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)

LYRIC HEARING AID

K-Number: K081136 · 2008-05-08

ApplicantInsound Medical, Inc.
Decision Date2008-05-08
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LYRIC HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Insound Medical, Inc.. It received FDA 510(k) clearance on 2008-05-08 under 510(k) number K081136. 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 LYRIC HEARING AID?

LYRIC HEARING AID is a medical device that received FDA 510(k) clearance on 2008-05-08. The listed applicant is Insound Medical, Inc.. The 510(k) number is K081136.

When did LYRIC HEARING AID receive FDA 510(k) clearance?

LYRIC HEARING AID received FDA 510(k) clearance on 2008-05-08, under 510(k) number K081136.

Who is the listed applicant for LYRIC HEARING AID?

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

What is the FDA product code for LYRIC HEARING AID?

The FDA product code for LYRIC HEARING AID 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 Insound Medical, Inc. 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.

K021867INSOUND XT SERIES HEARING AID

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 AGK130790LYRIC2Phonak, LLCK021867INSOUND 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.

↑