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Hearing Services, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 5 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class II 9

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 7 510(k), 0 PMA, 132 excluded

Brazil0 confirmed, 7 excluded

Canada9 confirmed, 17 excluded

Manufacturer names merged into this page: Unitron Hearing, a division of National Hearing Services Inc. · UNITRON HEARING, A DIVISION OF NATIONAL HEARING SERVICES INC.

FDA 510(k) clearances by year

11979 · K790737

11983 · K832701

21987 · K873003

11994 · K935719

11995 · K954937

12014 · K132965

FDA listed device types

Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Masker, Tinnitus 1Device, Assistive Listening 1Self-Fitting Air-Conduction Hearing Aid, Over The Counter 1Hearing Aid, Air-Conduction, Prescription 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K132965	SOLACE SOUND GENERATORS	2014-03-25
US	K954937	COAST HEARING CHS (CUSTOM HEARING SYSTEM)	1995-11-13
US	K935719	DAIL A HEARING SCREENING TEST	1994-07-07
CA	7143	UNITRON BEHIND-THE-EAR HEARING AID	Class II
CA	7149	UNITRON IN THE EAR HEARING AID	Class II
CA	74559	LORI MEDICAL BEHIND-THE-EAR HEARING AID	Class II

Hearing Services, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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