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Sonic Innovations, Inc.

USA · Somerset

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

2active device licences

Class II 2

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 States0 registration records, 1 510(k), 0 PMA, 9 excluded

Brazil2 confirmed, 0 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: SONIC INNOVATIONS CANADA A DIVISION OF AUDMET CANADA LTD. · SONIC INNOVATIONS, INC. · SONIC INNOVATION, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K984518	SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL	1999-03-12
BR	10356029020	APARELHO AUDITIVO INTRAARICULAR ENCHANT	Class II
BR	10356020117	FAMILIA ENCHANT E/OU CAPTIVATE RETROAURICULAR	Class II
CA	14000	SONIC INNOVATIONS NATURA HEARING AID	Class II
CA	15216	SONIC INNOVATIONS CONFORMA HEARING AID	Class II

Sonic Innovations, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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