Cleared Traditional

K800269 - AUDIONICS PB MAX HEARING AID

K800269 is an FDA 510(k) clearance for AUDIONICS PB MAX HEARING AID, manufactured by Audionics Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800269 · Audionics Corp. · Ear, Nose, Throat device
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Feb 1980
Decision
20d
Days
Class 1
Risk

K800269 is an FDA 510(k) clearance for the AUDIONICS PB MAX HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Audionics Corp. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 20 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 Audionics Corp. devices

FDA 510(k) Submission Details - K800269

510(k) Number K800269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1980
Decision Date February 26, 1980
Days to Decision 20 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
69d faster than avg
Panel avg: 89d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

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 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K800269.
DAHLBERG #AZ BEHIND THE EAR HEARING AID
K800571 · Dahlberg Electronics, Inc. · Mar 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244 · Oticon Corp. · Mar 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181 · Dahlberg Electronics, Inc. · Feb 1980
OTICON MODEL E17VF EARETTE HEARING AID
K800283 · Oticon Corp. · Feb 1980
OTICON MODEL E19VF EARETTE HEARING AID
K800316 · Oticon Corp. · Feb 1980
RIONET HEARING AID HE-71
K800011 · Rion Acoustic Instruments, Inc. · Jan 1980