Cleared Traditional

K880335 - INTRA II SECRET EAR HEARING AIDS ISE

K880335 is the FDA 510(k) clearance for INTRA II SECRET EAR HEARING AIDS ISE 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 52-day FDA review.

K880335 · Starkey Laboratories, Inc. · Ear, Nose, Throat device
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Mar 1988
Decision
52d
Days
Class 1
Risk

K880335 is an FDA 510(k) clearance for the INTRA II SECRET EAR HEARING AIDS ISE. 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, 1988 after a review of 52 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 K880335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date March 18, 1988
Days to Decision 52 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
37d faster than avg
Panel avg: 89d · This submission: 52d
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 K880335.
STAR 22,33,66 SERIES & STARKEY H. AND SM SERIES
K880969 · Starkey Laboratories, Inc. · Apr 1988
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
K880333 · Starkey Laboratories, Inc. · Mar 1988
CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7
K880334 · Starkey Laboratories, Inc. · Mar 1988
WIDEX HEARING AID MODEL C1
K880273 · Widex Hearing Aid Co., Inc. · Mar 1988
MEMORYMATE HEARING AID MODEL 8200
K880082 · 3M Company · Mar 1988
ADDVANTAGE:TVC MARCON
K880284 · Richards Medical Co., Inc. · Feb 1988