AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON— 510(k) K121793

Clearance details

Applicant

Audifon-USA, Inc.

Product code

Code LXB

Device class

Class 2

Regulation

21 CFR 874.3302

Advisory panel

Ear, Nose, Throat

Date received

2012-06-19

Decision date

2012-11-01

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Debary, FL, US

• 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

• K130514 — AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT2013-11-21
• K130417 — AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S2013-09-12
• K083488 — JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT2009-02-19

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 →