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)

MIRACLE-EAR ITE DIGITAL

K-Number: K972346 · 1997-07-23

ApplicantMiracle-Ear, Inc.
Decision Date1997-07-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MIRACLE-EAR ITE DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Miracle-Ear, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K972346. 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 MIRACLE-EAR ITE DIGITAL?

MIRACLE-EAR ITE DIGITAL is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Miracle-Ear, Inc.. The 510(k) number is K972346.

When did MIRACLE-EAR ITE DIGITAL receive FDA 510(k) clearance?

MIRACLE-EAR ITE DIGITAL received FDA 510(k) clearance on 1997-07-23, under 510(k) number K972346.

Who is the listed applicant for MIRACLE-EAR ITE DIGITAL?

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

What is the FDA product code for MIRACLE-EAR ITE DIGITAL?

The FDA product code for MIRACLE-EAR ITE DIGITAL 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 Miracle-Ear, 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.

K972345DAHLBERG/MIRACLE-EARK972344MIRACLE-EAR DIGITAL BTEK970262MULTI-CHANNEL COMPRESSION BTE (SD)K964419MIRACLE - EAR (ITE/ITC/CIC)K965049DAHLBERG (A-554)K965057AUDIOTONE (A554H)

View all 65 devices →

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, LLCK081136LYRIC 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.

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.

↑