Device class
—
Regulation —
Total clearances
8
2020-02-20 → 2026-08-13
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Sivantos GmbH |
1 |
1 |
2026-06-10 |
|
Levo Medical Corporation |
1 |
1 |
2026-08-13 |
|
Goldenear Company, Inc. |
1 |
0 |
2023-02-01 |
|
Duearity AB |
1 |
0 |
2023-06-30 |
|
Starkey Laboratories, Inc. |
1 |
0 |
2020-06-19 |
|
GN Hearing A/S
|
1 |
0 |
2020-02-20 |
|
Pnq Health |
1 |
0 |
2024-02-27 |
|
Aureliym GmbH |
1 |
0 |
2023-01-04 |
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 |
| 92625 |
CPT
|
— |
Medium
|
CPT for assessment and fitting of devices for tinnitus treatment |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-08-13 |
K260413 |
Levo Medical Corporation
|
Levo Gen 2 Tinnitus Therapy System |
| 2026-06-10 |
K260614 |
Sivantos GmbH
|
Tinnitus Therapy |
| 2024-02-27 |
K233435 |
Pnq Health
|
Peace N Quiet (0.7.0) |
| 2023-06-30 |
K223694 |
Duearity AB
|
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) |
| 2023-02-01 |
K221168 |
Goldenear Company, Inc.
|
Tinnitogram Signal Generator |
| 2023-01-04 |
K221125 |
Aureliym GmbH
|
SilentCloud |
| 2020-06-19 |
K201370 |
Starkey Laboratories, Inc.
|
Multiflex Tinnitus Technology |
| 2020-02-20 |
K193303 |
GN Hearing A/S
|
Tinnitus Sound Generator Module |