Cleared Traditional

K844861 - POST-AURICULAR HEARING AID MODEL PE 600...

K844861 is the FDA 510(k) clearance for POST-AURICULAR HEARING AID MODEL PE 600... by Phonic Ear, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K844861 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Mar 1985
Decision
103d
Days
Class 1
Risk

K844861 is an FDA 510(k) clearance for the POST-AURICULAR HEARING AID MODEL PE 600PPCL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Phonic Ear, Inc. (Mill Valley, US). The FDA issued a Cleared decision on March 27, 1985 after a review of 103 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 Phonic Ear, Inc. devices

Submission Details

510(k) Number K844861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date March 27, 1985
Days to Decision 103 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
14d slower than avg
Panel avg: 89d · This submission: 103d
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 K844861.
POST-AURICULAR HEARING AID MODEL PE 600 PPC
K844859 · Phonic Ear, Inc. · Mar 1985
POST-SURICULAR HEARING AID PE 600CD
K844863 · Phonic Ear, Inc. · Mar 1985
POST-AURICULAR HEARING AID MODEL PE 600CHD
K844860 · Phonic Ear, Inc. · Mar 1985
HEARING AID 365
K850243 · Telex Communications, Inc. · Mar 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · Oticon Corp. · Mar 1985
EARETTE HEARING AID OTICON E32U
K850763 · Oticon Corp. · Mar 1985