Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3302](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3302) → LXB — Hearing Aid, Bone Conduction # LXB · Hearing Aid, Bone Conduction _Ear, Nose, Throat · 21 CFR 874.3302 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB ## Overview - **Product Code:** LXB - **Device Name:** Hearing Aid, Bone Conduction - **Regulation:** [21 CFR 874.3302](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3302) - **Device Class:** 2 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) - **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](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K250215.md) | 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](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K243041.md) | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | Apr 25, 2025 | SESE | | [K213733](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K213733.md) | Ponto 5 SuperPower | Oticon Medical AB | Dec 16, 2021 | SESE | | [K212136](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K212136.md) | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | Sep 29, 2021 | SESE | | [K211640](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K211640.md) | Ponto 5 Mini | Oticon Medical AB | Aug 10, 2021 | SESE | | [K202048](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K202048.md) | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | Feb 23, 2021 | SESE | | [K190540](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K190540.md) | Ponto 4 | Oticon Medical AB | May 2, 2019 | SESE | | [K172460](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K172460.md) | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | Apr 27, 2018 | SESE | | [K171088](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K171088.md) | Cochlear Baha SoundArc | Cochlear Americas | Jun 7, 2017 | SESE | | [K161671](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K161671.md) | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | Sep 29, 2016 | SESE | | [K153391](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K153391.md) | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | Jun 16, 2016 | SESE | | [K161123](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K161123.md) | Baha 5 Power Sound Processor | Cochlear Americas | May 20, 2016 | SESE | | [K153245](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K153245.md) | Baha 5 Super Power Sound Processor | Cochlear Americas | Mar 2, 2016 | SESE | | [K150751](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K150751.md) | Cordelle II Sound Processor | Cochlear Americas | Jul 22, 2015 | SESE | | [K142907](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K142907.md) | Baha 5 Sound Processor | Cochlear Americas | Mar 25, 2015 | SESE | | [K132775](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K132775.md) | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | Dec 9, 2013 | SESE | | [K132189](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K132189.md) | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | Nov 22, 2013 | SESE | | [K131240](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K131240.md) | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | Cochlear Americas | Nov 7, 2013 | SESE | | [K132278](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K132278.md) | COCHLEAR BAHA 4 SOUND PROCESSOR | Cochlear Americas | Sep 26, 2013 | SESE | | [K123962](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K123962.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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