510(k) Report

FDA applicant

Audioscience, Inc.

Minnetonka, MN4 decisions1990–19940 recalls

FDA records 4 decisions for Audioscience, Inc. (Minnetonka, MN) from 1990 to 1994: 4 510(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 Audioscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Audioscience, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Audioscience, 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, Prescription4decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K902846Prizm Hearing SystemAudioscience, Inc. · 19901cites it

What has FDA decided for it lately?

  • K936007Prizm Hearing System, Model Power BteAudioscience, Inc. · 1994
  • K930909Prizm Hearing SystemAudioscience, Inc. · 1993
  • K922422Programmable Hearing System, Ite and Bte TypesAudioscience, Inc. · 1992
  • K902846Prizm Hearing SystemAudioscience, Inc. · 1990

All 4 as Audioscience, Inc. →