510(k) · Cleared
Recalled · Class II · 2014Cochlear Baha Implant System, Cochlear Baha Attract
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 Nov 7, 2013 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2013
- Review
- 190 days
- Class
- Class II
- Product code
- LXB
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK131240 Cochlear Baha Implant System, Cochlear Baha AttractCochlear Americas · 2013
- Descendant · cites it directly · 2 of its ownK150751 Cordelle II Sound ProcessorCochlear Americas · 2015
- Descendant · 2 generations on · 1 of its ownK153245 Baha 5 Super Power Sound ProcessorCochlear Americas · 2016
- Descendant · 3 generations on · 0 of its ownK171088 Cochlear Baha SoundArcCochlear Americas · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131240 | Cochlear Baha Implant System, Cochlear Baha Attract | Cochlear Americas | 2013 | — |
| +1 | K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015 | — |
| +2 | K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016 | — |
| +3 | K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150751 | Cordelle II Sound Processor | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2014 | Class II | Z-1699-2014 | Process control | Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K150751 (Cochlear Americas, 2015) has gone furthest, with 2 descendants 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. 2013, 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 Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet. The Baha Attract Is indicated for conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement. The Cochlear BahaV Attract is intended for the…
Read the full statement (284 words)
The Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet. The Baha Attract Is indicated for conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement.
The Cochlear BahaV Attract is intended for the following patients and indications for use:
* Patients aged 5 and older
* 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 dB3 HL for use with the BP1 00 sound processor, and 55 dB HL for use with the BP1IO0 sound processor.
* 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 dB3 average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15dB difference at individual frequencies.
* Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD"m). 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 20d13 HL.
* Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CR08) hearing aid, but who for some reason cannot or will not use an AC CR08.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131240: Cochlear Baha Implant System, Cochlear Baha Attract.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131240
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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