FDA applicant

Ototech Intl., Inc.

Oklahoma City, OK1 decision1996–19960 recalls

FDA records 1 decision for Ototech Intl., Inc. (Oklahoma City, OK) in 1996: 1 510(k) clearance. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Ototech Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ototech Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ototech”

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

Ototech, Ltd. 5

Ototech Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ototech”