Cleared Traditional

K832081 - PHONIC EAR PE 845PPC-D

K832081 is the FDA 510(k) clearance for PHONIC EAR PE 845PPC-D 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.

K832081 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Aug 1983
Decision
34d
Days
Class 1
Risk

K832081 is an FDA 510(k) clearance for the PHONIC EAR PE 845PPC-D. 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 August 1, 1983 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 K832081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 01, 1983
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 K832081.
DAHLBERG #USS IN THE EAR HEARING AID
K833073 · Dahlberg Electronics, Inc. · Oct 1983
WIDEX HEARING AID MODEL L1
K832376 · Widex Hearing Aid Co., Inc. · Sep 1983
HEARING AID UNITRON #UE8-D
K831883 · Unitron Industries, Inc. · Aug 1983
HEARING AID G3H & G3T
K832129 · Widex Hearing Aid Co., Inc. · Jul 1983
PERSONAL AMPLIFIER MODULE
K830790 · Electone, Inc. · Jul 1983
RIONET HEARING AID -AND/OR RION
K831721 · Rion Acoustic Instruments, Inc. · Jul 1983