# K150751: Cordelle II Sound Processor

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Jul 22, 2015 after 121 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861971 (1986). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080363: Baha Cordelle II, Cochlear Bone Anchored Systems AB (2008) Summary page 4.
- K131240: Cochlear Baha Implant System, Cochlear Baha Attract, Cochlear Americas (2013) Summary page 5.

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

## Indications for use
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.

Source page: https://510kreport.com/device/K150751
Methodology: https://510kreport.com/methodology