Audibel
318 catalogue numbers from AUDIBEL DAVINCI I1000 ITE, listed by Starkey Laboratories, Inc., United States, under Masker, Tinnitus. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
318catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (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 |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Starkey Laboratories, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Manufacturer |
| Record published | 2018-08-27 |
| Record revised | 2025-08-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AUDIBEL DAVINCI I1000 ITE | In distribution | |
| START 1200 WRLS CIC | In distribution | |
| A4 IQ GOLD ITE | In distribution | |
| AUDIBEL VIA AI 1000 BTE 13 | In distribution | |
| AUDIBEL DAVINCI I2400 CIC | In distribution | |
| START 8 WRLS MRIC 312 | In distribution | |
| A2 PLATINUM WRLS MRIC 312 | In distribution | |
| Start 1200 BTE 13 | In distribution | |
| AUDIBEL ARC AI 2000 CIC NW | In distribution | |
| START 1000 WRLS ITC | In distribution | |
| AUDIBEL VIA AI 1000 HS R | In distribution | |
| A4 IQ SILVER MRIC 312 | In distribution | |
| START 1000 ITE | In distribution | |
| AUDIBEL DAVINCI 1000 IIC | In distribution | |
| AUDIBEL ARC AI 1200 ITE R | In distribution | |
| AUDIBEL INTRIGUE AI 16 ITC R | In distribution | |
| Audibel Aris AI mRIC R (TIER DEMO) | In distribution | |
| A4 Platinum Wrls BTE 13 | In distribution | |
| A4 CROSBICROS BTE 312 | In distribution | |
| AUDIBEL SIGNATURE SERIES 24 CIC NW | In distribution | |
| START IQ 1000 WRLS BTE 13 PWRPLS | In distribution | |
| (TIER DEMO) AUDIBEL ARC AI BTE 13 | In distribution | |
| A4 SILVER ITC | In distribution | |
| AUDIBEL DAVINCI 1600 HALF SHELL | In distribution | |
| AUDIBEL ARC AI 2000 ITE R | In distribution | |
| START 1000I WRLS RIC 312R | In distribution | |
| START IQ 1200 BTE 13 PWRPLS | In distribution | |
| Audibel Aris AI mRIC R | In distribution | |
| AUDIBEL INTRIGUE AI 24 ITC R | In distribution | |
| AUDIBEL VIA 1600 HS R | In distribution | |
| START IQ 1200I WRLS RIC 312R | In distribution | |
| AUDIBEL VIA 2400 ITE R | In distribution | |
| A4 Gold BTE 13 | In distribution | |
| AUDIBEL DAVINCI 2000 HALF SHELL | In distribution | |
| AUDIBEL VIA AI CROSBICROS RIC 312 | In distribution | |
| A4 IQ SILVER WRLS ITC | In distribution | |
| AUDIBEL ARC AI 1200 POWER PLUS BTE 13 | In distribution | |
| AUDIBEL INTRIGUE AI 20 CIC 312 | In distribution | |
| AUDIBEL VITALITY AI 24 CIC | In distribution | |
| A4I IQ GOLD WRLS RIC 312 | In distribution | |
| (TIER DEMO) AUDIBEL ARC AI MRIC 312 | In distribution | |
| AUDIBEL VIA AI 2400 BTE 13 | In distribution | |
| (DEMO) AUDIBEL ARC AI 2400 BTE R | In distribution | |
| AUDIBEL DAVINCI 1000 CIC | In distribution | |
| AUDIBEL ARC AI 1600 BTE 13 | In distribution | |
| START IQ 1200 BTE 13 | In distribution | |
| AUDIBEL VITALITY AI 24 RIC 312 (DEMO) | In distribution | |
| AUDIBEL VIA AI 2400 ITC R | In distribution | |
| AUDIBEL INTRIGUE AI 12 ITE R | In distribution | |
| AUDIBEL VITALITY AI CROS RIC RT | In distribution | |
| START 1200 WRLS ITC | In distribution | |
| START IQ 1000 CIC | In distribution | |
| START 1000 WRLS RIC 312t | In distribution | |
| AUDIBEL VIA EDGE AI 2400 BTE R | In distribution | |
| START 1200 RIC 312t | In distribution | |
| AUDIBEL ARC AI 2400 BTE 13 | In distribution | |
