LXB · Hearing Aid, Bone Conduction
Ear, Nose, Throat · 21 CFR 874.3302 · Class 2
Overview
| Product Code | LXB |
|---|---|
| Device Name | Hearing Aid, Bone Conduction |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 51)
Showing 20 most recent of 51 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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) | Zdeer Technology (Henan) Co., Ltd. | Jun 15, 2026 | SESE |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | Jun 11, 2026 | SESE |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | May 29, 2025 | SESE |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | Apr 25, 2025 | SESE |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | Dec 16, 2021 | SESE |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | Sep 29, 2021 | SESE |
| K211640 | Ponto 5 Mini | Oticon Medical AB | Aug 10, 2021 | SESE |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | Feb 23, 2021 | SESE |
| K190540 | Ponto 4 | Oticon Medical AB | May 2, 2019 | SESE |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | Apr 27, 2018 | SESE |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | Jun 7, 2017 | SESE |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | Sep 29, 2016 | SESE |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | Jun 16, 2016 | SESE |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | May 20, 2016 | SESE |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | Mar 2, 2016 | SESE |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | Jul 22, 2015 | SESE |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | Mar 25, 2015 | SESE |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | Dec 9, 2013 | SESE |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | Nov 22, 2013 | SESE |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | Cochlear Americas | Nov 7, 2013 | SESE |
Top Applicants
- Cochlear Americas — 12 clearances
- Oticon Medical AB — 8 clearances
- Xomed, Inc. — 6 clearances
- Entific Medical Systems, Inc. — 5 clearances
- Sophono, Inc. — 5 clearances
