FDA applicant

Finetone Hearing Instruments

Scarborough, ME5 decisions1983–19980 recalls

FDA records 5 decisions for Finetone Hearing Instruments (Scarborough, ME) from 1983 to 1998: 5 510(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 Finetone Hearing Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Finetone Hearing Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Finetone Hearing Instruments

Which product codes does it file in?

What has FDA decided for it lately?