Cleared Traditional

LYRIC HEARING AID

K081136 · Insound Medical, Inc. · Ear, Nose, Throat

May 2008

Decision

17d

Days

Class 1

Risk

About This 510(k) Submission

K081136 is an FDA 510(k) clearance for the LYRIC HEARING AID, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Insound Medical, Inc. (Newark, US). The FDA issued a Cleared decision on May 8, 2008, 17 days after receiving the submission on April 21, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K081136 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2008
Decision Date	May 08, 2008
Days to Decision	17 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.