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 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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 |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | Cochlear Americas | Sep 26, 2013 | SESE |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | Apr 8, 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
