Product Code: LXB FDA class 2 21 CFR 874.3302

Hearing Aid, Bone Conduction

Ear, Nose, Throat

The Bone Conduction Hearing Aid (product code LXB) is a hearing device that transmits sound vibrations through the bones of the skull to the cochlea, bypassing the outer and middle ear, and is used by individuals with conductive hearing loss or single-sided deafness. Regulated under 21 CFR 874.3302 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review. The device falls under the Ear, Nose, and Throat medical specialty. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LXB
Device Class: FDA class 2
Regulation Number: 874.3302
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260452	Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)	Jun 15, 2026	Substantially Equivalent	Zdeer Technology (Henan) Co., Ltd.
K261256	Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)	Jun 11, 2026	Substantially Equivalent	Shenzhen Magnet Technology Co., Ltd.
K250215	Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand	May 29, 2025	Substantially Equivalent	Cochlear
K243041	contact forte Alpha	Apr 25, 2025	Substantially Equivalent	Bhm-Tech Produktionsgesellschaft Mbh
K213733	Ponto 5 SuperPower	Dec 16, 2021	Substantially Equivalent	Oticon Medical AB
K212136	Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App	Sep 29, 2021	Substantially Equivalent	Cochlear Americas
K211640	Ponto 5 Mini	Aug 10, 2021	Substantially Equivalent	Oticon Medical AB
K202048	Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App	Feb 23, 2021	Substantially Equivalent	Cochlear Americas
K190540	Ponto 4	May 02, 2019	Substantially Equivalent	Oticon Medical AB
K172460	ADHEAR System	Apr 27, 2018	Substantially Equivalent	Med-El Elektromedizinische Geraete GmbH
K171088	Cochlear Baha SoundArc	Jun 07, 2017	Substantially Equivalent	Cochlear Americas
K161671	Ponto 3, Ponto 3 Power and Ponto 3 SuperPower	Sep 29, 2016	Substantially Equivalent	Oticon Medical AB
K153391	Sophono Bone Conduction Systems (S) Configuration and (M) Configuration	Jun 16, 2016	Substantially Equivalent	Sophono, Inc.
K161123	Baha 5 Power Sound Processor	May 20, 2016	Substantially Equivalent	Cochlear Americas
K153245	Baha 5 Super Power Sound Processor	Mar 02, 2016	Substantially Equivalent	Cochlear Americas
K150751	Cordelle II Sound Processor	Jul 22, 2015	Substantially Equivalent	Cochlear Americas
K142907	Baha 5 Sound Processor	Mar 25, 2015	Substantially Equivalent	Cochlear Americas
K132775	PONTO PLUS AND PONTO PLUS POWER	Dec 09, 2013	Substantially Equivalent	Oticon Medical AB
K132189	OTOMAG BONE CONDUCATION HEARING SYSTEM	Nov 22, 2013	Substantially Equivalent	Sophono, Inc.
K131240	COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT	Nov 07, 2013	Substantially Equivalent	Cochlear Americas
K132278	COCHLEAR BAHA 4 SOUND PROCESSOR	Sep 26, 2013	Substantially Equivalent	Cochlear Americas
K123962	OTOMAG BONE CONDUCTION HEARING SYSTEM	Apr 08, 2013	Substantially Equivalent	Sophono, Inc.
K121793	AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON	Nov 01, 2012	Substantially Equivalent	Audifon-USA, Inc.
K110831	SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL	Jun 21, 2011	Substantially Equivalent	Sonitus Medical, Inc.
K103594	PONTO PRO POWER	Jun 15, 2011	Substantially Equivalent	Oticon Medical AB
K102199	OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)	May 23, 2011	Substantially Equivalent	Sophono, Inc.
K110996	BAHA 3 POWER SOUND PROCESSOR	May 10, 2011	Substantially Equivalent	Cochlear Americas
K100649	SOUNDBITE HEARING SYSTEM BY SONITUS	Jan 14, 2011	Substantially Equivalent	Sonitus Medical, Inc.
K100360	BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT	Jul 13, 2010	Substantially Equivalent	Cochlear Americas
K100193	OTOMAG BONE CONDUCTION HEARING SYSTEM	May 18, 2010	Substantially Equivalent	Sophono, Inc.
K090996	PONTO PRO	Jul 29, 2009	Substantially Equivalent	Oticon Medical AB
K090720	COCHLEAR BAHA BP100	Jun 17, 2009	Substantially Equivalent	Cochlear Bone Anchored Systems AB
K082108	OBC BONE ANCHORED HEARING AID SYSTEM	Nov 14, 2008	Substantially Equivalent	Oticon Medical AB
K081606	BAHA INTENSO	Aug 28, 2008	Substantially Equivalent	Cochlear Americas
K062404	TRANSEAR BONE CONDUCTION HEARING AID	Sep 08, 2006	Substantially Equivalent	Ear Technology Corp.
K050653	TRANSEAR BONE CONDUCTION HEARING AID	Jul 01, 2005	Substantially Equivalent	United Hearing Systems, Inc.
K042017	BAHA DIVINO	Aug 26, 2004	Substantially Equivalent	Entific Medical Systems, Inc.
K021837	BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)	Aug 30, 2002	Substantially Equivalent	Entific Medical Systems, Inc.
K011438	BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.	Jul 23, 2001	Substantially Equivalent	Entific Medical Systems, Inc.
K002913	HEADBAND FOR BAHA	Oct 17, 2000	Substantially Equivalent	Entific Medical Systems, Inc.
K992872	BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II	Nov 24, 1999	Substantially Equivalent	Entific Medical Systems, Inc.
K955713	NOBELPHARMA BONE ANCHORED HEARING AID	Aug 09, 1996	Substantially Equivalent	Nobelpharma USA, Inc.
K953872	SECOND EAR BONE CONDUCTION HEARING AID	Apr 12, 1996	Substantially Equivalent	Wordcomp International Communication Group (Wicg)
K951678	HI SONIC 2000 DIGITAL HEARING INSTRUMENT	Jun 07, 1995	Substantially Equivalent	Hearing Innovations, Inc.
K935701	VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229	May 10, 1994	Substantially Equivalent	Starkey Laboratories, Inc.
K884056	MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR	Nov 30, 1988	Substantially Equivalent	Xomed, Inc.
K881382	XOMED AUDIANT BONE CONDUCTOR	Jun 21, 1988	Substantially Equivalent	Xomed, Inc.
K875277	ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.	Mar 14, 1988	Substantially Equivalent	Xomed, Inc.
K872168	XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.	Jun 30, 1987	Substantially Equivalent	Xomed, Inc.
K861971	XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL	May 30, 1986	Substantially Equivalent	Xomed, Inc.
K855059	AUDIANT BONE CONDUCTOR OR A.B.C.	Apr 03, 1986	Substantially Equivalent	Xomed, Inc.