Hearing Aid, Bone Conduction

FDA product code LXB · 51 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.3302
Review panel: EN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1986-04-03 – 2026-08-19

LXB 2026-08-19

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

Applicant Shokz Health Global Limited

K number K253431

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LXB 2026-07-22

Ossiclear (Ossiclear System)

Applicant Sounduct

K number K254296

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LXB 2026-06-15

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)

Applicant Zdeer Technology (Henan) Co., Ltd.

K number K260452

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LXB 2026-06-11

Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

Applicant Shenzhen Magnet Technology Co., Ltd.

K number K261256

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LXB 2025-05-29

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

Applicant Cochlear

K number K250215

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LXB 2025-04-25

contact forte Alpha

Applicant Bhm-Tech Produktionsgesellschaft Mbh

K number K243041

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LXB 2021-12-16

Ponto 5 SuperPower

Applicant Oticon Medical AB

K number K213733

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LXB 2021-09-29

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

Applicant Cochlear Americas

K number K212136

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LXB 2021-08-10

Ponto 5 Mini

Applicant Oticon Medical AB

K number K211640

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LXB 2021-02-23

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

Applicant Cochlear Americas

K number K202048

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LXB 2019-05-02

Ponto 4

Applicant Oticon Medical AB

K number K190540

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LXB 2018-04-27

ADHEAR System

Applicant Med-El Elektromedizinische Geraete GmbH

K number K172460

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LXB 2017-06-07

Cochlear Baha SoundArc

Applicant Cochlear Americas

K number K171088

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LXB 2016-09-29

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

Applicant Oticon Medical AB

K number K161671

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LXB 2016-06-16

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

Applicant Sophono, Inc.

K number K153391

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LXB 2016-05-20

Baha 5 Power Sound Processor

Applicant Cochlear Americas

K number K161123

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LXB 2016-03-02

Baha 5 Super Power Sound Processor

Applicant Cochlear Americas

K number K153245

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LXB 2013-12-09

PONTO PLUS AND PONTO PLUS POWER

Applicant Oticon Medical AB

K number K132775

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LXB 2013-11-22

OTOMAG BONE CONDUCATION HEARING SYSTEM

Applicant Sophono, Inc.

K number K132189

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LXB 2013-11-07

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT

Applicant Cochlear Americas

K number K131240

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LXB 2013-09-26

COCHLEAR BAHA 4 SOUND PROCESSOR

Applicant Cochlear Americas

K number K132278

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LXB 2013-04-08

OTOMAG BONE CONDUCTION HEARING SYSTEM

Applicant Sophono, Inc.

K number K123962

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LXB 2012-11-01

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON

Applicant Audifon-USA, Inc.

K number K121793

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LXB 2011-06-21

SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL

Applicant Sonitus Medical, Inc.

K number K110831

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LXB 2011-06-15

PONTO PRO POWER

Applicant Oticon Medical AB

K number K103594

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LXB 2011-05-23

OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)

Applicant Sophono, Inc.

K number K102199

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LXB 2011-05-10

BAHA 3 POWER SOUND PROCESSOR

Applicant Cochlear Americas

K number K110996

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LXB 2011-01-14

SOUNDBITE HEARING SYSTEM BY SONITUS

Applicant Sonitus Medical, Inc.

K number K100649

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LXB 2010-07-13

BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT

Applicant Cochlear Americas

K number K100360

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LXB 2010-05-18

OTOMAG BONE CONDUCTION HEARING SYSTEM

Applicant Sophono, Inc.

K number K100193

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LXB 2009-07-29

PONTO PRO

Applicant Oticon Medical AB

K number K090996

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LXB 2009-06-17

COCHLEAR BAHA BP100

Applicant Cochlear Bone Anchored Systems AB

K number K090720

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LXB 2008-11-14

OBC BONE ANCHORED HEARING AID SYSTEM

Applicant Oticon Medical AB

K number K082108

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LXB 2008-08-28

BAHA INTENSO

Applicant Cochlear Americas

K number K081606

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LXB 2006-09-08

TRANSEAR BONE CONDUCTION HEARING AID

Applicant Ear Technology Corp.

K number K062404

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LXB 2005-07-01

TRANSEAR BONE CONDUCTION HEARING AID

Applicant United Hearing Systems, Inc.

K number K050653

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LXB 2004-08-26

BAHA DIVINO

Applicant Entific Medical Systems, Inc.

K number K042017

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LXB 2002-08-30

BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

Applicant Entific Medical Systems, Inc.

K number K021837

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LXB 2001-07-23

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

Applicant Entific Medical Systems, Inc.

K number K011438

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LXB 2000-10-17

HEADBAND FOR BAHA

Applicant Entific Medical Systems, Inc.

K number K002913

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LXB 1999-11-24

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

Applicant Entific Medical Systems, Inc.

K number K992872

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LXB 1996-08-09

NOBELPHARMA BONE ANCHORED HEARING AID

Applicant Nobelpharma USA, Inc.

K number K955713

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LXB 1996-04-12

SECOND EAR BONE CONDUCTION HEARING AID

Applicant Wordcomp International Communication Group (Wicg)

K number K953872

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LXB 1995-06-07

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

Applicant Hearing Innovations, Inc.

K number K951678

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LXB 1994-05-10

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229

Applicant Starkey Laboratories, Inc.

K number K935701

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LXB 1988-11-30

MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR

Applicant Xomed, Inc.

K number K884056

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LXB 1988-06-21

XOMED AUDIANT BONE CONDUCTOR

Applicant Xomed, Inc.

K number K881382

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LXB 1988-03-14

ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.

Applicant Xomed, Inc.

K number K875277

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LXB 1987-06-30

XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.

Applicant Xomed, Inc.

K number K872168

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LXB 1986-05-30

XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL

Applicant Xomed, Inc.

K number K861971

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LXB 1986-04-03

AUDIANT BONE CONDUCTOR OR A.B.C.

Applicant Xomed, Inc.

K number K855059

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