Cleared Traditional

K901833 - CE-8 CUSTOM IN-THE-EAR HEARING AIDS

K901833 is the FDA 510(k) clearance for CE-8 CUSTOM IN-THE-EAR HEARING AIDS by Starkey Laboratories, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K901833 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Aug 1990
Decision
107d
Days
Class 1
Risk

K901833 is an FDA 510(k) clearance for the CE-8 CUSTOM IN-THE-EAR HEARING AIDS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K901833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date August 09, 1990
Days to Decision 107 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
18d slower than avg
Panel avg: 89d · This submission: 107d
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 400
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K901833.
HEARING AID, UNITRON MODEL UM60-UH
K904576 · Unitron Industries, Inc. · Dec 1990
OTICAON BTE MODEL E34P
K904673 · Oticon Corp. · Nov 1990
SERIES MCAXX (MODEL 851) ITE HEARING AID
K903583 · Maico Hearing Instruments, Inc. · Oct 1990
INTRA III AND INTRA IV HEARING AIDS
K901860 · Starkey Laboratories, Inc. · Jul 1990
CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
K902559 · Oticon Corp. · Jul 1990
CUSTOM ITE HEARING AID MODELS C AND M
K902351 · Oticon Corp. · Jun 1990