| AUDIBEL SIGNATURE SERIES 16 CIC R NW | In distribution | |
| (Demo) AUDIBEL VIA BTE 13 | In distribution | |
| A4 IQ SILVER WRLS BTE 13 | In distribution | |
| START IQ 1200 WRLS CIC | In distribution | |
| AUDIBEL MODEL A 2 BTE 13 | In distribution | |
| A4 IQ GOLD WRLS BTE 312 | In distribution | |
| AUDIBEL INTRIGUE AI 24 ITE R | In distribution | |
| A4 IQ PLATINUM WRLS RIC 312 | In distribution | |
| AUDIBEL DAVINCI I2000 HALF SHELL | In distribution | |
| AUDIBEL INTRIGUE AI 20 CIC NW | In distribution | |
| AUDIBEL ARC AI 2400 RIC 312 | In distribution | |
| START 1200 WRLS BTE 312 | In distribution | |
| AUDIBEL INTRIGUE AI MRIC R | In distribution | |
| AUDIBEL VITALITY AI 12 ITC R | In distribution | |
| AUDIBEL INTRIGUE AI 24 MRIC R | In distribution | |
| START IQ 1000 WRLS RIC R | In distribution | |
| AUDIBEL VIA AI 1000 ITC R | In distribution | |
| AUDIBEL DAVINCI I1600 CIC | In distribution | |
| AUDIBEL VIA 1200 MRIC 312 | In distribution | |
| AUDIBEL VIA AI 1200 BTE R | In distribution | |
| AUDIBEL VIA AI 1600 RIC R | In distribution | |
| A4 GOLD MRIC 312 | In distribution | |
| AUDIBEL ARC AI 1000 RIC 312 | In distribution | |
| INVISIBEL SYN IQ SILVER WRLS IIC | In distribution | |
| AUDIBEL VIA AI 2000 BTE 13 | In distribution | |
| AUDIBEL DAVINCI 1600 CIC | In distribution | |
| AUDIBEL DAVINCI 2400 IIC | In distribution | |
| AUDIBEL INTRIGUE AI 24 CIC NW | In distribution | |
| A4 IQ PLATINUM MRIC 312R | In distribution | |
| START IQ 1000 WRLS CIC | In distribution | |
| AUDIBEL VITALITY AI 20 CIC | In distribution | |
| START 1000 WRLS BTE 13 PWRPLS | In distribution | |
| AUDIBEL ARC AI 1000 HS R | In distribution | |
| Audibel Aris AI 16 ITC R | In distribution | |
| A4 SILVER HALF SHELL | In distribution | |
| START 1200I WRLS RIC 312R | In distribution | |
| AUDIBEL VIA 1000 HS R | In distribution | |
| AUDIBEL VIA AI 1000 ITE R | In distribution | |
| A4 IQ SILVER WRLS MRIC 312 | In distribution | |
| AUDIBEL VIA AI CROSBICROS RIC R | In distribution | |
| A4 PLATINUM WRLS ITC | In distribution | |
| AUDIBEL DAVINCI 1200 CIC | In distribution | |
| AUDIBEL ARC AI 1200 RIC R | In distribution | |
| AUDIBEL VITALITY AI 24 ITC R | In distribution | |
| START 1200 WRLS ITE | In distribution | |
| AUDIBEL VIA AI 1000 RIC R | In distribution | |
| START 1000 WRLS RIC 13 | In distribution | |
| AUDIBEL VIA AI 2400 RIC 312 | In distribution | |
| AUDIBEL VIA 2400 BTE 13 | In distribution | |
| AUDIBEL VITALITY AI 12 ITE R | In distribution | |
| AUDIBEL DAVINCI I1600 ITE | In distribution | |
| AUDIBEL VIA 1000A BTE 13 | In distribution | |
| AUDIBEL VIA AI 2400 RIC 312 | In distribution | |
| A4I SILVER WRLS RIC 312R | In distribution | |
| A4 PLATINUM MRIC 312 | In distribution | |
| AUDIBEL SIGNATURE SERIES 16 CIC NW | In distribution | |
| AUDIBEL DAVINCI 2400 HALF SHELL | In distribution | |
| AUDIBEL VIA EDGE AI 2400 RIC R | In distribution | |
| AUDIBEL VITALITY AI 24 MRIC R | In distribution | |
| Audibel Aris AI 20 ITC R | In distribution | |
| START IQ 1000 WRLS HALF SHELL | In distribution | |
| A4 IQ SILVER MRIC 312R | In distribution | |
| AUDIBEL VIA AI BTE R | In distribution | |
| A4 GOLD WRLS MRIC 312 | In distribution | |
| START IQ 1200 WRLS MRIC 312 | In distribution | |
| A4 IQ CROSBICROS RIC 312 | In distribution | |
