# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Zdeer Technology (Henan) Co., Ltd.
- Decided: Jun 15, 2026 after 124 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K861971 (1986). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172460: ADHEAR System, Med-El Elektromedizinische Geraete GmbH (2018) Summary page 5.
- K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon, Audifon-USA, Inc. (2012) Summary page 5.

## Indications for use
The device is a wearable, non-invasive, and non-implanted bone conduction hearing aid intended to treat patients of patients aged 12 years and older with conductive hearing loss or single-sided deafness. It utilizes an ear-hook design to ensure stable mechanical coupling between the transducer and the temporal bone. * Unilateral or bilateral conductive hearing loss, either chronic or temporary. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 25 dB HL. * Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

Source page: https://510kreport.com/device/K260452
Methodology: https://510kreport.com/methodology