Hangzhou Acosound Technology Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 4 device types, 4 products catalogued.
Hangzhou Acosound Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Hearing Aid, Air-Conduction, Prescription, Hearing Aid, Air-Conduction, Over The Counter and 2 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011350813 |
| FEI number | 3011350813 |
| DUNS | 542986440 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 杭州爱听科技有限公司 |
|---|---|
| Unified social credit code | 9133011058028650XN |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 401, No.2 Building, No.1390 Cangxing Street, Yuhang |
| Postal code | 311100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Celesto-W–RIC-S, Leya-W-IF, Celesto-W-IF, TW-IF-P, Sonar Pro, Leya-W-RIC-M and 10 more | 2022 | 52 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Class 2 | Leya-W-BTE-P, Celesto-W-BTE-P, Leya-W-BTE-H, Celesto-W-BTE-H | 2022 | 29 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Leya-RIC-M, AI-1, Leya-IF-P, Leya-IF-P-N, Leya-BTE-P-N, Leya-IF and 19 more | 2022 | 57 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Acomate M-10, Leya-BTE-P, Leya-BTE-H, Celesto-BTE-P, M-10, Celesto-BTE-H and 7 more | 2016 | 45 |
Own-Brand Listings
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-04-25 | Class III | Labeling design | Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer’s name is mislabeled as “Developed by AcoSound,” Correct should be “Manufactured by Hangzhou AcoSound.” And the labeling has no stat | 120 units |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Hearing aids – Ruby Series, Hearing aids – Sound Series, Hearing aids – LeYa Series, Hearing aids – LingXi Series, Hearing aids – Dolphin Series |
| Certifications | ICP Registration |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.