Cleared Traditional

K961653 - PHONAK SONA P2

K961653 is the FDA 510(k) clearance for PHONAK SONA P2 by Phonak, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K961653 · Phonak, Inc. · Ear, Nose, Throat device

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May 1996

Decision

29d

Days

Class 1

Risk

K961653 is an FDA 510(k) clearance for the PHONAK SONA P2. 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 May 29, 1996 after a review of 29 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	K961653 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 1996
Decision Date	May 29, 1996
Days to Decision	29 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

60d faster than avg

Panel avg: 89d · This submission: 29d

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 K961653.

SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

K962170 · Siemens Hearing Instruments, Inc. · Jul 1996

IN-THE-EAR

K961827 · Qualitone · Jul 1996

RIONET HEARING AID HB53-K

K961907 · Authorized Hearing Systems, Inc. · Jul 1996

PHONAK PICONET2 P2 AZ

K961622 · Phonak, Inc. · May 1996

TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40

K961143 · Telex Communications, Inc. · May 1996

AM 400

K961084 · Electone, Inc. · Apr 1996

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K961653

Phonak, Inc.

Naperville, IL · US

FRANCIS KUK, PH.D.

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Ear, Nose, Throat

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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