# K132189: Otomag Bone Conducation Hearing System

- Pathway: 510(k) (Traditional)
- Applicant: Sophono, Inc.
- Decided: Nov 22, 2013 after 130 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: 8 generations back to K861971 (1986). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M), Sophono, Inc. (2011) Summary page 1.

## Most influential descendants
- K153391: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (2016), 1 descendant of its own
- K243041: contact forte Alpha (2025), 0 descendants of its own

## Indications for use
The Otnmgll A4pfr Sound Processor is intne for use with the Otomagmw Headbmwd or. Otomag 1 w Sofhnd (no ag hxmtatons), or with the OtomagTM Manetic Implan (patents; 5 yeass of age and up) for the foiowing patients and indicatons: * Patient vwh ccnihxtiwn or mixed heing Iossms uto can stil beneft froma amplificaio of swmod. The pure tone average (FrA) bone conduction (BC) threshold for the indicated ea should be better than 45 dB HL (measured at 0.51, 2, and 3 klz). * Bilatetal fining is applicable for most patients baiing a symmrtwiclly wondudiwv or rmxed hearing loss. The diffierence between the left and rit sides- BC thresholds should be less than 10dB on average measured at 0.5, 1, 2, and 4 kHz. or less than 15 dB at individual * Patients who have a profound seasonineinal hewing loss n ear and nan hewing in the oppomte ear, who fom some reason will not or tu u an AC CROS. The pne tmrs average (PTA) air cuiduction (AC) threshold of the hering ear should be bettes than 20 dB HL(measuredatO.5,. l2 and 3kHz).

Source page: https://510kreport.com/device/K132189
Methodology: https://510kreport.com/methodology