# K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon

- Pathway: 510(k) (Abbreviated)
- Applicant: Audifon-USA, Inc.
- Decided: Nov 1, 2012 after 135 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: 1 generation back to K935701 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935701: Viennatone an, Viennatone as Fidelity F228, Fidelity F229, Starkey Laboratories, Inc. (1994) Summary page 1.

## Most influential descendants
- K172460: ADHEAR System (2018), 1 descendant of its own
- 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) (2026), 0 descendants of its own
- K261256: Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (2026), 0 descendants of its own

## Indications for use
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional. The target populations for the devices are as follows: AN-Evol adults and children ( 12 years) contact star evol adults and children ( 12 years) contact mini adults and children (8 months) apollon adults and children ( 12 years) The apollon is a device where it is capable of utilizing either air or bone conduction.

Source page: https://510kreport.com/device/K121793
Methodology: https://510kreport.com/methodology