Cleared Traditional

K892338 - BEHIND-THE-EAR HEARING AID MODEL 48 AGCI

K892338 is the FDA 510(k) clearance for BEHIND-THE-EAR HEARING AID MODEL 48 AGCI by Qualitone. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K892338 · Qualitone · Ear, Nose, Throat device
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Aug 1989
Decision
120d
Days
Class 1
Risk

K892338 is an FDA 510(k) clearance for the BEHIND-THE-EAR HEARING AID MODEL 48 AGCI. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Qualitone (Minneapolis, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 Qualitone devices

Submission Details

510(k) Number K892338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date August 03, 1989
Days to Decision 120 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
31d slower than avg
Panel avg: 89d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K892338.
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · Oticon Corp. · Aug 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · Electone, Inc. · Aug 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · Resound Corp. · Aug 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · Electone, Inc. · Jun 1989
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
K892336 · Qualitone · May 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337 · Qualitone · May 1989