| Primary Device ID | 00840388207352 | 
| NIH Device Record Key | 9c72d261-fc82-4f20-87b7-053103024a08 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | AUDIBEL | 
| Version Model Number | Audibel Aris AI RIC RT (TIER DEMO) | 
| Company DUNS | 055461479 | 
| Company Name | Starkey Laboratories, Inc. | 
| Device Count | 1 | 
| DM Exempt | true | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Unsafe | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity | 
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840388207352 [Primary] | 
| KLW | Masker, tinnitus | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-09-04 | 
| Device Publish Date | 2025-08-27 | 
| 00842318168290 | AUDIBEL DAVINCI 1000 IIC | 
| 00842318168283 | AUDIBEL DAVINCI 1200 IIC | 
| 00842318168276 | AUDIBEL DAVINCI 1600 IIC | 
| 00842318168269 | AUDIBEL DAVINCI 2000 IIC | 
| 00842318168252 | AUDIBEL DAVINCI 2400 IIC | 
| 00842318168047 | AUDIBEL DAVINCI I1000 IIC | 
| 00842318168030 | AUDIBEL DAVINCI I1200 IIC | 
| 00842318168023 | AUDIBEL DAVINCI I1600 IIC | 
| 00842318168016 | AUDIBEL DAVINCI I2000 IIC | 
| 00842318168009 | AUDIBEL DAVINCI I2400 IIC | 
| 00842318167347 | AUDIBEL DAVINCI 1000 ITE | 
| 00842318167330 | AUDIBEL DAVINCI 1200 ITE | 
| 00842318167323 | AUDIBEL DAVINCI 1600 ITE | 
| 00842318167316 | AUDIBEL DAVINCI 2000 ITE | 
| 00842318167309 | AUDIBEL DAVINCI 2400 ITE | 
| 00842318167293 | AUDIBEL DAVINCI 1000 HALF SHELL | 
| 00842318167286 | AUDIBEL DAVINCI 1200 HALF SHELL | 
| 00842318167279 | AUDIBEL DAVINCI 1600 HALF SHELL | 
| 00842318167262 | AUDIBEL DAVINCI 2000 HALF SHELL | 
| 00842318167255 | AUDIBEL DAVINCI 2400 HALF SHELL | 
| 00842318167248 | AUDIBEL DAVINCI 1000 ITC | 
| 00842318167231 | AUDIBEL DAVINCI 1200 ITC | 
| 00842318167224 | AUDIBEL DAVINCI 1600 ITC | 
| 00842318167217 | AUDIBEL DAVINCI 2000 ITC | 
| 00842318167200 | AUDIBEL DAVINCI 2400 ITC | 
| 00842318167194 | AUDIBEL DAVINCI 1000 CIC | 
| 00842318167187 | AUDIBEL DAVINCI 1200 CIC | 
| 00842318167170 | AUDIBEL DAVINCI 1600 CIC | 
| 00842318167163 | AUDIBEL DAVINCI 2000 CIC | 
| 00842318167156 | AUDIBEL DAVINCI 2400 CIC | 
| 00842318166340 | AUDIBEL DAVINCI I1000 ITE | 
| 00842318166333 | AUDIBEL DAVINCI I1200 ITE | 
| 00842318166326 | AUDIBEL DAVINCI I1600 ITE | 
| 00842318166319 | AUDIBEL DAVINCI I2000 ITE | 
| 00842318166302 | AUDIBEL DAVINCI I2400 ITE | 
| 00842318166296 | AUDIBEL DAVINCI I1000 HALF SHELL | 
| 00842318166289 | AUDIBEL DAVINCI I1200 HALF SHELL | 
| 00842318166272 | AUDIBEL DAVINCI I1600 HALF SHELL | 
| 00842318166265 | AUDIBEL DAVINCI I2000 HALF SHELL | 
| 00842318166258 | AUDIBEL DAVINCI I2400 HALF SHELL | 
| 00842318166241 | AUDIBEL DAVINCI I1000 ITC | 
| 00842318166234 | AUDIBEL DAVINCI I1200 ITC | 
| 00842318166227 | AUDIBEL DAVINCI I1600 ITC | 
| 00842318166210 | AUDIBEL DAVINCI I2000 ITC | 
| 00842318166203 | AUDIBEL DAVINCI I2400 ITC | 
| 00842318166197 | AUDIBEL DAVINCI I1000 CIC | 
| 00842318166180 | AUDIBEL DAVINCI I1200 CIC | 
| 00842318166173 | AUDIBEL DAVINCI I1600 CIC | 
| 00842318166166 | AUDIBEL DAVINCI I2000 CIC | 
| 00842318166159 | AUDIBEL DAVINCI I2400 CIC | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AUDIBEL  90768794  not registered Live/Pending | Starkey Laboratories, Inc. 2021-06-11 | 
|  AUDIBEL  87872834  5595781 Live/Registered | Starkey Laboratories, Inc. 2018-04-11 | 
|  AUDIBEL  76385936  2672076 Live/Registered | STARKEY LABORATORIES, INC. 2002-03-21 | 
|  AUDIBEL  74181598  1707953 Live/Registered | STARKEY LABORATORIES, INC. 1991-07-02 |