← Product Code [LXB](/productcode/LXB) · 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) (K260452)

_Zdeer Technology (Henan) Co., Ltd. · LXB · Jun 15, 2026 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260452

## Device Facts

- **Applicant:** Zdeer Technology (Henan) Co., Ltd.
- **Product Code:** [LXB](/productcode/LXB.md)
- **Decision Date:** Jun 15, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3302
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/device/K260452](https://fda.innolitics.com/device/K260452)

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