# K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Jul 13, 2010 after 151 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K153391: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (2016), 1 descendant of its own
- K121317: Cochlear Baha Implant System (2012), 1 descendant of its own
- K243041: contact forte Alpha (2025), 0 descendants of its own
- K182116: BA310 Abutment, BIA310 Implant/Abutment (2018), 0 descendants of its own

## Indications for use
The Cochlear Baha®f auditory osseointegrated implant system using model B1300 implant and model BA300 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 3 kHz) should be better than or equal to 45 dB HL for use with the BPI 00 sound processor, 55 dB HL for use with the Intenso sound processor, and 65 dB HL for use with the Cordelle LI 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 (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 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 CR05.

Source page: https://510kreport.com/device/K100360
Methodology: https://510kreport.com/methodology