# K182116: BA310 Abutment, BIA310 Implant/Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Dec 19, 2018 after 135 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: 9 generations back to K861971 (1986). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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 4.
- K121317: Cochlear Baha Implant System, Cochlear Americas (2012) Summary page 4.
- K161671: Ponto 3, Ponto 3 Power and Ponto 3 SuperPower, Oticon Medical AB (2016) Summary page 4.

## Indications for use
The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) 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 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the 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: 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. Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.

Source page: https://510kreport.com/device/K182116
Methodology: https://510kreport.com/methodology