Cleared Traditional

K791170 - MIS AURAL ACOUSTIC SCREENER

K791170 is an FDA 510(k) clearance for MIS AURAL ACOUSTIC SCREENER, manufactured by Maico Hearing Instruments, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway .

K791170 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat device
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Jun 1979
Decision
-
Days
Class 2
Risk

K791170 is an FDA 510(k) clearance for the MIS AURAL ACOUSTIC SCREENER. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Maico Hearing Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1979.

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 Maico Hearing Instruments, Inc. devices

FDA 510(k) Submission Details - K791170

510(k) Number K791170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received June 25, 1979
Decision Date June 25, 1979
Days to Decision -
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
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 K791170.
PORTABLE AUDIOMETERS
K811727 · Maico Hearing Instruments, Inc. · Jul 1981
TINNITUS RESEARCH AUDIOMETER
K802560 · Starkey Laboratories, Inc. · Nov 1980
RION DIAGNOSTIC AUDIOMETER
K802207 · Rion Acoustic Instruments, Inc. · Sep 1980
PREAMPLIFIER MODELS 8101PI & 8102PI
K781474 · Life-Tech Instruments, Inc. · Sep 1978
AUDIOMETER, PORTABLE, AIR CONDUCTION
K780382 · Maico Hearing Instruments, Inc. · Mar 1978
COMPUTER AUDIOMETER - MA25
K780269 · Maico Hearing Instruments, Inc. · Feb 1978