| (DEMO) AUDIBEL ARC AI 2400 MRIC 312 | In distribution | |
| Audibel A Series AI 16 RIC 312 | In distribution | |
| Audibel Aris AI 24 ITE R | In distribution | |
| AUDIBEL VIA EDGE AI CROSBICROS RIC 312 | In distribution | |
| Audibel A Series AI 16 RIC R | In distribution | |
| START 7 WRLS MRIC 312 | In distribution | |
| AUDIBEL VIA AI 1200 ITC R | In distribution | |
| A4I IQ PLATINUM WRLS RIC 312R | In distribution | |
| AUDIBEL DAVINCI I1000 IIC | In distribution | |
| START IQ 1000 ITC | In distribution | |
| AUDIBEL VITALITY AI 24 RIC 312 | In distribution | |
| AUDIBEL VIA AI 1600 RIC 312 | In distribution | |
| A4 IQ GOLD WRLS MRIC 312 | In distribution | |
| AUDIBEL SIGNATURE SERIES 20 CIC NW | In distribution | |
| START IQ 1000 MRIC 312R | In distribution | |
| AUDIBEL VIA 1200 RIC 312 | In distribution | |
| A4 PLATINUM WRLS ITE | In distribution | |
| AUDIBEL ARC AI 1600 IIC NW | In distribution | |
| START IQ 1000 ITE | In distribution | |
| A4 IQ SILVER CIC | In distribution | |
| AUDIBEL VIA AI 2400 HS R | In distribution | |
| AUDIBEL INTRIGUE AI 16 CIC NW | In distribution | |
| A4 IQ PLATINUM ITC | In distribution | |
| AUDIBEL VIA 2400 BTE 13 | In distribution | |
| INVISIBEL SYNERGY GOLD IIC | In distribution | |
| AUDIBEL VIA RIC R | In distribution | |
| AUDIBEL VIA EDGE AI 2400 BTE 13 | In distribution | |
| AUDIBEL VIA AI 2000 HS R | In distribution | |
| START 1200 ITE | In distribution | |
| AUDIBEL VIA 1600 BTE R | In distribution | |
| AUDIBEL ARC AI 1200 MRIC 312 | In distribution | |
| A4I IQ GOLD WRLS RIC 312R | In distribution | |
| AUDIBEL VIA AI CROSBICROS BTE 13 | In distribution | |
| AUDIBEL ARC AI 2000 MRIC 312 | In distribution | |
| START IQ 1200 WRLS BTE 13 | In distribution | |
| START 1200 WRLS BTE 13 PWRPLS | In distribution | |
| A4 IQ SILVER WRLS MRIC 312R | In distribution | |
| START IQ 1200 MRIC 312 | In distribution | |
| START IQ 1200 BTE 312 | In distribution | |
| INVISIBEL SYN IQ 1000 WRLS IIC | In distribution | |
| AUDIBEL ARC AI 2400 POWER PLUS BTE 13 | In distribution | |
| AUDIBEL VIA 2400 RIC 312 | In distribution | |
| A4 IQ GOLD BTE 13 PWRPLS | In distribution | |
| AUDIBEL DAVINCI 2000 ITC | In distribution | |
| Start 1000 Wrls BTE 13 | In distribution | |
| A4 GOLD CIC | In distribution | |
| AUDIBEL VIA 1600 BTE 13 | In distribution | |
| A4 PLATINUM RIC 312t | In distribution | |
| AUDIBEL ARC AI 1000 RIC R | In distribution | |
| AUDIBEL INTRIGUE AI 24 RIC 312 | In distribution | |
| A4 PLATINUM WRLS RIC 312t | In distribution | |
| INVISIBEL SYNERGY SILVER IIC | In distribution | |
| A4 SILVER WRLS CIC | In distribution | |
| A4 IQ PLATINUM BTE 312 | In distribution | |
| Audibel Aris AI 24 RIC 312 | In distribution | |
| AUDIBEL VIA 2000 RIC 312 | In distribution | |
| AUDIBEL VITALITY AI 20 ITC R | In distribution | |
| AUDIBEL VIA AI 2400 MRIC 312 | In distribution | |
| AUDIBEL VIA EDGE AI 2400 RIC 312 | In distribution | |
| INVISIBEL SYN IQ 1200 WRLS IIC | In distribution | |
| AUDIBEL DAVINCI 2400 CIC | In distribution | |
| START IQ 1000 BTE 312 | In distribution | |
| A4I GOLD WRLS RIC 312 | In distribution | |
| INVISIBEL SYNERGY PLATINUM IIC | In distribution | |
| (DEMO) AUDIBEL ARC AI 2400 RIC R | In distribution | |
| A4 IQ SILVER RIC 312 | In distribution | |
| AUDIBEL VIA 2400 BTE 13 | In distribution | |
