Cleared Traditional

K884044 - AUDIOMETER DIGITAL HEARING SYSTEM

K884044 is an FDA 510(k) clearance for AUDIOMETER DIGITAL HEARING SYSTEM, manufactured by Resound Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K884044 · Resound Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
149d
Days
Class 2
Risk

K884044 is an FDA 510(k) clearance for the AUDIOMETER DIGITAL HEARING SYSTEM. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on February 22, 1989 after a review of 149 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Resound Corp. devices

FDA 510(k) Submission Details - K884044

510(k) Number K884044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date February 22, 1989
Days to Decision 149 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 90d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K884044.
AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID
K890993 · Maico Hearing Instruments, Inc. · Oct 1989
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · Maico Hearing Instruments, Inc. · Jun 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · Welch Allyn, Inc. · Mar 1989
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
K883478 · Madsen Electronics (Canada) , Ltd. · Nov 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · American Electromedics Corp. · Jun 1988
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988