Audio Service

Audio Service S_ITE TUNE T 2.0 QUIX G5 L BLK TBLU Hearing Aid

Registry build 21.09.26
45manufacturers in China registered for this device type
1,148catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (27), Fujian (9), Jiangsu (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ESD
Manufacturer City Province Registered as Device types
GN Resound China, Ltd. Xiamen Fujian Contract manufacturer 7
Xiamen Newsound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 7
Guangdong Southvo Medical Technology Co., Ltd. Qingyuan Guangdong Contract manufacturer 6
Huizhou Jinghao Medical Technology Co., Ltd. Huizhou Guangdong Contract manufacturer 5
Austar Hearing Science & Technology (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 5
Xiamen Retone Hearing Technology Co., Ltd. Xiamen Fujian Contract manufacturer 5
Hangzhou Acosound Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 4
Minami Medical Technology (Guangdong) Co., Ltd. Zhongshan Guangdong Contract manufacturer 4
Sonova Hearing (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 3
Zhongshan Great-Ears Electronic Technology Co., Ltd. Zhongshan Guangdong Contract manufacturer 3
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58

Showing 12 of 45. All 45 manufacturers in China registered for Hearing Aid, Air-Conduction, Prescription

Record

Regulatory record for Audio Service
Listed by WS Audiology USA, Inc., United States
FDA product code ESD
Device type Hearing Aid, Air-Conduction, Prescription
Device class Class 1
Regulation 21 CFR 874.3300
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2019-04-13
Record revised 2023-02-08 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Distribution end date 2020-11-20

