Cleared Traditional

LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE

K921656 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

May 1992

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K921656 is an FDA 510(k) clearance for the LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE, 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 May 8, 1992, 31 days after receiving the submission on April 7, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K921656 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 1992
Decision Date	May 08, 1992
Days to Decision	31 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.