Xomed Audiant Bone Conductor W/Improved Aa Coil
FDA 510(k) K861971 · Xomed, Inc.
510(k) numberK861971
Submission
- Device name
- Xomed Audiant Bone Conductor W/Improved Aa Coil
- Applicant
- Xomed, Inc.
Jacksonville, FL, US - Received
- May 21, 1986
- Decision date
- May 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LXB – Hearing Aid, Bone Conduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3302
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…LXB · Traditional | Shokz Health Global Limited | 08/19/2026SE |
| K254296 | Ossiclear (Ossiclear System)LXB · Traditional | Sounduct | 07/22/2026SE |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…LXB · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/15/2026SE |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)LXB · Traditional | Shenzhen Magnet Technology Co., Ltd. | 06/11/2026SE |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…LXB · Traditional | Cochlear | 05/29/2025SE |
| K243041 | contact forte AlphaLXB · Traditional | Bhm-Tech Produktionsgesellschaft Mbh | 04/25/2025SE |
| K213733 | Ponto 5 SuperPowerLXB · Special | Oticon Medical AB | 12/16/2021SE |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB · Traditional | Cochlear Americas | 09/29/2021SE |
| K211640 | Ponto 5 MiniLXB · Special | Oticon Medical AB | 08/10/2021SE |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…LXB · Traditional | Cochlear Americas | 02/23/2021SE |
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Questions and answers
When was Xomed Audiant Bone Conductor W/Improved Aa Coil cleared by the FDA?
Xomed Audiant Bone Conductor W/Improved Aa Coil (K861971) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 9 days after the submission was received.
What is the product code of K861971?
The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.