Device class
Class II
Regulation 874.3325
Total clearances
10
2022-10-30 → 2026-06-25
Definition
What is Self-Fitting Air-Conduction Hearing Aid, Over The Counter
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 an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.
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 |
|
Nuheara Limited |
1 |
0 |
2022-10-30 |
|
Wsaud A/S |
1 |
0 |
2024-02-09 |
|
Concha Labs |
1 |
0 |
2024-03-15 |
|
Tuned , Ltd. |
1 |
0 |
2023-09-08 |
|
Huizhou Jinghao Medical Technology Co., Ltd. |
1 |
0 |
2023-09-25 |
|
Sonova AG |
1 |
0 |
2023-06-16 |
|
Soundwave Hearing, LLC |
1 |
0 |
2023-10-26 |
|
GN Hearing A/S
|
1 |
1 |
2026-06-25 |
|
Eargo, Inc. |
1 |
0 |
2022-12-21 |
|
Hearx SA (Pty) , Ltd. |
1 |
0 |
2023-03-14 |
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 |
| 92592 |
CPT
|
— |
High
|
Standard CPT for hearing aid evaluation/fitting, including over-the-counter self-fitting systems |
| V5014 |
HCPCS
|
Repair/modification of a hearing aid ✓ CMS-verified description |
Medium
|
HCPCS for hearing aid (monaural/binaural); device supply code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-25 |
K254108 |
GN Hearing A/S
|
Jabra Enhance Select Self-fit (Jabra Enhance Select 550) |
| 2024-03-15 |
K233747 |
Concha Labs
|
Concha Sol Hearing Aids (CL-1001) |
| 2024-02-09 |
K233464 |
Wsaud A/S
|
WSA Self-Fitting Hearing Aid Gen 2 |
| 2023-10-26 |
K231550 |
Soundwave Hearing, LLC
|
Sontro® OTC Hearing Aids (AI) |
| 2023-09-25 |
K221052 |
Huizhou Jinghao Medical Technology Co., Ltd.
|
Self-Fitting hearing aids |
| 2023-09-08 |
K223848 |
Tuned , Ltd.
|
Intrisound Tuned Lumen® 155 Hearing Aids |
| 2023-06-16 |
K230538 |
Sonova AG
|
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid |
| 2023-03-14 |
K223137 |
Hearx SA (Pty) , Ltd.
|
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application |
| 2022-12-21 |
K221698 |
Eargo, Inc.
|
Eargo 5 , Eargo 6 |
| 2022-10-30 |
K221064 |
Nuheara Limited
|
Nuheara IQbuds 2 PRO Hearing Aid |