# K100193: Otomag Bone Conduction Hearing System

- Pathway: 510(k) (Traditional)
- Applicant: Sophono, Inc.
- Decided: May 18, 2010 after 116 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: 6 generations back to K861971 (1986). 19 ancestors in all.
5 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)
- K090996: Ponto Pro, Oticon Medical AB (2009) Summary page 1.
- K090720: Cochlear Baha BP100, Cochlear Bone Anchored Systems AB (2009) Summary page 1.

## Most influential descendants
- K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) (2011), 4 descendants of its own
- K132189: Otomag Bone Conducation Hearing System (2013), 2 descendants of its own
- 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
- K123962: Otomag Bone Conduction Hearing System (2013), 0 descendants of its own

## Indications for use
The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otonmag Softband (no age limitations) 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 H4L (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 10dB 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 dB HL (measured at 0.5, 1, 2 and 3 ld-z). The Otomag Alpha 1 (5) Sound Processor is intended to be connected to the Otornag Headband or Softband.

Source page: https://510kreport.com/device/K100193
Methodology: https://510kreport.com/methodology