Cleared Traditional

K955288 - HEARING AID IMPRESSION MATERIAL

K955288 is an FDA 510(k) clearance for HEARING AID IMPRESSION MATERIAL, manufactured by Crown Delta Corp.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K955288 · Crown Delta Corp. · Ear, Nose, Throat device
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Feb 1996
Decision
78d
Days
Class 1
Risk

K955288 is an FDA 510(k) clearance for the HEARING AID IMPRESSION MATERIAL. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Crown Delta Corp. (Yorktown Heights, US). The FDA issued a Cleared decision on February 2, 1996 after a review of 78 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 Crown Delta Corp. devices

FDA 510(k) Submission Details - K955288

510(k) Number K955288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date February 02, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 90d · This submission: 78d
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 928
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K955288.
SONATA U-01
K955702 · Electone, Inc. · Feb 1996
DYNAMEQ-II OPTION
K955466 · Qualitone · Feb 1996
WIDEX MODEL SENSO DIGITAL (C8)
K955878 · Widex Hearing Aid Co., Inc. · Feb 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867 · Resound Corp. · Feb 1996
MIRACLE EAR MIRAGE
K954119 · Miracle-Ear, Inc. · Jan 1996
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS
K954922 · Rexton, Inc. · Jan 1996