Cleared Traditional

K861857 - PHONIC EAR

K861857 is the FDA 510(k) clearance for PHONIC EAR by Phonic Ear, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETW) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K861857 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Jun 1986
Decision
26d
Days
Class 2
Risk

K861857 is an FDA 510(k) clearance for the PHONIC EAR. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Phonic Ear, Inc. (Mill Valley, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 K861857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1986
Decision Date June 09, 1986
Days to Decision 26 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
63d faster than avg
Panel avg: 89d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 9
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K861857.
PORTAREM 2000
K943460 · Starkey Laboratories, Inc. · Oct 1994
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987
PHONIC EAR, MODEL PE 1800
K862162 · Phonic Ear, Inc. · Jul 1986
STARKET MODEL HMS
K844275 · Starkey Laboratories, Inc. · Dec 1984
STARKEY MODEL HAL-1
K821908 · Starkey Laboratories, Inc. · Aug 1982