FDA applicant

Sound Crafters Hearing Instruments

Mission, KS1 decision1987–19870 recalls

FDA records 1 decision for Sound Crafters Hearing Instruments (Mission, KS) in 1987: 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 Sound Crafters Hearing Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sound Crafters Hearing Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sound Crafters 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 “Sound”

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

Sound Surgical Technologies, LLC 6 Sound Health Systems, Inc. 2 Sound 2000 Medical Systems, Inc. 1 Sound Options Tinnitus Treatments, Inc. 1 Sound Imaging, Inc. 1 Sound Life Sciences, Inc. 1 Sound Land Corp. 1 Sound Acoustic Systems, Ltd. 1 Sound Technique System, LLC 1 Sound Hearing Instruments, Inc. 1 Sound Linked Data, Inc. 1

Sound Crafters Hearing Instruments

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sound”