FDA Registration Number: 3018100871

Last Validated: May 21, 2024

Status: Valid

Valid2024 U.S. FDA Medical Device Establishment Registration


Establishment Information

190 Aberdeen Street
Perth Western Australia, AU 6003

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH Valid May 20, 2024

Device Listing

Device Name

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Product Code


Company Function(s)

Manufacturer, Specification Developer

Proprietary Name(s)

OTC Hearing Aid

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