Cleared Traditional

K844861 - POST-AURICULAR HEARING AID MODEL PE 600PPCL

K844861 is an FDA 510(k) clearance for POST-AURICULAR HEARING AID MODEL PE 600PPCL, manufactured by Phonic Ear, Inc.. The device is a Class 1 Ear, Nose, Throat device with 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

FDA 510(k) Submission Details - K844861

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
13d slower than avg
Panel avg: 90d · This submission: 103d
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 953
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
BODY HEARING AIDS MT 80 SP
K850185 · Robert Bosch Corp. · Mar 1985
BOSCH STARR 66PP -HEARING AIDS
K850187 · Robert Bosch Corp. · Mar 1985
BOSCH STAR 66PP-S HEARING AID
K850189 · Robert Bosch Corp. · Mar 1985