TPLC - Total Product Life Cycle

• Device: masker, tinnitus
• Product Code: KLW
• Regulation Number: 874.3400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AMPLISOUND HEARING PRODUCTS & SERVICES
	SUBSTANTIALLY EQUIVALENT	1
ANM ADAPTIVE NEUROMODULATION GMBH
	SUBSTANTIALLY EQUIVALENT	1
AUDIFON GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
AUDIFON-USA INC.
	SUBSTANTIALLY EQUIVALENT	3
AUDIOFON USA INC.
	SUBSTANTIALLY EQUIVALENT	1
AURELIYM GMBH
	SUBSTANTIALLY EQUIVALENT	1
DUEARITY AB
	SUBSTANTIALLY EQUIVALENT	1
GN HEARING A/S
	SUBSTANTIALLY EQUIVALENT	3
GN RESOUND A/S
	SUBSTANTIALLY EQUIVALENT	2
GOLDENEAR COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	1
HANSATON AKUSTIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU BETTERLIFE MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KW EAR LAB, INC
	SUBSTANTIALLY EQUIVALENT	1
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NEUROTHERAPIES RESET GMBH.
	SUBSTANTIALLY EQUIVALENT	1
OTICON A/S
	SUBSTANTIALLY EQUIVALENT	1
OTOHARMONICS CORP
	SUBSTANTIALLY EQUIVALENT	1
PHONAK LLC
	SUBSTANTIALLY EQUIVALENT	1
PNQ HEALTH
	SUBSTANTIALLY EQUIVALENT	1
SANUTHERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUND OPTIONS TINNITUS TREATMENTS INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUNDCURE INC
	SUBSTANTIALLY EQUIVALENT	1
SOUNDCURE, INC.
	SUBSTANTIALLY EQUIVALENT	1
STARKEY LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
STARKEY LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TURTLE BEACH CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
UNITRON HEARING
	SUBSTANTIALLY EQUIVALENT	1
WIDEX USA
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	2	2
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Information	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Tinnitus	2	2
Sleep Dysfunction	1	1
Diarrhea	1	1
Hearing Impairment	1	1