# K254296: Ossiclear (Ossiclear System)

- Pathway: 510(k) (Traditional)
- Applicant: Sounduct
- Decided: Jul 22, 2026 after 203 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: 11 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)
- K212136: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App, Cochlear Americas (2021) Summary page 5.

## Indications for use
Ossiclear System is indicated for the following patients aged 12 years 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 55 dB HL. • Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally moderate to profound conductive or mixed hearing loss. Symmetrical bone conduction thresholds are defined as less than a 10 dB HL average difference between ears (measured at 0.5 1 2 and 3 kHz), or less than a 15 dB HL 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. • Any patient who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid.

Source page: https://510kreport.com/device/K254296
Methodology: https://510kreport.com/methodology