Phonak
Phonak Roger MyLink is a neck-loop receiver in the Roger wireless microphone system. It receives audio from a compatible Roger microphone and sends the signal inductively to a hearing…
Phonak Roger MyLink is a neck-loop receiver in the Roger wireless microphone system. It receives audio from a compatible Roger microphone and sends the signal inductively to a hearing instrument or cochlear implant equipped with a telecoil.
The listed 1.1 (02) version is one example in a broader Phonak receiver family. This version has a short 560 mm loop; other family members may differ in design or use.
Listed Item
Roger MyLink short loop 1.1 (02) (light sterling)
Roger MyLink Connection
Roger MyLink functions as the receiving and inductive-transmission link between a Roger microphone and a telecoil-equipped hearing device. The compatible telecoil receives the loop’s audio signal.
Phonak lists volume control, a status indicator and a rechargeable battery for this version. The short loop is detachable and can be replaced with the standard loop option.
45manufacturers in China registered for this device type
610catalogue numbers in this listing
37510(k) clearances naming this product code
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.
| 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
| Listed by | Phonak, Inc., United States |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 052-3184-D02E5 | In distribution | |
| 052-3189-D02P9 | In distribution | |
| 050-0990-F0 | In distribution | |
| 050-0079-P556 | In distribution | |
| 050-0989-F7 | In distribution | |
| 050-0143-38 | In distribution | |
| 052-3116-D02P46 | In distribution | |
| 050-0990-G5 | In distribution | |
| 052-3183-D02Q5 | In distribution | |
| 052-3116-D02E56 | In distribution | |
| 052-3222-D02L89 | In distribution | |
| 050-0079-01 | In distribution | |
| 050-0446-G2 | In distribution | |
| 052-3235-D02Q49 | In distribution | |
| 052-3116-D02066 | In distribution | |
| 052-3182-D02386 | In distribution | |
| 052-3182-D02346 | In distribution | |
| 052-3182-D02Q1 | In distribution | |
| 063-0422-01 | In distribution | |
| 050-0989-G2 | In distribution | |
| 050-0987-01 | In distribution | |
| 050-0143-P9 | In distribution | |
| 052-3116-D02E9 | In distribution | |
| 050-0450-F8 | In distribution | |
| 052-3183-D02P86 | In distribution | |
| 052-3183-D02036 | In distribution | |
| 052-3116-D02Q6 | In distribution | |
| 052-3183-D02P56 | In distribution | |
| 050-0149-P5 | In distribution | |
| 078-0053 | In distribution | |
| 063-0376-01 | In distribution | |
| 050-0143-P8 | In distribution | |
| 052-3116-D02346 | In distribution | |
| 050-0991-13 | In distribution | |
| 052-3182-D0213 | In distribution | |
| 050-0450-34 | In distribution | |
| 078-0054 | In distribution | |
| 050-0987-G4 | In distribution | |
| 063-0137-01 | In distribution | |
| 052-3182-D02376 | In distribution | |
| 050-0992-B4 | In distribution | |
| 052-3182-D02036 | In distribution | |
| 050-0989-F0 | In distribution | |
| 050-0149-P4 | In distribution | |
| 050-0450-F6 | In distribution | |
| 052-3183-D02Q56 | In distribution | |
| 052-3182-D02P6 | In distribution | |
| 052-3222-D02L09 | In distribution | |
| 052-3183-D02069 | In distribution | |
| 052-3116-D02E5 | In distribution | |
| 052-3116-D02P8 | In distribution | |
| 052-3116-D0206 | In distribution | |
| 050-0079-P156 | In distribution | |
| 052-3116-D02P9 | In distribution | |
| 052-3183-D02386 | In distribution | |
| 052-3183-D02379 | In distribution | |
| 050-0149-P6 | In distribution | |
| 063-0375-01 | In distribution | |
| 052-3183-D02T3 | In distribution | |
| 050-0987-70 | In distribution | |
| 052-3116-D02E66 | In distribution | |
| 063-0084-01 | In distribution | |
| 052-3235-D02Q4 | In distribution | |
| 050-0965-G2 | In distribution | |
| 052-3116-D02Q3 | In distribution | |
| 050-0987-33 | In distribution | |
| 052-3183-D02P79 | In distribution | |
| 052-3182-D02P9 | In distribution | |
| 052-3183-D02Q26 | In distribution | |
