Device class
Class II
Regulation 874.1050
Total clearances
4
2022-06-22 → 2024-06-21
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.1050
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Otodynamics |
2 |
0 |
2024-06-21 |
|
Path Medical GmbH
|
1 |
0 |
2022-06-22 |
|
Hearx SA (Pty) , Ltd. |
1 |
0 |
2023-10-27 |
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 |
| 92552 |
CPT
|
— |
High
|
CPT code for pure tone audiometry including air and bone conduction |
| 92553 |
CPT
|
— |
Medium
|
CPT code for audiometric testing with speech discrimination |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-06-21 |
K234095 |
Otodynamics
|
OtoNova/OtoNova Pro |
| 2024-03-15 |
K240430 |
Otodynamics, Ltd.
|
Otoport Pro |
| 2023-10-27 |
K231545 |
Hearx SA (Pty) , Ltd.
|
hearOAE |
| 2022-06-22 |
K213345 |
Path Medical GmbH
|
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE |