Oticon, Inc.

Somerset, NJ, US

OTICON, INC. appears in FDA device records in Somerset, NJ. FDA records list 68 510(k) clearances between 1978-02-21 and 2014-03-18, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 68
PMA records: 0
Recall records: 0
Registered establishments: 2

510(k) clearance history

Showing 50 of 68

FDA records hold 68 510(k) clearances for Oticon, Inc. between 1978 and 2014. The busiest year on record is 1986, with 7. The most recent is 2014, with 1.

Clearances by year, as a table

510(k) clearance decisions for Oticon, Inc., by decision year
Year	Clearances
1978	3
1979	3
1980	6
1981	6
1982	2
1983	1
1984	3
1985	4
1986	7
1987	5
1988	1
1989	4
1990	6
1992	4
1993	2
1995	4
1996	4
1997	2
2014	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K133308	TINNITUS SOUNDSUPPORT	KLW	Substantially Equivalent	2014-03-18
K973886	OTICON DIGISOUND COMPACT	ESD	Substantially Equivalent	1997-11-04
K973885	OTICON DIGISOUND ITE	ESD	Substantially Equivalent	1997-11-04
K964683	DIGIFOCUS ITE	ESD	Substantially Equivalent	1996-12-12
K963788	PRIMOFOCUS COMPACT	ESD	Substantially Equivalent	1996-11-27
K961059	DIGIFOCUS COMPACT	ESD	Substantially Equivalent	1996-05-07
K960284	OTICON /PRIMOFOCUS (PF)	ESD	Substantially Equivalent	1996-03-07
K954794	OTICON	ESD	Substantially Equivalent	1995-11-13
K951002	AMENDMENTS TO MULTIFOCUS	ESD	Substantially Equivalent	1995-09-18
K950381	OTICON/LOGIC	ESD	Substantially Equivalent	1995-02-27
K946045	OTICON	ESD	Substantially Equivalent	1995-01-30
K933307	MULTIFOCUS COMPACT BTE HEARING AID	ESD	Substantially Equivalent	1993-08-23
K932670	OTICON MF	ESD	Substantially Equivalent	1993-08-05
K923491	BTE HEARING AID PERSONIC 425	ESD	Substantially Equivalent	1992-08-06
K923490	BTE HEARING AID PERSONIC 410	ESD	Substantially Equivalent	1992-08-06
K923388	BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER	ESD	Substantially Equivalent	1992-08-06
K905555	A-ZILICONE	ESD	Substantially Equivalent	1992-07-06
K904673	OTICAON BTE MODEL E34P	ESD	Substantially Equivalent	1990-11-01
K902559	CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P	ESD	Substantially Equivalent	1990-07-09
K902353	CUSTOM ITE HEARING AID MODELS F AND L	ESD	Substantially Equivalent	1990-06-14
K902352	CUSTOM ITE HEARING AID MODEL: H	ESD	Substantially Equivalent	1990-06-14
K902351	CUSTOM ITE HEARING AID MODELS C AND M	ESD	Substantially Equivalent	1990-06-14
K901292	OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44	ESD	Substantially Equivalent	1990-04-10
K895140	CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54	ESD	Substantially Equivalent	1989-10-11
K893528	OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID	ESD	Substantially Equivalent	1989-08-15
K890703	CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A	ESD	Substantially Equivalent	1989-03-17
K890704	BTE HEARING AID OTICON MODEL: E42P	ESD	Substantially Equivalent	1989-03-09
K874651	OTICON HEARING AID MODEL I52	ESD	Substantially Equivalent	1988-01-19
K874380	BTE HEARING AID OTICON MODEL E38P	ESD	Substantially Equivalent	1987-12-29
K874381	BTE HEARING AID OTICON MODEL E39PL	ESD	Substantially Equivalent	1987-12-23
K874744	OTICON MODEL I50 IN-THE-EAR HEARING AID	ESD	Substantially Equivalent	1987-12-10
K872372	BEHIND-THE-EAR HEARING AID OTICON E40	ESD	Substantially Equivalent	1987-07-31
K872017	BTE HEARING AID OTICON MODEL E30P	ESD	Substantially Equivalent	1987-06-08
K862981	OTICON I31 INITIALES HEARING AID	ESD	Substantially Equivalent	1986-10-15
K862980	OTICON I31 CITE HEARING AID	ESD	Substantially Equivalent	1986-08-26
K862623	I81 INITIALES	ESD	Substantially Equivalent	1986-08-07
K862624	I81 CITE	ERA	Substantially Equivalent	1986-08-01
K862622	I22 CITE	ESD	Substantially Equivalent	1986-08-01
K862621	I22 INITIALES	ERA	Substantially Equivalent	1986-08-01
K854742	OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE	ESD	Substantially Equivalent	1986-02-20
K851430	EARETTE HEARING AID(BEHIND THE EAR OTICON E37F	ESD	Substantially Equivalent	1985-05-29
K851429	EARETTE HEARING AID(BEHIND THE EAR OTICON E35F	ESD	Substantially Equivalent	1985-05-29
K850763	EARETTE HEARING AID OTICON E32U	ESD	Substantially Equivalent	1985-03-25
K850762	EARETTE HEARING AID OTICON MODEL E32S	ESD	Substantially Equivalent	1985-03-25
K842074	EARETTE HEARING AID OTICON E30V	ESD	Substantially Equivalent	1984-08-23
K842073	EARETTE HEARING AID OTICON E31V	ESD	Substantially Equivalent	1984-08-23
K841436	OTICON E28A	ESD	Substantially Equivalent	1984-06-27
K833803	OTICON, E26P	ESD	Substantially Equivalent	1983-12-08
K821987	EARETTE HEARING AID OPTICON MODEL E28P	ESD	Substantially Equivalent	1982-08-19
K821325	OTICON	ESD	Substantially Equivalent	1982-06-07

Registered establishments

FDA registered establishments for Oticon, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2240713	2240713	OTICON, INC.	580 Howard Avenue, SOMERSET, NJ 08873 US	2026	ESD KLW LRB OSM
3005465494	3005465494	Oticon A/S	Kongebakken 9, Smorum Hovedstaden DK-2765 DK	2026	ESD KLW LRB OSM

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain