510(k) Report

FDA applicant

Ear Technology Corp.

Johnson City, TN2 decisions1997–20060 recalls

FDA records 2 decisions for Ear Technology Corp. (Johnson City, TN) from 1997 to 2006: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and LXB (Hearing Aid, Bone Conduction). 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 Ear Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ear Technology Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ear Technology Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report