# K250215: Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear
- Decided: May 29, 2025 after 125 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: 10 generations back to K861971 (1986). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202048: Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App, Cochlear Americas (2021) Summary page 6.
- K002913: Headband for Baha, Entific Medical Systems, Inc. (2000) Summary page 7.

## Indications for use
The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use: Patient of any age for use with the Baha SoundBand, Baha Softband (or headband) or Baha SoundArc. 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 3kHz) should be better than or equal to 55 dB HL. 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 (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 deadness: 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/K250215
Methodology: https://510kreport.com/methodology