Cleared Traditional

K980533 - ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)

K980533 is an FDA 510(k) clearance for ERO-SCAN OTOACOUSTIC EMISSIONS TEST INS..., manufactured by Etymotic Research. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K980533 · Etymotic Research · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
40d
Days
Class 2
Risk

K980533 is an FDA 510(k) clearance for the ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34). Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Etymotic Research (Danville, US). The FDA issued a Cleared decision on March 23, 1998 after a review of 40 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 Etymotic Research devices

FDA 510(k) Submission Details - K980533

510(k) Number K980533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date March 23, 1998
Days to Decision 40 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 90d · This submission: 40d
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 130
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K980533.
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K981327 · Idem (Int'L Dist. of Electronics For Medicine) · May 1998
MAICO MA53
K981142 · Bernafon-Maico, Inc. · Apr 1998
HORTMANN AMDIS-OAE OAE ANALYZER
K980505 · Hortmann AG · Apr 1998
SIBELMED AC50D
K973377 · Trutone · Mar 1998
GSI 70 AUDIOPATH SCREENER
K974237 · Grason-Stadler, Inc. · Feb 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · Bio-Logic Systems Corp. · Jan 1998