Cleared Traditional

K904622 - HEARING CHECKER(TM)

K904622 is the FDA 510(k) clearance for HEARING CHECKER(TM) by Qualitone Hearing Aids and Audiometers. It is a Class 2 Ear, Nose, Throat device (product code EWO) cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K904622 · Qualitone Hearing Aids and Audiometers · Ear, Nose, Throat device
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Sep 1991
Decision
341d
Days
Class 2
Risk

K904622 is an FDA 510(k) clearance for the HEARING CHECKER(TM), DESKTOP MODEL. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Qualitone Hearing Aids and Audiometers (Minneapolis, US). The FDA issued a Cleared decision on September 17, 1991 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Qualitone Hearing Aids and Audiometers devices

Submission Details

510(k) Number K904622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date September 17, 1991
Days to Decision 341 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 89d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K904622.
DANPLEX SCREENING AUDIOMETER
K923074 · Life-Tech Intl., Inc. · Sep 1992
ACOUSTIC APPRAISE CD-3
K923013 · Qualitone · Aug 1992
THE BELTONE AUDIO SCOUT
K915323 · Beltone Electronics Corp. · May 1992
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · Resound Corp. · Sep 1991
MAICO MA800 AUDIOMETER
K911368 · Maico Hearing Instruments, Inc. · Jun 1991
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID
K904544 · Qualitone · Oct 1990