Cleared Traditional

POST-AURICULAR HEARING AID MODEL PE 600PPCH (K844862) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K844862 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Apr 1985
Decision
115d
Days
Class 1
Risk

K844862 is an FDA 510(k) clearance for the POST-AURICULAR HEARING AID MODEL PE 600PPCH. 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 April 8, 1985 after a review of 115 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 K844862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date April 08, 1985
Days to Decision 115 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
26d slower than avg
Panel avg: 89d · This submission: 115d
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.