Eargo 6
Eargo 6 is a self-fitting air-conduction hearing aid for adults aged 18 or older with perceived mild to moderate hearing impairment. It amplifies and transmits sound into the ear. The…
Eargo 6 is a self-fitting air-conduction hearing aid for adults aged 18 or older with perceived mild to moderate hearing impairment. It amplifies and transmits sound into the ear. The system includes left and right in-canal hearing aids, a charging case and a companion mobile app.
Users adjust the hearing aids to their needs through the app without a prior hearing test or professional fitting. App communication uses ultrasonic signals for fitting and control, with Bluetooth Low Energy for programming settings and firmware updates. On-device controls also allow program changes.
Listed Item
Eargo 6 Right HI
Charging and Controls
Each hearing aid has a microphone, accelerometer and rechargeable lithium-ion battery. The accelerometer supports controls without the app. The carrying case has its own rechargeable battery and charges the correctly seated hearing aids by near-field inductive charging. The right hearing instrument is one side of this paired system.
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Luxshare Electronic Technology (Kunshan) Ltd. | Kunshan | Jiangsu | Contract manufacturer | 1 |
| Maintek Computer (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Eargo Inc, United States |
|---|---|
| FDA product code | QUH |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K221698 |
| Record published | 2021-12-21 |
| Record revised | 2025-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-04-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99-0149-001 | In distribution | |
| 99-0150-001 | In distribution | |
| 99-0147-001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eargo SE | Eargo Inc | 16 |
| Soundwave Hearing | Soundwave Hearing, LLC | 14 |
| GN Hearing | GN Hearing A/S | 13 |
| Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | 12 |
| Eargo 5 | Eargo Inc | 12 |
| Eargo 8 | Eargo Inc | 11 |
| Lexie Hearing | Hearx SA | 11 |
| Sony | WS Audiology USA, Inc. | 5 |
| Eargo 7 | Eargo Inc | 3 |
| Sonova Brand (multiple brand) | Sonova AG | 3 |
| Audialnet | Huizhou Jinghao Medical Technology Co., Ltd. | 2 |
| hear.com | WS Audiology USA, Inc. | 2 |
Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221698 | 2022-12-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.