Cleared Traditional

K820172 - PHONIC EAR MODEL PE 810S

K820172 is the FDA 510(k) clearance for PHONIC EAR MODEL PE 810S 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 34-day FDA review.

K820172 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Feb 1982
Decision
34d
Days
Class 1
Risk

K820172 is an FDA 510(k) clearance for the PHONIC EAR MODEL PE 810S. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Phonic Ear, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 34 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

Submission Details

510(k) Number K820172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1982
Decision Date February 24, 1982
Days to Decision 34 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
55d faster than avg
Panel avg: 89d · This submission: 34d
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 K820172.
RIONET HEARING AID HB-69AS
K820348 · Rion Acoustic Instruments, Inc. · Mar 1982
RIONET HEARING AID HB-71H
K820349 · Rion Acoustic Instruments, Inc. · Mar 1982
RIONET HEARING AID HB-71S
K820350 · Rion Acoustic Instruments, Inc. · Mar 1982
MODEL 343 HEARING AID
K820148 · Telex Communications, Inc. · Feb 1982
RIONET HEARING AID HI-62
K813546 · Rion Acoustic Instruments, Inc. · Jan 1982
PHONIC EAR MODEL PE805CD
K813583 · Phonic Ear, Inc. · Jan 1982