Cleared Traditional

K893528 - OTICON I22P CUSTOM FULL CONCHA (ITE) HR...

K893528 is the FDA 510(k) clearance for OTICON I22P CUSTOM FULL CONCHA (ITE) HR... by Oticon Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K893528 · Oticon Corp. · Ear, Nose, Throat device
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Aug 1989
Decision
99d
Days
Class 1
Risk

K893528 is an FDA 510(k) clearance for the OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Oticon Corp. (Somerset, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 99 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 Oticon Corp. devices

Submission Details

510(k) Number K893528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date August 15, 1989
Days to Decision 99 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
10d slower than avg
Panel avg: 89d · This submission: 99d
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 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K893528.
DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
K896159 · Dahlberg Electronics, Inc. · Jan 1990
3M INSTANT FIT CUSTOM EARMOLD
K895134 · 3M Company · Oct 1989
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140 · Oticon Corp. · Oct 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · Electone, Inc. · Aug 1989
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3
K893927 · Resound Corp. · Aug 1989
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI
K892338 · Qualitone · Aug 1989