Cleared Traditional

RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (K894019) - FDA 510(k) Clearance

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

K894019 · Resound Corp. · Ear, Nose, Throat device
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Sep 1989
Decision
107d
Days
Class 2
Risk

K894019 is an FDA 510(k) clearance for the RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE. Classified as Hearing Aid, Master (product code KHL), Class II - Special Controls.

Submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on September 21, 1989 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3330 - 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 Resound Corp. devices

Submission Details

510(k) Number K894019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1989
Decision Date September 21, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 89d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHL Hearing Aid, Master
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3330
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.