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)

MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID

K-Number: K864030 · 1986-11-13

ApplicantInt'L Hearing Aids, Inc.
Decision Date1986-11-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Int'L Hearing Aids, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K864030. 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 MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID?

MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Int'L Hearing Aids, Inc.. The 510(k) number is K864030.

When did MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID receive FDA 510(k) clearance?

MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864030.

Who is the listed applicant for MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID?

The FDA 510(k) record lists Int'L Hearing Aids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID?

The FDA product code for MODEL AJ8183 CUSTOM-IN-THE-EAR 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 Int'L Hearing Aids, 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.

K873799INTERNATIONAL MODEL XL BEHIND-THE-EARK873798INTERNATIONAL MODEL XP BEHIND-THE-EARK873800INTERNATIONAL MODEL XM BEHIND-THE-EARK872647INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EARK864028MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AIDK864031MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID

View all 21 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.

↑