Cleared Traditional

FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT

K951828 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Jun 1995

Decision

71d

Days

Class 1

Risk

About This 510(k) Submission

K951828 is an FDA 510(k) clearance for the FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on June 30, 1995, 71 days after receiving the submission on April 20, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K951828 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 1995
Decision Date	June 30, 1995
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — 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.