Cleared Traditional

K915461 - PHONAK 9000-AF ITE HEARING INSTRUMENT S...

K915461 is the FDA 510(k) clearance for PHONAK 9000-AF ITE HEARING INSTRUMENT S... by Phonak, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K915461 · Phonak, Inc. · Ear, Nose, Throat device
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Dec 1991
Decision
26d
Days
Class 1
Risk

K915461 is an FDA 510(k) clearance for the PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Phonak, Inc. (Naperville, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 26 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 Phonak, Inc. devices

Submission Details

510(k) Number K915461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date December 30, 1991
Days to Decision 26 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 89d · This submission: 26d
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 K915461.
RIONET HEARING AID HB-53P
K920486 · Authorized Hearing Systems, Inc. · Feb 1992
AUDIOTONE MODEL A-96
K920093 · Miracle-Ear, Inc. · Jan 1992
RIONET HEARING AID HB-71K (K-AMP)
K915875 · Authorized Hearing Systems, Inc. · Jan 1992
OTOSONIC (OSI) LPS IN-THE-EAR HEARING AID
K914981 · Beltone Electronics Corp. · Nov 1991
BELTONE PROFILE IN-THE-EAR HEARING AID
K914982 · Beltone Electronics Corp. · Nov 1991
OTOSONIC ACS-ASP
K914939 · Beltone Electronics Corp. · Nov 1991