BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
Device Facts
| Record ID | K011438 |
|---|---|
| Device Name | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
| Applicant | Entific Medical Systems, Inc. |
| Product Code | LXB · Ear, Nose, Throat |
| Decision Date | Jul 23, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
