Cleared Traditional

K061744 - COCHLEA-SCAN / COCHLEA-SCAN PLUS

K061744 is an FDA 510(k) clearance for COCHLEA-SCAN / COCHLEA-SCAN PLUS, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K061744 · Bio-Logic Systems Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
86d
Days
Class 2
Risk

K061744 is an FDA 510(k) clearance for the COCHLEA-SCAN / COCHLEA-SCAN PLUS. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 86 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 Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K061744

510(k) Number K061744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date September 15, 2006
Days to Decision 86 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
3d faster than avg
Panel avg: 89d · This submission: 86d
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 56
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K061744.
Sera
K173567 · Interacoustics A/S · Feb 2018
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K122496 · Bio-Logic Systems Corp. · Nov 2012
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512 · Bio-Logic Systems Corp. · Jul 2012
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