3300, Class II Classification Panel Ear, Nose, and Throat Product Code: LXB 510(k): K080363 Trade/Proprietary Name: CochlearTM Baha® Attract Common/Usual Name: Auditory Osseointegrated Implant… | 2008 |
| * | K131240 | Cochlear Baha Implant System, Cochlear Baha AttractSummary page 5…74.3300, Class II Classification Panel Ear, Nose, and Throat Product Code: LXB 510(k): K131240 F. Purpose of Submission The purpose of this Traditional 510(k) is to expand the fitting indications of the Baha Attract System… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153245 | Baha 5 Super Power Sound Processor | 2016 | 1 |
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 29 years and passes through 5 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K153245 (Cochlear Americas, 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K080363.
How does its category compare?
All LXB devicesLXB Hearing Aid, Bone Conduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement. The Cochlear Baha® Attract is intended for the following patients and indications for use: x Patients aged 5 and older x Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz)…
Read the full statement (266 words)
Conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement.
The Cochlear Baha® Attract is intended for the following patients and indications for use:
x Patients aged 5 and older
x Patients who have a conductive or mixed hearing loss and can still benefit from sound
amplification. The pure tone average bone-conduction hearing threshold (measured at
0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100,
Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 sound processor,
and better than or equal to 65 dB HL for use with the Cordelle II sound processor.
x Bilateral fitting is intended for patients who meet the above criterion in both ears, with
bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical
bone-conductive thresholds are defined as less than a 10 dB average difference between
ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual
frequencies.
x Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing
in the other ear (i.e. Single-sided deafness: SSDTM). 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.
x Baha for SSD is also indicated for any patient who is indicated for an air conduction
contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot
or will not use an AC CROS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150751 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150751: Cordelle II Sound Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150751
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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