Cleared Traditional

K842980 - IN-THE-EAR-CANAL HEARING AID

K842980 is an FDA 510(k) clearance for IN-THE-EAR-CANAL HEARING AID, manufactured by Ear Care Hearing Systems, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K842980 · Ear Care Hearing Systems, Inc. · Ear, Nose, Throat device
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Sep 1984
Decision
37d
Days
Class 1
Risk

K842980 is an FDA 510(k) clearance for the IN-THE-EAR-CANAL HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Ear Care Hearing Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 37 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 Ear Care Hearing Systems, Inc. devices

FDA 510(k) Submission Details - K842980

510(k) Number K842980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date September 05, 1984
Days to Decision 37 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
52d faster than avg
Panel avg: 89d · This submission: 37d
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 K842980.
RIONET HEARING AID HB-34AS
K844059 · Rion Acoustic Instruments, Inc. · Dec 1984
PERSONAL AMPLIFIER SILENCER
K843980 · Electone, Inc. · Nov 1984
RIONET HEARING AID HB-73
K844000 · Rion Acoustic Instruments, Inc. · Nov 1984
TCA HEARING AID
K843067 · Telex Communications, Inc. · Sep 1984
RIONET HEARING AID HB-35
K842875 · Rion Acoustic Instruments, Inc. · Aug 1984
EARETTE HEARING AID OTICON E31V
K842073 · Oticon Corp. · Aug 1984