| 052-3183-D02Q6 | In distribution | |
| 050-0142-P8 | In distribution | |
| 052-3183-D02P5 | In distribution | |
| 052-3183-D02Q76 | In distribution | |
| 052-3183-D02P36 | In distribution | |
| 052-3116-D02Q5 | In distribution | |
| 050-0994-G1 | In distribution | |
| 052-3183-D02P26 | In distribution | |
| 052-3182-D02049 | In distribution | |
| 052-3183-D0237 | In distribution | |
| 050-0991-50 | In distribution | |
| 050-0991-33 | In distribution | |
| 050-0965-F9 | In distribution | |
| 050-0989-33 | In distribution | |
| 050-0450-B3 | In distribution | |
| 052-3189-D02P4 | In distribution | |
| 050-0149-P7 | In distribution | |
| 052-3189-D0238 | In distribution | |
| 052-3183-D02P19 | In distribution | |
| 052-3116-D02P4 | In distribution | |
| 052-3116-D02P86 | In distribution | |
| 050-0079-P3 | In distribution | |
| 063-0049-01 | In distribution | |
| 052-3183-D02046 | In distribution | |
| 052-3184-D0233 | In distribution | |
| 052-3222-D02L0 | In distribution | |
| 052-3183-D02Q39 | In distribution | |
| 052-3222-D02T29 | In distribution | |
| 052-3182-D02P16 | In distribution | |
| 052-3182-D02P49 | In distribution | |
| 052-3182-D02239 | In distribution | |
| 052-3182-D02P29 | In distribution | |
| 050-0450-06 | In distribution | |
| 050-0987-06 | In distribution | |
| 052-3183-D02Q29 | In distribution | |
| 052-3116-D0213 | In distribution | |
| 052-3183-D02349 | In distribution | |
| 050-0079-0156 | In distribution | |
| 050-0079-37 | In distribution | |
| 052-3183-D02016 | In distribution | |
| 052-3184-D0201 | In distribution | |
| 052-3183-D0238 | In distribution | |
| 050-0450-G1 | In distribution | |
| 050-0965-C0 | In distribution | |
| 050-0991-36 | In distribution | |
| 052-3182-D02P96 | In distribution | |
| 050-0143-13 | In distribution | |
| 052-3116-D02Q26 | In distribution | |
| 050-0990-G3 | In distribution | |
| 050-0992-49 | In distribution | |
| 052-3235-D02Q39 | In distribution | |
| 052-3182-D02356 | In distribution | |
| 078-0041 | In distribution | |
| 050-0992-38 | In distribution | |
| 050-0988-33 | In distribution | |
| 050-0079-P4 | In distribution | |
| 052-3182-D02139 | In distribution | |
| 050-0446-B3 | In distribution | |
| 052-3116-D02016 | In distribution | |
| 078-0042 | In distribution | |
| 052-3183-D02T36 | In distribution | |
| 050-0079-P155 | In distribution | |
| 052-3189-D02P2 | In distribution | |
| 052-3182-D02Q66 | In distribution | |
| 052-3182-D0238 | In distribution | |
| 050-0450-G2 | In distribution | |
| 052-3182-D0237 | In distribution | |
| 052-3189-D0237 | In distribution | |
| 050-0991-35 | In distribution | |
| 063-0011-01 | In distribution | |
| 050-0991-B4 | In distribution | |
| 052-3182-D02Q39 | In distribution | |
| 052-3183-D02139 | In distribution | |
| 052-3235-D02P69 | In distribution | |
| 050-0079-P856 | In distribution | |
| 050-0149-13 | In distribution | |
| 063-0077-01 | In distribution | |
| 052-3222-D02M19 | In distribution | |
| 052-3184-D02E9 | In distribution | |
| 063-0069-01 | In distribution | |
| 052-3223-D03L99 | In distribution | |
| 052-3183-D02P66 | In distribution | |
| 052-3182-D02Q19 | In distribution | |
| 050-0992-35 | In distribution | |
| 052-3224-D02 | In distribution | |
| 052-3116-D02Q56 | In distribution | |
| 052-3182-D02Q6 | In distribution | |
| 052-3183-D02Q1 | In distribution | |
| 052-3219-D02M3 | In distribution | |
| 052-3183-D02P2 | In distribution | |
| 052-3235-D02Q5 | In distribution | |
| 050-0992-B3 | In distribution | |
| 050-0989-B3 | In distribution | |
| 052-3184-D0206 | In distribution | |
| 052-3116-D02E86 | In distribution | |
| 052-3223-D03T18 | In distribution | |
| 050-0446-38 | In distribution | |
| 052-3223-D03M19 | In distribution | |
| 050-0992-04 | In distribution | |
| 052-3116-D02P26 | In distribution | |
| 050-0149-P1 | In distribution | |
| 052-3182-D0201 | In distribution | |
| 050-0446-33 | In distribution | |
| 052-3182-D02P5 | In distribution | |
| 052-3189-D02P1 | In distribution | |
