Cleared Traditional

K905555 - A-ZILICONE

K905555 is the FDA 510(k) clearance for A-ZILICONE by Oticon Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 573-day FDA review.

K905555 · Oticon Corp. · Ear, Nose, Throat device
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Jul 1992
Decision
573d
Days
Class 1
Risk

K905555 is an FDA 510(k) clearance for the A-ZILICONE. 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 July 6, 1992 after a review of 573 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Oticon Corp. devices

Submission Details

510(k) Number K905555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date July 06, 1992
Days to Decision 573 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
484d slower than avg
Panel avg: 89d · This submission: 573d
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 K905555.
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388 · Oticon Corp. · Aug 1992
BTE HEARING AID PERSONIC 410
K923490 · Oticon Corp. · Aug 1992
BTE HEARING AID PERSONIC 425
K923491 · Oticon Corp. · Aug 1992
OTOSONIC ACS K
K922827 · Beltone Electronics Corp. · Jul 1992
WIDEX MODEL D32
K922708 · Widex Hearing Aid Co., Inc. · Jun 1992
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
K922301 · Beltone Electronics Corp. · Jun 1992