Cleared Traditional

K933042 - SILVER COMPRESSION MODULE

K933042 is the FDA 510(k) clearance for SILVER COMPRESSION 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 96-day FDA review.

K933042 · Electone, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
96d
Days
Class 1
Risk

K933042 is an FDA 510(k) clearance for the SILVER COMPRESSION MODULE, ITE. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 96 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 K933042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date August 02, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 89d · This submission: 96d
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 K933042.
BELTONE PRIMA 2000
K932703 · Beltone Electronics Corp. · Aug 1993
OTICON MF
K932670 · Oticon Corp. · Aug 1993
GOLD ASP MODULE, ITE
K933036 · Electone, Inc. · Aug 1993
PHONAK PICO-FORTE SC-2
K932734 · Phonak, Inc. · Jul 1993
PHONAK PICO-FORTE SC-D-2
K932735 · Phonak, Inc. · Jul 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
K933113 · Starkey Laboratories, Inc. · Jul 1993