| AUDIBEL INTRIGUE AI 12 MRIC R | In distribution | |
| A4 CROSBICROS MRIC 312 | In distribution | |
| AUDIBEL SIGNATURE SERIES 20 CIC R NW | In distribution | |
| A4 PLATINUM WRLS BTE 312 | In distribution | |
| START 1000 WRLS CIC | In distribution | |
| A4 SILVER BTE 312 | In distribution | |
| AUDIBEL VIA 1600 RIC 312 | In distribution | |
| Audibel Aris AI 20 ITE R | In distribution | |
| Audibel Aris AI 24 RIC 312 (DEMO) | In distribution | |
| A4I SILVER WRLS RIC 13 | In distribution | |
| AUDIBEL DAVINCI 1200 HALF SHELL | In distribution | |
| A4 SILVER WRLS ITE | In distribution | |
| A4I GOLD WRLS RIC 312R | In distribution | |
| AUDIBEL VIA 2400 MRIC 312 | In distribution | |
| Audibel Aris AI RIC RT (TIER DEMO) | In distribution | |
| INSPIRE X | In distribution | |
| INVISIBEL SYN IQ GOLD IIC | In distribution | |
| AUDIBEL ARC AI 1200 ITC R | In distribution | |
| AUDIBEL VIA AI 2400 RIC R | In distribution | |
| AUDIBEL ARC AI 1000 ITE R | In distribution | |
| Audibel Aris AI 24 RIC RT (DEMO) | In distribution | |
| A4 IQ CROSBICROS BTE 13 | In distribution | |
| INVISIBEL SYN IQ GOLD WRLS IIC | In distribution | |
| AUDIBEL VIA 2000 BTE 13 | In distribution | |
| Audibel Aris AI Cros RIC 312 | In distribution | |
| AUDIBEL INTRIGUE AI 20 MRIC R | In distribution | |
| AUDIBEL DAVINCI 1200 ITC | In distribution | |
| A2 SILVER WRLS MRIC 312 | In distribution | |
| A4I PLATINUM WRLS RIC 312R | In distribution | |
| A4 IQ PLATINUM ITE | In distribution | |
| AUDIBEL VIA 2400 RIC 312 | In distribution | |
| A4 IQ PLATINUM WRLS ITE | In distribution | |
| A4 PLATINUM WRLS BTE 13 PWRPLS | In distribution | |
| A4 Platinum BTE 13 | In distribution | |
| START 1000 CIC | In distribution | |
| START 1000 BTE 13 PWRPLS | In distribution | |
| AUDIBEL VIA AI 2000 RIC 312 | In distribution | |
| AUDIBEL SIGNATURE SERIES 24 CIC R NW | In distribution | |
| A4 IQ PLATINUM CIC | In distribution | |
| START 1000 CIC | In distribution | |
| A4 IQ SILVER WRLS BTE 312 | In distribution | |
| A4 GOLD ITC | In distribution | |
| AUDIBEL ARC AI 2000 HS R | In distribution | |
| AUDIBEL VITALITY AI 16 ITE R | In distribution | |
| AUDIBEL INTRIGUE AI 16 RIC 312 | In distribution | |
| A4I IQ GOLD WRLS RIC 13 | In distribution | |
| START 1200 MRIC 312 | In distribution | |
| INVISIBEL SYNERGY GOLD WRLS IIC | In distribution | |
| START 1200 CIC | In distribution | |
| AUDIBEL DAVINCI 2000 ITE | In distribution | |
| A4 SILVER MRIC 312 | In distribution | |
| AUDIBEL VIA 1200 BTE 13 | In distribution | |
| Audibel A Series AI 16 RIC 312 | In distribution | |
| AUDIBEL VIA AI 1600 BTE R | In distribution | |
| A4 IQ SILVER ITE | In distribution | |
| AUDIBEL MODEL A 2 RIC 312 | In distribution | |
| AUDIBEL VITALITY AI 20 ITE R | In distribution | |
| A4 IQ GOLD WRLS BTE 13 | In distribution | |
| AUDIBEL ARC AI 1000 POWER PLUS BTE 13 | In distribution | |
| AUDIBEL ARC AI 2400 BTE R | In distribution | |
| A4 IQ PLATINUM MRIC 312 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201370 | 2020-06-19 |
| K122876 | 2012-10-31 |
| K030180 | 2003-09-17 |
| K964216 | 1996-12-06 |
| K963838 | 1996-11-26 |
| K963995 | 1996-11-26 |
| K791790 | 1979-10-26 |
| K791142 | 1979-09-28 |
| K791071 | 1979-07-03 |
| K781798 | 1978-11-03 |
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.