Device class
Class II
Regulation 874.3340
Total clearances
7
2020-07-29 → 2026-07-10
Definition
What is Active Implantable Bone Conduction Hearing System
An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.3340
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 69714 |
CPT
|
— |
High
|
Osseointegrated implant for bone conduction hearing device; direct code for implanted bone conduction system |
| 69710 |
CPT
|
— |
Medium
|
Implantation of bone-conduction hearing device; alternative procedural code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-10 |
K260902 |
Cochlear Americas
|
Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System |
| 2024-07-10 |
K240614 |
Oticon Medical AB
|
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS |
| 2024-04-18 |
K240155 |
Cochlear Americas
|
Cochlear Osia System |
| 2023-08-18 |
K231204 |
Cochlear
|
Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App |
| 2022-07-27 |
K220922 |
Cochlear Americas
|
Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
| 2020-10-09 |
K201983 |
Med-El Elektromedizinische Geraete GmbH
|
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) |
| 2020-07-29 |
K200504 |
Med-El Elektromedizinische Geraete GmbH
|
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote |