# K132278: Cochlear Baha  4 Sound Processor

- Pathway: 510(k) (Special)
- Applicant: Cochlear Americas
- Decided: Sep 26, 2013 after 65 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: 6 generations back to K861971 (1986). 17 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 2.

## Most influential descendants
- K142907: Baha 5 Sound Processor (2015), 10 descendants of its own
- K161123: Baha 5 Power Sound Processor (2016), 6 descendants of its own
- K202048: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (2021), 3 descendants of its own
- K212136: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (2021), 1 descendant of its own
- K172460: ADHEAR System (2018), 1 descendant of its own

## Indications for use
The Cochlear Baha® 4 sound processor has the following indications for use: * Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system. * 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 3 kHz) should be better than or equal to 45 dB HL. * Bilateral fitting is intended for patients who meet the criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction 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 15 dB 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). 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. * 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/K132278
Methodology: https://510kreport.com/methodology