# K142907: Baha 5 Sound Processor

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Mar 25, 2015 after 170 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
Longest line of descent: 7 generations back to K861971 (1986). 18 ancestors in all.
10 later devices descend from it; 4 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)
- K132278: Cochlear Baha  4 Sound Processor, Cochlear Americas (2013) Summary page 5.

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

## Recalls of this device
- Dec 18, 2018 · Class II · Z-0792-2020: Product was packaged with the Incorrect tamper proof battery door.

## Indications for use
The Cochlear Baha 5 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/K142907
Methodology: https://510kreport.com/methodology