FDA applicant

Audina Hearing Instrument

Longwood, FL8 decisions1982–19970 recalls

FDA records 8 decisions for Audina Hearing Instrument (Longwood, FL) from 1982 to 1997: 8 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and LRB (Face Plate Hearing Aid). 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, ear, nose and throat panel, where it files most

How often FDA has decided Audina Hearing Instrument’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Audina Hearing Instrument since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Audina Hearing Instrument

Which product codes does it file in?

What has FDA decided for it lately?