Cleared Traditional

SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

K984518 · Sonic Innovations, Inc. · Ear, Nose, Throat

Mar 1999

Decision

81d

Days

Class 1

Risk

About This 510(k) Submission

K984518 is an FDA 510(k) clearance for the SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Sonic Innovations, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 12, 1999, 81 days after receiving the submission on December 21, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K984518 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 1998
Decision Date	March 12, 1999
Days to Decision	81 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.