Cleared Traditional

K833510 - PANASONIC WH-50 HEARING AID

K833510 is an FDA 510(k) clearance for PANASONIC WH-50 HEARING AID, manufactured by Panasonic Co. Div. Matsu Elec. Corp. America. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K833510 · Panasonic Co. Div. Matsu Elec. Corp. America · Ear, Nose, Throat device
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Nov 1983
Decision
34d
Days
Class 1
Risk

K833510 is an FDA 510(k) clearance for the PANASONIC WH-50 HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Panasonic Co. Div. Matsu Elec. Corp. America (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 34 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 Panasonic Co. Div. Matsu Elec. Corp. America devices

FDA 510(k) Submission Details - K833510

510(k) Number K833510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date November 14, 1983
Days to Decision 34 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
56d faster than avg
Panel avg: 90d · This submission: 34d
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 954
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K833510.
HEARING AID, UNITRON UT1
K833614 · Unitron Industries, Inc. · Nov 1983
HEARING AID UNITRON UI3
K833615 · Unitron Industries, Inc. · Nov 1983
RIONET HEARING AID HB-345
K833134 · Rion Acoustic Instruments, Inc. · Nov 1983
DAHLBERG #USS IN THE EAR HEARING AID
K833073 · Dahlberg Electronics, Inc. · Oct 1983
REXTON RX10, RX20-30 & 40
K832180 · Rexton, Inc. · Sep 1983
BEHIND-THE-EAR #123 AGCI
K832326 · Danavox, Inc. · Sep 1983