Cleared Traditional

K071462 - UNITY 2 HIA & PROBE ( FOR USE WITH UNIT...

K071462 is the FDA 510(k) clearance for UNITY 2 HIA & PROBE ( FOR USE WITH UNIT... by Siemens Hearing Instruments, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETW) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K071462 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
11d
Days
Class 2
Risk

K071462 is an FDA 510(k) clearance for the UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2). Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 5, 2007 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - 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 Siemens Hearing Instruments, Inc. devices

Submission Details

510(k) Number K071462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2007
Decision Date June 05, 2007
Days to Decision 11 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 89d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 7
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K071462.
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229 · Resound Corp. · Mar 1996
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE
K952098 · Siemens Hearing Instruments, Inc. · May 1995
DESKREM-1000
K943459 · Starkey Laboratories, Inc. · Oct 1994
PORTAREM 2000
K943460 · Starkey Laboratories, Inc. · Oct 1994
AUDIOMETER
K870337 · Bio-Logic Systems Corp. · Apr 1987
STARKET MODEL HMS
K844275 · Starkey Laboratories, Inc. · Dec 1984

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.