Device class
Class II
Regulation 874.3335
Total clearances
5
2024-09-12 → 2026-07-31
Definition
What is Air-Conduction Hearing Aid Software
Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.
Classification details
Medical specialty
Ear, Nose, Throat
Regulation number
874.3335
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Apple, Inc.
|
1 |
0 |
2024-09-12 |
|
Meta Platform Technologies, LLC |
1 |
1 |
2026-07-13 |
|
Luxottica Group S.P.A. |
1 |
0 |
2025-01-31 |
|
Tuned , Ltd. |
1 |
1 |
2025-09-26 |
|
Samsung Electronics Co., Ltd.
|
1 |
1 |
2026-07-31 |
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 |
| 92594 |
CPT
|
— |
High
|
CPT for hearing aid fitting and adjustment including programming of audio device |
Pulse
Most recent 510(k) clearances