Cleared Traditional

K830790 - PERSONAL AMPLIFIER MODULE

K830790 is the FDA 510(k) clearance for PERSONAL AMPLIFIER MODULE by Electone, Inc.. 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.

K830790 · Electone, Inc. · Ear, Nose, Throat device
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Jul 1983
Decision
120d
Days
Class 1
Risk

K830790 is an FDA 510(k) clearance for the PERSONAL AMPLIFIER MODULE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 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 Electone, Inc. devices

Submission Details

510(k) Number K830790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date July 12, 1983
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 K830790.
HEARING AID UNITRON #UE8-D
K831883 · Unitron Industries, Inc. · Aug 1983
PHONIC EAR PE 845PPC-D
K832081 · Phonic Ear, Inc. · Aug 1983
HEARING AID G3H & G3T
K832129 · Widex Hearing Aid Co., Inc. · Jul 1983
RIONET HEARING AID -AND/OR RION
K831721 · Rion Acoustic Instruments, Inc. · Jul 1983
WIDEX HEARING AID #G2H & G2T
K830465 · Widex Hearing Aid Co., Inc. · May 1983
MODEL 343D HEARING AID
K831197 · Telex Communications, Inc. · May 1983