Catalogue Numbers

Catalogue numbers for Audio Service
Catalogue number Size Status
S_ITE QUIX 4 G3 -40R (DS) BG Withdrawn
HA DEMO VOLTA XS C BG Withdrawn
HA AS HP 8 G2 GR Withdrawn
HA SYMPATICO RIXX 4 G4 DGT Withdrawn
HA AS TUNE MOOD G4 SB Withdrawn
C_ITE DUMMY ICON Withdrawn
HA AS DUO 12 G4 SLV Withdrawn
HA AS P 8 G3 BG Withdrawn
HA DUO LI-ION 4 G5 SB Withdrawn
HA AS XS 8 G2 CHL Withdrawn
HA AS P 8 G3 GNT Withdrawn
HA RIXX 8 G4 DGT Withdrawn
HA SYMPATICO MOOD 6 G4 DGT Withdrawn
HA AS XS 6 G2 GR- DGT Withdrawn
HA RIXX 16 G5 SLV Withdrawn
HA XS 4 G3 DGT Withdrawn
HA TUNE SUN G4 GNT Withdrawn
HA VOLTA HP T BG Withdrawn
HA XS 4 G4 DGT Withdrawn
BTE AS MOOD 8 G2 GR Withdrawn
HA AS P 12 G2 SLV – DGT Withdrawn
HA SUN 8 G5 GNT Withdrawn
BTE AS MOOD 16 G2 BG Withdrawn
HA MOOD 3 G4 BRN Withdrawn
HA RIXX 8 G4 BRN Withdrawn
HA AS MEZZO 4 DUO H2775 BRN Withdrawn
HA RIXX 12 G4 BG Withdrawn
HA AS MOOD 16 G3 BLK Withdrawn
HA AS DUO 12 G3 BG Withdrawn
HA VOLTA HP C GR Withdrawn
HA DUO 4 G4 BG Withdrawn
DUMMY MOOD G4 SLV Withdrawn
C_ITE SINA 8 G3 Withdrawn
HA AS DUO 16 G4 SLV Withdrawn
HA AS MOOD 8 G2 GNT Withdrawn
HA MOOD 3 G4 SLV Withdrawn
HA TUNE T DUO G4 A SLV Withdrawn
S_ITE QUIX 4 G3 -40L (DS) BG Withdrawn
HA AS AS 1 BG Withdrawn
C_ITE IDA HYPE 16 G4 Withdrawn
HA SUN 16 G4 PRL Withdrawn
HA VOLTA P M GR Withdrawn
HA DUO 12 G5 DGT Withdrawn
S_ITE QUIX M T3MOC L BG Withdrawn
HA SUN 16 G3 BLK Withdrawn
HA SYMPATICO MOOD 4 G4 DGT Withdrawn
HA AS TUNE MOOD G4 SLV Withdrawn
HA AS RIXX 16 G2 SB Withdrawn
HA AS XS 12 G2 CHL Withdrawn
HA AS TUNE T DUO G4 SLV Withdrawn
HA RIXX 8 G4 PRL Withdrawn
HA AS MEZZO 6 DUO H2775 SLV Withdrawn
HA P 8 G5 DBR Withdrawn
HA TUNE DUO G5 PRL Withdrawn
HA TUNE DUO G5 LI-ION GNT Withdrawn
HA VOLTA P T DBR Withdrawn
HA TUNE MOOD G4 A GR Withdrawn
HA AS DUO 4 GR Withdrawn
HA AS P 4 G2 SLV – DGT Withdrawn
HA XS 6 G3 GR- DGT Withdrawn
HA HP 3 G4 GR Withdrawn
HA AS MOOD 12 G4 PRL Withdrawn
S_ITE QUIX 16 G2 – 40 R BG Withdrawn
S_ITE QUIX 6 G4 R TRD Withdrawn
HA AS RIXX 16 G2 GNT Withdrawn
HA AS RIXX 8 G2 SLV Withdrawn
BTE AS MOOD 8 G2 SB Withdrawn
HA AS DUO 3 G4 DGT Withdrawn
HA AS ASTRAL 23 HP GR Withdrawn
HA SUN 12 G5 DGT Withdrawn
HA AS XS 16 G2 GR Withdrawn
HA SUN 12 G4 DGT Withdrawn
HA SUN 12 G4 BRN Withdrawn
HA AS MEZZO 4 XS CHL Withdrawn
HA AS MOOD 12 G4 GNT Withdrawn
HA SYMPATICO DUO 3 G4 DGT Withdrawn
S_ITE QUIX 12 G5 R BLK TRD Withdrawn
HA AS RIVA 2 DUO BG Withdrawn
HA VOLTA XS C GR – DGT Withdrawn
C_ITE DUMMY IDA Withdrawn
HA VOLTA XS C BRN – DGT Withdrawn
HA SUN 12 G4 LI-ION BRN Withdrawn
HA SUN 12 G4 LI-ION GNT Withdrawn
HA AS MOOD 8 G3 BRN Withdrawn
HA AS DUO 8 G2 H2842 SLV Withdrawn
BTE ECO 5 DUO DGT Withdrawn
HA AS MOOD 16 G4 SLV Withdrawn
