Cleared Traditional

K930805 - CE-9 IN-THE-EAR HEARING AID

K930805 is the FDA 510(k) clearance for CE-9 IN-THE-EAR HEARING AID 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 30-day FDA review.

K930805 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Mar 1993
Decision
30d
Days
Class 1
Risk

K930805 is an FDA 510(k) clearance for the CE-9 IN-THE-EAR HEARING AID. 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 March 18, 1993 after a review of 30 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 Starkey Laboratories, Inc. devices

Submission Details

510(k) Number K930805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1993
Decision Date March 18, 1993
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 89d · This submission: 30d
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 K930805.
ITE MODEL ADOBE 100 FULL CUSTOM
K931590 · Widex Hearing Aid Co., Inc. · May 1993
ITC MODEL ADOBE 100 CANAL
K931591 · Widex Hearing Aid Co., Inc. · May 1993
WIDEX MODEL DX HEARING AID
K930715 · Widex Hearing Aid Co., Inc. · Mar 1993
INTRA V AND SECRET EAR III
K930853 · Starkey Laboratories, Inc. · Mar 1993
AUDIOTONE MODEL A-98
K926091 · Miracle-Ear, Inc. · Feb 1993
MIRACLE-EAR MODEL HL
K926092 · Miracle-Ear, Inc. · Feb 1993