Cleared Traditional

K963958 - IMPRESS

K963958 is the FDA 510(k) clearance for IMPRESS by Beltone Electronics Corp.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K963958 · Beltone Electronics Corp. · Ear, Nose, Throat device
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Dec 1996
Decision
64d
Days
Class 1
Risk

K963958 is an FDA 510(k) clearance for the IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Beltone Electronics Corp. (Chicago, US). The FDA issued a Cleared decision on December 5, 1996 after a review of 64 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 Beltone Electronics Corp. devices

Submission Details

510(k) Number K963958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date December 05, 1996
Days to Decision 64 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
25d faster than avg
Panel avg: 89d · This submission: 64d
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 K963958.
DAHLBERG K-AMP BTE
K964794 · Miracle-Ear, Inc. · Dec 1996
AHS OMEGA CONCEPT
K963877 · Authorized Hearing Systems, Inc. · Dec 1996
AHS OMEGA HF
K963878 · Authorized Hearing Systems, Inc. · Dec 1996
PHONAK MICROLINK, PERSONAL FM RECEIVER
K964035 · Phonak, Inc. · Dec 1996
PRIMOFOCUS COMPACT
K963788 · Oticon Corp. · Nov 1996
AHS OMEGA K-AMP
K963875 · Authorized Hearing Systems, Inc. · Nov 1996