Cleared Traditional

K023859 - SMARTTROAE

K023859 is an FDA 510(k) clearance for SMARTTROAE, 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 49-day FDA review.

K023859 · Intelligent Hearing Systems · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
49d
Days
Class 2
Risk

K023859 is an FDA 510(k) clearance for the SMARTTROAE. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on January 8, 2003 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intelligent Hearing Systems devices

FDA 510(k) Submission Details - K023859

510(k) Number K023859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date January 08, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 90d · This submission: 49d
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 103
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K023859.
COCHLEA-SCAN / COCHLEA-SCAN PLUS
K061744 · Bio-Logic Systems Corp. · Sep 2006
PILOT TEST OR DETECTIVE AUDIOMETERS
K060883 · Interacoustics A/S · Jun 2006
BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp. · Jun 2002
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547 · Resound Corp. · Mar 1999
AMPLAID A315 AND A319
K983915 · Amplifon S.P.A. · Jan 1999