Cleared Traditional

K924911 - PHONAK PICO-FORTE PP-SC-2 BTE HEARING I...

K924911 is the FDA 510(k) clearance for PHONAK PICO-FORTE PP-SC-2 BTE HEARING I... by Phonak, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K924911 · Phonak, Inc. · Ear, Nose, Throat device
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Nov 1992
Decision
36d
Days
Class 1
Risk

K924911 is an FDA 510(k) clearance for the PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT. 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 November 4, 1992 after a review of 36 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 K924911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1992
Decision Date November 04, 1992
Days to Decision 36 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
53d faster than avg
Panel avg: 89d · This submission: 36d
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 K924911.
WIDEX MODEL D8 (HEARING AID)
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P54-0 BEHIND THE EAR HEARING AID
K924887 · Electone, Inc. · Nov 1992
P54 HEARING AID
K924888 · Electone, Inc. · Nov 1992
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR
K924913 · Phonak, Inc. · Nov 1992
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT
K924914 · Phonak, Inc. · Nov 1992
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT
K924912 · Phonak, Inc. · Nov 1992