FDA applicant

Crystal Tone Hearing Instruments

Des Moines, IA1 decision1986–19860 recalls

FDA records 1 decision for Crystal Tone Hearing Instruments (Des Moines, IA) in 1986: 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 Crystal Tone Hearing Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Crystal Tone Hearing Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Crystal”

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

Crystal Medical Products, Inc. 5 Crystal Diagnostics, Inc. 2 Crystal Medical Technology 2 Crystal Optical Co., Ltd. 1 Crystal Reflections, Int., Inc. 1 Crystal Care Intl., Inc. 1 Crystal Medtech, LLC 1 Crystal Mark, Inc. 1 Crystal-Seal Dental Implants 1

Crystal Tone Hearing Instruments

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Crystal”