Cleared Traditional

K832168 - PERSONAL AMPLIFIER

K832168 is an FDA 510(k) clearance for PERSONAL AMPLIFIER, manufactured by Electone, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K832168 · Electone, Inc. · Ear, Nose, Throat device
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Nov 1983
Decision
138d
Days
Class 1
Risk

K832168 is an FDA 510(k) clearance for the PERSONAL AMPLIFIER. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Walker, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 138 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 Electone, Inc. devices

FDA 510(k) Submission Details - K832168

510(k) Number K832168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1983
Decision Date November 21, 1983
Days to Decision 138 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
49d slower than avg
Panel avg: 89d · This submission: 138d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K832168.
POST-AURICULAR HEARING AID
K840359 · Phonic Ear, Inc. · Feb 1984
HEARING AID
K833926 · Rion Acoustic Instruments, Inc. · Dec 1983
OTICON, E26P
K833803 · Oticon Corp. · Dec 1983
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