Cleared Traditional

MIS AURAL ACOUSTIC SCREENER (K791170) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.