Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LYRIC2

K-Number: K130790 · 2013-06-27

ApplicantPhonak, LLC
Decision Date2013-06-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LYRIC2 is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, LLC. It received FDA 510(k) clearance on 2013-06-27 under 510(k) number K130790. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYRIC2?

LYRIC2 is a medical device that received FDA 510(k) clearance on 2013-06-27. The listed applicant is Phonak, LLC. The 510(k) number is K130790.

When did LYRIC2 receive FDA 510(k) clearance?

LYRIC2 received FDA 510(k) clearance on 2013-06-27, under 510(k) number K130790.

Who is the listed applicant for LYRIC2?

The FDA 510(k) record lists Phonak, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYRIC2?

The FDA product code for LYRIC2 is ESD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Phonak, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123450PHONAK TINNITUS BALANCE

Related Devices (Code: ESD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232999Lyric4 Hearing AidSonova AGK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