# Sophono, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 5 (2010–2016): 5 510(k) clearances
- Product codes: LXB (5)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xomed, Inc.: 2 (https://510kreport.com/company/xomed)
- Oticon Medical AB: 1 (https://510kreport.com/company/oticon-medical)
- Cochlear Bone Anchored Systems AB: 1 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Cochlear Americas: 1 (https://510kreport.com/company/cochlear-americas)

## Firms that cite its devices most
- Bhm-Tech Produktionsgesellschaft Mbh: 1 (https://510kreport.com/company/bhm-tech-produktionsgesellschaft-mbh)

## Its most-cited devices
- K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) (2011), cited by 2
- K100193: Otomag Bone Conduction Hearing System (2010), cited by 1
- K132189: Otomag Bone Conducation Hearing System (2013), cited by 1
- K153391: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (2016), cited by 1

## Recent decisions
- K153391: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (Jun 16, 2016)
- K132189: Otomag Bone Conducation Hearing System (Nov 22, 2013)
- K123962: Otomag Bone Conduction Hearing System (Apr 8, 2013)
- K102199: Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M) (May 23, 2011)
- K100193: Otomag Bone Conduction Hearing System (May 18, 2010)

Source page: https://510kreport.com/company/sophono