Cleared Traditional

Lyric4 Hearing Aid

K232999 · Sonova AG · Ear, Nose, Throat

Apr 2024

Decision

202d

Days

Class 1

Risk

About This 510(k) Submission

K232999 is an FDA 510(k) clearance for the Lyric4 Hearing Aid, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Sonova AG (Staefa, CH). The FDA issued a Cleared decision on April 11, 2024, 202 days after receiving the submission on September 22, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K232999 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2023
Decision Date	April 11, 2024
Days to Decision	202 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.