# Infant Hearing Assessment Foundation

- Location (FDA's records): Mchenry, IL
- FDA decisions: 1 (1981–1981): 1 510(k) clearance
- Product codes: GWJ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K810138: Synap-I Infant Sensory Assessment Unit (Apr 3, 1981)

Source page: https://510kreport.com/company/infant-hearing-assessment-foundation