Device class
Class II
Regulation 874.3325
Total clearances
6
2021-05-05 → 2023-10-17
Definition
What is Self-Fitting Air-Conduction Hearing Aid, Prescription
A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.3325
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Wsaud A/S |
1 |
0 |
2022-08-12 |
|
Intricon Corporation |
1 |
0 |
2023-10-17 |
|
Mdhearingaid |
1 |
0 |
2022-08-04 |
|
Kaz USA, Inc., A Helen of Troy Company |
1 |
0 |
2022-01-05 |
|
GN Hearing A/S
|
1 |
0 |
2022-01-19 |
|
Bose Corporation |
1 |
0 |
2021-05-05 |
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 |