# K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)

- Pathway: 510(k) (Traditional)
- Applicant: Sophono, Inc.
- Decided: May 23, 2011 after 292 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: 7 generations back to K861971 (1986). 21 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K100193: Otomag Bone Conduction Hearing System, Sophono, Inc. (2010) Summary page 1.
- K855059: Audiant Bone Conductor or a.B.C., Xomed, Inc. (1986) Summary page 1.
- K861971: Xomed Audiant Bone Conductor W/Improved AA Coil, Xomed, Inc. (1986) Summary page 1.

## Most influential descendants
- 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 I Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations), or with the Otomag Osseointegrated 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/K102199
Methodology: https://510kreport.com/methodology