Cleared Traditional

K864672 - PHONIC EAR MODELS PE 811CS AND PE 811CST

K864672 is an FDA 510(k) clearance for PHONIC EAR MODELS PE 811CS AND PE 811CST, 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 80-day FDA review.

K864672 · Phonic Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
80d
Days
Class 1
Risk

K864672 is an FDA 510(k) clearance for the PHONIC EAR MODELS PE 811CS AND PE 811CST. 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 February 20, 1987 after a review of 80 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 Phonic Ear, Inc. devices

FDA 510(k) Submission Details - K864672

510(k) Number K864672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date February 20, 1987
Days to Decision 80 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
10d faster than avg
Panel avg: 90d · This submission: 80d
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 K864672.
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS
K870434 · Telex Communications, Inc. · Mar 1987
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
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HEARING AID, UNITRON MODEL UM60
K870503 · Unitron Industries, Inc. · Mar 1987
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID
K864028 · Int'L Hearing Aids, Inc. · Nov 1986
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
K864029 · Int'L Hearing Aids, Inc. · Nov 1986
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID
K864030 · Int'L Hearing Aids, Inc. · Nov 1986