Audiant Bone Conductor at The Ear Sound Pro
by Xomed, Inc.
510(k) K872168
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872168 | Date30 Jun 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Xomed Audiant Bone Conductor at the Ear Sound Pro.
- 510(k) Number
- FDA Product Code
- LXB
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3302
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Audiant Bone Conductor at The Ear Sound Pro is a Hearing Aid, Bone Conduction device designed to transmit sound vibrations through the bones of the skull to the inner ear, bypassing external ear structures. It is intended for patients with conductive hearing loss, single-sided deafness, or those who cannot tolerate traditional earwear, providing auditory stimulation via direct bone conduction.
This device is supplied as a reusable medical instrument and falls under Class II – Special Controls regulatory classification (FDA product code LXB). Cleared by the FDA under 510(k) K872168 in 1987, it is intended for use in clinical settings such as otolaryngology. No sterility or single-use specifications are noted in the regulatory submission, and MRI safety data is not provided. The device is authorized for distribution in the United States.