# K171088: Cochlear Baha SoundArc

- Pathway: 510(k) (Special)
- Applicant: Cochlear Americas
- Decided: Jun 7, 2017 after 56 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: 9 generations back to K861971 (1986). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002913: Headband for Baha, Entific Medical Systems, Inc. (2000) Summary page 4.
- K080363: Baha Cordelle II, Cochlear Bone Anchored Systems AB (2008) Summary page 4.
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 4.
- K110996: Baha 3 Power Sound Processor, Cochlear Americas (2011) Summary page 4.
- K132278: Cochlear Baha  4 Sound Processor, Cochlear Americas (2013) Summary page 4.
- K142907: Baha 5 Sound Processor, Cochlear Americas (2015) Summary page 4.
- K153245: Baha 5 Super Power Sound Processor, Cochlear Americas (2016) Summary page 4.
- K161123: Baha 5 Power Sound Processor, Cochlear Americas (2016) Summary page 4.

## Indications for use
The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use: • Patients of any age 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 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors. • 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. • 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. • 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/K171088
Methodology: https://510kreport.com/methodology