4 catalogue numbers from 95463, listed by Cochlear Bone Anchored Solutions AB, Sweden, 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 Baha 5 SuperPower Actuator unit | Listed by | Cochlear Bone Anchored Solutions AB, Sweden |
| FDA product code | LXB |
| Device type | Hearing Aid, Bone Conduction |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3302 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-10-24 |
| Record revised | 2025-01-27 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 55 °C; Handling environment temperature 5 to 40 °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.