HEARING AID (IN-THE-EAR)— 510(k) K894428

Substantially Equivalent

Hearing Aid Express

FDA 510(k) clearance K894428 for HEARING AID (IN-THE-EAR), Substantially Equivalent on 1989-10-24. Applicant: Hearing Aid Express. Device class: 1.

Clearance details

Applicant: Hearing Aid Express
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1989-07-17
Decision date: 1989-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ESD

K232999 — Lyric4 Hearing Aid2024-04-11
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K081136 — LYRIC HEARING AID2008-05-08
K021867 — INSOUND XT SERIES HEARING AID2002-11-19
K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2001-04-24

More clearances from Hearing Aid Express

K942829 — HAE 11994-07-20
K942830 — HAE 31994-07-20
K942831 — HAE 21994-07-20
K894414 — HEARING AID (IN-THE-CANAL)1989-09-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.