FDA applicant

Infant Hearing Assessment Foundation

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Infant Hearing Assessment Foundation (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code GWJ (Stimulator, Auditory, Evoked Response). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Infant Hearing Assessment Foundation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infant Hearing Assessment Foundation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Infant Hearing Assessment Foundation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Infant”

FDA records each applicant name separately; these may or may not be the same firm.

Infant Advantage, Inc. 5

Infant Hearing Assessment Foundation

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Infant”