# K121317: Cochlear Baha Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Oct 12, 2012 after 163 days
- Product code: MAH (Hearing Aid, Bone Conduction, Implanted)
- 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: 1 generation back to K100360 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment, Cochlear Americas (2010) Summary page 1.

## Most influential descendants
- K182116: BA310 Abutment, BIA310 Implant/Abutment (2018), 0 descendants of its own

## Indications for use
The Cochlear Baha@ auditory osseointegrated implant system using model BA400 abutment 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 45 dB3 HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55dcb HL for use with the BPI1O Power sound processor, and 65 db HL for use with the Cordelle 11Sound 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-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 norm al 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 SSID is also indicated for any patient whd 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 GROS.

Source page: https://510kreport.com/device/K121317
Methodology: https://510kreport.com/methodology