# K153245: Baha 5 Super Power Sound Processor

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Mar 2, 2016 after 114 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: 8 generations back to K861971 (1986). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150751: Cordelle II Sound Processor, Cochlear Americas (2015) Summary page 4.
- K142907: Baha 5 Sound Processor, Cochlear Americas (2015) Summary page 5.

## Most influential descendants
- K171088: Cochlear Baha SoundArc (2017), 0 descendants of its own

## Indications for use
The CochlearTM Baha® 5 SuperPower Sound Processor 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 65 dB HL for use with the Baha 5 SuperPower 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-conduction thresholds are defined as less than a 10 dB average difference between ears (measure 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 was with normal hearing in the other ear (i.e. Single-sided deadness: SSDTM ). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measure 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/K153245
Methodology: https://510kreport.com/methodology