Catalogue number 34687, listed by Med-El Elektromedizinische Geräte Gesellschaft m.b.H., under Hearing Aid, Bone Conduction. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Adhear Audio Processor, Model 701, Terra Brown | Listed by | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| 510(k) | K172460 |
| Record published | 2018-06-27 |
| Record revised | 2025-07-31 (version 4) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment humidity 15 to 90 % RH; Storage environment humidity up to 90 % RH; Storage environment temperature -13 to 140 °F; Storage environment temperature -25 to 60 °C |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.