# K260902: Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System

- Pathway: 510(k) (Traditional)
- Applicant: Cochlear Americas
- Decided: Jul 10, 2026 after 114 days
- Product code: PFO (Active Implantable Bone Conduction Hearing System)
- Device class: 2
- Regulation: 21 CFR 874.3340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN170009 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240155: Cochlear Osia System, Cochlear Americas (2024) Summary page 6.
- (no number) Osia Fitting Software 2: named in the summary without a submission number
- (no number) previous version of the Osia Smart App: named in the summary without a submission number

## Indications for use
The Osia System is intended for the following patients and indications: * Patients 5 years of age or older. « Patients who have a conductive or mixed hearing loss (up to 65 dB HL sensorineural hearing loss) and still can benefit from sound amplification. Patients with mixed hearing loss should be evaluated according to the fitting range of the sound processor in combination with the implant used. » Bilateral fitting of the Osia System is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides’ BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies. « Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or “SSD”). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz). » The Osia System 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. * Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

Source page: https://510kreport.com/device/K260902
Methodology: https://510kreport.com/methodology