Device class
—
Regulation —
Total clearances
6
2021-05-05 → 2023-10-17
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
GN Hearing A/S
|
1 |
0 |
2022-01-19 |
|
Bose Corporation |
1 |
0 |
2021-05-05 |
|
Kaz USA, Inc., A Helen of Troy Company |
1 |
0 |
2022-01-05 |
|
Wsaud A/S |
1 |
0 |
2022-08-12 |
|
Intricon Corporation |
1 |
0 |
2023-10-17 |
|
Mdhearingaid |
1 |
0 |
2022-08-04 |
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 |
| 92604 |
CPT
|
— |
High
|
Hearing aid evaluation; self-fitting air-conduction hearing aid |
| 92605 |
CPT
|
— |
High
|
Hearing aid fitting; includes programming and customization |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-10-17 |
K223911 |
Intricon Corporation
|
Lumen 155-SF |
| 2022-08-12 |
K220403 |
Wsaud A/S
|
Vibe SF Self-Fitting Hearing Aid |
| 2022-08-04 |
K220303 |
Mdhearingaid
|
MDHearingAid app, MDHearingAid Smart hearing aids |
| 2022-01-19 |
K213424 |
GN Hearing A/S
|
Jabra Enhance Plus |
| 2022-01-05 |
K212609 |
Kaz USA, Inc., A Helen of Troy Company
|
BHA100 Series Braun Clear Hearing Aid |
| 2021-05-05 |
K211008 |
Bose Corporation
|
Bose SoundControl Hearing Aids |