# K131240: Cochlear Baha Implant System, Cochlear Baha Attract

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Nov 7, 2013 after 190 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K150751: Cordelle II Sound Processor (2015), 2 descendants of its own
- K153245: Baha 5 Super Power Sound Processor (2016), 1 descendant of its own
- K171088: Cochlear Baha SoundArc (2017), 0 descendants of its own

## Recalls of this device
- Apr 9, 2014 · Class II · Z-1699-2014: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K131240
Methodology: https://510kreport.com/methodology