# K123962: Otomag Bone Conduction Hearing System

- Pathway: 510(k) (Traditional)
- Applicant: Sophono, Inc.
- Decided: Apr 8, 2013 after 103 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.
No later device cites it as a predicate yet.
0 of 23 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.

## Indications for use
The Otomag Alpha Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations), or with the Otomag 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 dB3 I-HL (measured at 0.5, 1, 2, and 3 k~z). * 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 I10dB 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 CR05. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB3 HL (measured at 0.5, 1, 2 and 3 kI-z).

Source page: https://510kreport.com/device/K123962
Methodology: https://510kreport.com/methodology