Cleared Traditional

K892336 - BEHIND-THE-EAR HEARING AID MODEL 48 PP PC

K892336 is the FDA 510(k) clearance for BEHIND-THE-EAR HEARING AID MODEL 48 PP PC by Qualitone. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K892336 · Qualitone · Ear, Nose, Throat device
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May 1989
Decision
44d
Days
Class 1
Risk

K892336 is an FDA 510(k) clearance for the BEHIND-THE-EAR HEARING AID MODEL 48 PP PC. 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 May 19, 1989 after a review of 44 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Qualitone devices

Submission Details

510(k) Number K892336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date May 19, 1989
Days to Decision 44 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
45d faster than avg
Panel avg: 89d · This submission: 44d
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 K892336.
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · Resound Corp. · Aug 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · Qualitone · Aug 1989
PERSONAL AMPLIFIER MODEL ULTRA HELIX
K893433 · Electone, Inc. · Jun 1989
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K892337 · Qualitone · May 1989
BEHIND-THE-EAR HEARING AID MODEL 408 W-H
K891251 · Siemens Hearing Instruments, Inc. · Mar 1989
RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE
K891011 · Resound Corp. · Mar 1989