Cleared Traditional

K964426 - SMARTOAE

K964426 is an FDA 510(k) clearance for SMARTOAE, manufactured by Intelligent Hearing Systems. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964426 · Intelligent Hearing Systems · Ear, Nose, Throat device
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Feb 1997
Decision
90d
Days
Class 2
Risk

K964426 is an FDA 510(k) clearance for the SMARTOAE. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on February 3, 1997 after a review of 90 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 Intelligent Hearing Systems devices

FDA 510(k) Submission Details - K964426

510(k) Number K964426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date February 03, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 90d · This submission: 90d
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 102
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K964426.
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132 · Bio-Logic Systems Corp. · May 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
K970279 · American Electromedics Corp. · Mar 1997
IL0292 DP ECHOPORT
K970555 · Smith · Mar 1997
PORTAREM-3000, PFS-6000
K964340 · Starkey Laboratories, Inc. · Jan 1997
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT
K961447 · Bio-Logic Systems Corp. · May 1996
GSI 61 CLINICAL AUDIOMETER
K953684 · Grason-Stadler, Inc. · Oct 1995