C_ITE SINA 16 G3 Withdrawn
HA AS P 4 G3 SLV – DGT Withdrawn
HA SUN 12 G3 BLK Withdrawn
HA DUO LI-ION 4 G5 SLV Withdrawn
HA TUNE RIXX G5 SB Withdrawn
HA AS RIVA 2 HP GR Withdrawn
HA AS MEZZO 6 DUO H2775 BG Withdrawn
HA RIXX 6 G3 GNT Withdrawn
HA SYMPATICO RIXX 16 G4 SB Withdrawn
HA AS DUO 16 G4 DGT Withdrawn
HA TUNE SUN G4 PRL Withdrawn
HA AS DUO 6 G3 BRN – DGT Withdrawn
HA AS DUO 4 G3 GR – DGT Withdrawn
C_ITE VEGA 8 G4 Withdrawn
HA SUN 16 G5 SB Withdrawn
HA XS 3 G4 SLV – DGT Withdrawn
C_ITE DUMMY SINA Withdrawn
S_ITE SHELL QUIX G3 BLU Withdrawn
HA AS DUO 6 G3 SLV – DGT Withdrawn
HA SYMPATICO DUO 6 G4 SLV Withdrawn
HA AS DUO 8 G3 BG Withdrawn
HA AS MEZZO 4 P BG Withdrawn
HA DUO 4 G4 SLV Withdrawn
HA AS MOOD 6 G3 BG Withdrawn
HA HP 3 G3 DBR Withdrawn
HA AS DUO 12 G2 H2842 PRL Withdrawn
HA DUO 8 G5 LI-ION PRL Withdrawn
HA AS ASTRAL 12 S BG Withdrawn
HA TUNE DUO G5 LI-ION BG Withdrawn
C_ITE SINA 3 G4 Withdrawn
C_ITE IDA 12 G4 Withdrawn
HA AS DUO 4 G2 DGT Withdrawn
C_ITE VEGA 3 G3 Withdrawn
HA MOOD 6 G4 BG Withdrawn
HA DUO 4 G4 BRN Withdrawn
HA AS MOOD 12 G3 BG Withdrawn
HA TUNE DUO G5 LI-ION SLV Withdrawn
C_ITE IDA 16 G3 Withdrawn
HA RIXX 8 G5 SB Withdrawn
HA AS P 8 G3 DGT Withdrawn
HA RIXX 8 G3 PRL Withdrawn
HA AS RIXX 8 G2 GR Withdrawn
HA AS P 3 G3 GR – DGT Withdrawn
HA SYMPATICO RIXX 16 G4 SLV Withdrawn
HA TUNE T 2.0 RIXX G5 DGT Withdrawn
HA AS XS 16 G2 BG Withdrawn
HA AS DUO 16 G2 H2842 BG Withdrawn
HA HP 6 G4 BG Withdrawn
HA SUN 12 G4 LI-ION PRL Withdrawn
HA TUNE RIXX G5 SLV Withdrawn
HA AS DUO 8 G3 GNT Withdrawn
HA AS NOVA 2 BG Withdrawn
HA SUN 16 G5 NT SLV Withdrawn
HA SUN 16 G4 GR Withdrawn
C_ITE IDA 6 G3 Withdrawn
HA AS TUNE T MOOD G4 SLV Withdrawn
S_ITE QUIX 16 G4 T3MOC R TRD Withdrawn
C_ITE VEGA 12 G3 Withdrawn
HA TUNE SUN G4 SLV Withdrawn
HA AS RIXX 8 G2 SB Withdrawn
BTE AS MOOD 12 G2 CHL Withdrawn
HA AS MOOD 12 G3 GR Withdrawn
HA DUO 8 G5 LI-ION DGT Withdrawn
HA AS P 8 G3 SB Withdrawn
HA AS MEZZO 4 XS BRN Withdrawn
HA SUN 16 G4 LI-ION PRL Withdrawn
HA AS ASTRAL 12 S GR Withdrawn
HA AS MEZZO 4 DUO H2775 SLV Withdrawn
BTE AS MOOD 16 G2 BRN Withdrawn
HA SUN 16 G4 LI-ION SLV Withdrawn
HA RIXX 16 G5 GR Withdrawn
HA XS 6 G3 BG Withdrawn
HA DEMO HP 3 G4 BG Withdrawn
BTE AS MOOD 16 G2 CHL Withdrawn
S_ITE QUIX 4 G3 -40R BG Withdrawn
HA AS NOVA 2 MINI BG Withdrawn
HA P 16 G4 GR Withdrawn
HA AS DUO 12 G4 DGT Withdrawn
HA DUO 12 G5 LI-ION DBR Withdrawn
HA RIXX 16 G4 GNT Withdrawn
S_ITE QUIX 4 G2 – 40 L BG Withdrawn
HA P 12 G5 SLV Withdrawn
HA AS P 6 G2 SLV – DGT Withdrawn
HA AS ASTRAL 12 P BG Withdrawn
HA XS 6 G4 GR – DGT Withdrawn
HA DUO LI-ION 6 G5 DGT Withdrawn
HA RIXX 8 G3 GR Withdrawn
S_ITE QUIX 8 G5 R BLK TRD Withdrawn
HA AS DUO 16 G3 PRL Withdrawn
HA SUN 12 G4 PRL Withdrawn
