Cleared Traditional

PRISMA

K972998 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Sep 1997

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K972998 is an FDA 510(k) clearance for the PRISMA, 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 September 5, 1997, 24 days after receiving the submission on August 12, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K972998 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1997
Decision Date	September 05, 1997
Days to Decision	24 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.