# K172460: ADHEAR System

- Pathway: 510(k) (Traditional)
- Applicant: Med-El Elektromedizinische Geraete GmbH
- Decided: Apr 27, 2018 after 256 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: 8 generations back to K861971 (1986). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon, Audifon-USA, Inc. (2012) Summary page 4.
- K142907: Baha 5 Sound Processor, Cochlear Americas (2015) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient’s head with an elastic headband or an adhesive adapter that is placed behind the auricle. Indications: • 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/K172460
Methodology: https://510kreport.com/methodology