510(k) Report

FDA applicant

Personal Sound Technologies, Inc.

Rochester, NY2 decisions1992–19930 recalls

FDA records 2 decisions for Personal Sound Technologies, Inc. (Rochester, NY) from 1992 to 1993: 2 510(k) clearances. 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 Personal Sound Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Personal Sound Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription2decisions

What has FDA decided for it lately?

  • K930541Voicemode, Ite, Air-Conduction Hearing AidPersonal Sound Technologies, Inc. · 1993
  • K923924VoicewavePersonal Sound Technologies, Inc. · 1992

All 2 as Personal Sound Technologies, Inc. →

Other applicant names beginning “Personal”

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

Personal Products Co. 45Personal Genome Diagnostics, Inc. 3Personal Products Co., Div. of Mcneil Ppc, Inc. 2Personal Products Company, Div. of Mcneil-Ppc, Inc. 2Personal Health & Hygiene, Inc. 1Personal Emergency Response System 1Personal Professional Products, Inc. 1Personal Computers For Medicine, Inc. 1Personal Health Institute International 1