Cleared Traditional

K894019 - RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE

K894019 is an FDA 510(k) clearance for RESOUND DEMO. BEHIND-THE-EAR HRNG., manufactured by Resound Corp.. The device is a Class 2 Ear, Nose, Throat device with product code KHL cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K894019 · Resound Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K894019

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 90d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHL Device Classification - Class 2, Special Controls

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.