Cleared Traditional

LYRIC2

K130790 · Phonak, LLC · Ear, Nose, Throat

Jun 2013

Decision

97d

Days

Class 1

Risk

About This 510(k) Submission

K130790 is an FDA 510(k) clearance for the LYRIC2, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Phonak, LLC (Washington, Dc, US). The FDA issued a Cleared decision on June 27, 2013, 97 days after receiving the submission on March 22, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K130790 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2013
Decision Date	June 27, 2013
Days to Decision	97 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.