ADHEAR System— 510(k) K172460

Clearance details

Applicant

Med-El Elektromedizinische Geraete GmbH

Product code

Code LXB

Device class

Class 2

Regulation

21 CFR 874.3302

Advisory panel

Ear, Nose, Throat

Date received

2017-08-14

Decision date

2018-04-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Innsbruck, AT

• K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)2026-08-19
• K254296 — Ossiclear (Ossiclear System)2026-07-22
• 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)2026-06-15
• K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)2026-06-11
• K250215 — Baha 7 Sound Processor +4 more2025-05-29

• K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)2020-10-09
• K200504 — BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote2020-07-29
• K191457 — BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)2019-09-18
• K183373 — Bonebridge2019-03-07
• DEN170009 — Bonebridge2018-07-20

Injury

2,334

Total

2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →