# K153391: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

- Pathway: 510(k) (Traditional)
- Applicant: Sophono, Inc.
- Decided: Jun 16, 2016 after 205 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: 9 generations back to K861971 (1986). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132189: Otomag Bone Conducation Hearing System, Sophono, Inc. (2013) Summary page 4.
- K100360: BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment, Cochlear Americas (2010) Summary page 5.

## Most influential descendants
- K243041: contact forte Alpha (2025), 0 descendants of its own

## Indications for use
The Sophono® Sound Processor is intended for use with the Sophono® Headband (no age limitations), or with the Sophono® Magnetic Implant (patients 5 years of age and up) for the following patients and indications: Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz). Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies. Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

Source page: https://510kreport.com/device/K153391
Methodology: https://510kreport.com/methodology