Cleared Traditional

K130790 - LYRIC2

K130790 is an FDA 510(k) clearance for LYRIC2, manufactured by Phonak, LLC. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K130790 · Phonak, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
97d
Days
Class 1
Risk

K130790 is an FDA 510(k) clearance for the LYRIC2. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Phonak, LLC (Washington, US). The FDA issued a Cleared decision on June 27, 2013 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Phonak, LLC devices

FDA 510(k) Submission Details - K130790

510(k) Number K130790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 90d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT01861704 Completed Interventional Industry-sponsored

Post-market Study to Capture Information Regarding Performance of Lyric2

Post-market Study to Capture Information Regarding Performance of Extended Wear Hearing Aid Lyric2 Compared to Lyric

177
Patients (actual)
1
Site
Single blind
Masking
Condition studied Hearing Loss
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Tanya Arbogast
Sponsor Phonak AG, Switzerland (industry)
Started 2011-04-01 → Primary completion 2012-01-01 → Completed 2012-04-01
Primary outcome
Immediate Refit Upon Device Removal
Secondary outcome
Device Comfort
View full study on ClinicalTrials.gov

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 953
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K130790.
Lyric4 Hearing Aid
K232999 · Sonova AG · Apr 2024
LYRIC HEARING AID
K081136 · Insound Medical, Inc. · May 2008
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · Siemens Hearing Instruments, Inc. · Apr 2001
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
K984518 · Sonic Innovations, Inc. · Mar 1999
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
K974751 · General Hearing Instruments, Inc. · Mar 1998
ARGOSY PROGRAMMABLE ONQUE
K974242 · Argosy Electronics · Jan 1998