| 052-3184-D02F7 | In distribution | |
| 050-0987-B4 | In distribution | |
| 050-0988-13 | In distribution | |
| 050-0143-P3 | In distribution | |
| 050-0450-38 | In distribution | |
| 052-3183-D02P29 | In distribution | |
| 052-3182-D0203 | In distribution | |
| 052-3116-D02P6 | In distribution | |
| 052-3182-D02Q79 | In distribution | |
| 050-0143-P1 | In distribution | |
| 050-0446-06 | In distribution | |
| 052-3183-D02Q2 | In distribution | |
| 050-0142-P6 | In distribution | |
| 050-0988-G4 | In distribution | |
| 050-0446-F6 | In distribution | |
| 050-0079-P656 | In distribution | |
| 050-0991-38 | In distribution | |
| 052-3182-D02P89 | In distribution | |
| 050-0450-G4 | In distribution | |
| 052-3183-D02376 | In distribution | |
| 063-0156-01 | In distribution | |
| 052-3116-D0235 | In distribution | |
| 052-3182-D02P36 | In distribution | |
| 052-3116-D02T3 | In distribution | |
| 052-3116-D02P56 | In distribution | |
| 050-0993-G1 | In distribution | |
| 052-3183-D02Q16 | In distribution | |
| 050-0991-23 | In distribution | |
| 052-3182-D02389 | In distribution | |
| 052-3235-D02P19 | In distribution | |
| 050-0991-12 | In distribution | |
| 050-0989-13 | In distribution | |
| 052-3222-D02M1 | In distribution | |
| 052-3182-D0206 | In distribution | |
| 052-3183-D02239 | In distribution | |
| 050-0987-38 | In distribution | |
| 052-3116-D02P16 | In distribution | |
| 050-0989-B4 | In distribution | |
| 052-3182-D02Q59 | In distribution | |
| 052-3222-D02T19 | In distribution | |
| 050-0989-E5 | In distribution | |
| 050-0079-38 | In distribution | |
| 052-3183-D02336 | In distribution | |
| 052-3182-D02Q56 | In distribution | |
| 050-0965-G4 | In distribution | |
| 052-3183-D02039 | In distribution | |
| 050-0990-33 | In distribution | |
| 050-0142-Q1 | In distribution | |
| 050-0142-01 | In distribution | |
| 063-0083-01 | In distribution | |
| 050-0965-G5 | In distribution | |
| 052-3182-D02P56 | In distribution | |
| 052-3182-D02506 | In distribution | |
| 052-3182-D02P7 | In distribution | |
| 052-3189-D02P3 | In distribution | |
| 052-3182-D02379 | In distribution | |
| 052-3183-D02236 | In distribution | |
| 052-3183-D0223 | In distribution | |
| 052-3116-D0234 | In distribution | |
| 052-3182-D02P3 | In distribution | |
| 052-3183-D02Q46 | In distribution | |
| 052-3183-D02Q66 | In distribution | |
| 052-3116-D02P3 | In distribution | |
| 052-3184-D02G4 | In distribution | |
| 052-3183-D02P59 | In distribution | |
| 052-3183-D02P49 | In distribution | |
| 052-3116-D02P7 | In distribution | |
| 050-0079-P9 | In distribution | |
| 052-3182-D02P2 | In distribution | |
| 050-0965-F7 | In distribution | |
| 050-0450-F7 | In distribution | |
| 052-3116-D02F36 | In distribution | |
| 050-0079-Q156 | In distribution | |
| 052-3220-D03M3 | In distribution | |
| 050-0988-34 | In distribution | |
| 050-0991-06 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Audio Service | WS Audiology USA, Inc. | 1,148 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130790 | 2013-06-27 |
| K972106 | 1997-08-15 |
| K972105 | 1997-08-01 |
| K972097 | 1997-07-30 |
| K964035 | 1996-12-04 |
| K961653 | 1996-05-29 |
| K961622 | 1996-05-17 |
| K953921 | 1995-09-18 |
| K945439 | 1995-08-23 |
| K950758 | 1995-03-21 |
| K946294 | 1995-01-26 |
| K941734 | 1994-05-13 |
| K935791 | 1994-01-26 |
| K932734 | 1993-07-27 |
| K932735 | 1993-07-27 |
| K932175 | 1993-07-08 |
| K930145 | 1993-02-01 |
| K924913 | 1992-11-04 |
| K924914 | 1992-11-04 |
| K924911 | 1992-11-04 |
| K924912 | 1992-11-03 |
| K923743 | 1992-09-28 |
| K915461 | 1991-12-30 |
| K913502 | 1991-09-06 |
| K913503 | 1991-09-06 |
| K912571 | 1991-06-26 |
| K912570 | 1991-06-26 |
| K911210 | 1991-04-17 |
| K911211 | 1991-04-17 |
| K911209 | 1991-04-15 |
| K910028 | 1991-03-08 |
| K910018 | 1991-02-28 |
| K910012 | 1991-02-28 |
| K900831 | 1990-05-23 |
| K900675 | 1990-05-23 |
| K900830 | 1990-05-23 |
| K900829 | 1990-05-23 |
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.