HA AS P 12 G3 GR Withdrawn
HA P 8 G5 SB Withdrawn
HA SUN 8 G4 GR Withdrawn
C_ITE VEGA HYPE 4 G4 Withdrawn
HA SUN 16 G3 SLV Withdrawn
HA AS MOOD 12 G2 PRL Withdrawn
HA AS RIXX G3 TN BLK Withdrawn
HA RIXX 8 G4 SLV Withdrawn
C_ITE ICON 12 G3 Withdrawn
HA TUNE SUN G4 SB Withdrawn
HA AS P 16 G3 DGT Withdrawn
HA AS MEZZO 6 XS GR Withdrawn
HA AS SUN 6 SLV Withdrawn
HA AS P 16 G2 GR – DGT Withdrawn
HA VOLTA HP M BG Withdrawn
HA AS TUNE DUO G4 SLV Withdrawn
HA AS P 16 G3 SB Withdrawn
HA TUNE MOOD G4 A SLV Withdrawn
HA AS DUO 6 G3 BG Withdrawn
HA SUN 16 G4 LI-ION GR Withdrawn
HA SUN 8 G4 LI-ION GR Withdrawn
HA AS DUO 16 G4 PRL Withdrawn
HA RIXX 6 G4 BG Withdrawn
HA P 12 G5 GNT Withdrawn
HA SUN 16 G4 LI-ION BRN Withdrawn
HA SUN 6 G4 LI-ION GR Withdrawn
HA HP 3 G3 BG Withdrawn
HA RIXX 12 G4 PRL Withdrawn
HA AS DUO 4 G3 SLV – DGT Withdrawn
HA SUN 6 G4 LI-ION SLV Withdrawn
HA TUNE HP G4 DGT Withdrawn
HA XS 3 G4 DGT Withdrawn
HA RIXX 12 G5 GR Withdrawn
HA AS NOVA 2 P GR Withdrawn
C_ITE SINA HYPE 6 G4 Withdrawn
HA HP 4 G4 BG Withdrawn
HA DUO 8 G5 LI-ION SB Withdrawn
BTE AS MOOD 12 G2 BRN Withdrawn
HA AS DUO 12 G4 SB Withdrawn
HA AS ASTRAL 12 S BRN Withdrawn
HA RIXX 12 G5 GNT Withdrawn
HA SUN 16 G4 SLV Withdrawn
C_ITE SINA HYPE 4 G4 Withdrawn
HA AS XS 6 G2 BG Withdrawn
HA AS MOOD 12 G4 SB Withdrawn
HA AS MOOD 8 G3 SLV Withdrawn
HA AUREL 8 DUO G2 SLV Withdrawn
HA AS MOOD 12 G4 GR Withdrawn
HA P 3 G4 GR Withdrawn
HA TUNE T HP G4 GR Withdrawn
HA SUN 16 G3 SB Withdrawn
HA AS P 12 G3 SLV Withdrawn
HA SCALA OTELLO 4 G2 XS DGT Withdrawn
C_ITE VEGA VOLTA C Withdrawn
HA AS P 8 G2 BRN – DGT Withdrawn
HA TUNE DUO G4 A DGT Withdrawn
BTE AS MOOD 8 G2 PRL Withdrawn
HA AS XS 8 G2 SB Withdrawn
HA DUO 6 G4 GR Withdrawn
HA AS XS 16 G2 BRN Withdrawn
HA RIXX 8 G4 GR Withdrawn
S_ITE QUIX 8 G3 -40L BG Withdrawn
HA AS SUN 8 SLV Withdrawn
C_ITE IDA 16 G4 Withdrawn
HA DUO 12 G5 GR Withdrawn
BTE AS MOOD 16 G2 PRL Withdrawn
HA AS DUO 16 G3 SB Withdrawn
HA SUN 16 G3 GR Withdrawn
HA AS MOOD 8 G3 BG Withdrawn
HA AS P 16 G3 GR Withdrawn
HA TUNE T 2.0 DUO G4 A DGT Withdrawn
HA AS NOVA 2 HP TB Withdrawn
HA AS RIXX G3 TN BRN Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Phonak Phonak, Inc. 610
GN ReSound GN Hearing A/S 510
Rexton WS Audiology USA, Inc. 363
GN Hearing GN Hearing A/S 329
Beltone GN Hearing A/S 313
Siemens WS Audiology USA, Inc. 301
Unitron Unitron Hearing 278
Widex Widex A/S 177
Tianle Zhongshan Tianle Hearing Technology Co., Ltd. 146
Audina Audina Hearing Instruments, Inc. 144
Newsound Xiamen New Sound Technology Co., Ltd. 142
Biopor® AB Dreve Otoplastik GmbH 133

Showing 12 of 347. All products under Hearing Aid, Air-Conduction, Prescription

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer