ADHEAR 38203
GUDID 09008737382032
ADHEAR User Kit, Terra Brown
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Head-worn bone-conduction hearing aid| Primary Device ID | 09008737382032 |
| NIH Device Record Key | 342ab12b-5c4e-4fe0-88e2-652a2c5e83b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADHEAR |
| Version Model Number | 38203 |
| Catalog Number | 38203 |
| Company DUNS | 300764032 |
| Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
Customer Support Contacts
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com | |
| Phone | +1(888)633-3524 |
| implants.us@medel.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737382032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172460
FDA Product Code
| LXB | Hearing Aid, Bone Conduction |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2019-11-08 |
On-Brand Devices [ADHEAR]
| 09008737396091 | ADHEAR Headband, blue, bilateral |
| 09008737396084 | ADHEAR Headband, pink, bilateral |
| 09008737396077 | ADHEAR Headband, beige, bilateral |
| 09008737396060 | ADHEAR Headband, black, bilateral |
| 09008737382032 | ADHEAR User Kit, Terra Brown |
| 09008737382025 | ADHEAR User Kit, Dove Silver |
| 09008737382018 | ADHEAR User Kit, Simply Black |
| 09008737382001 | ADHEAR Professional Kit |
| 09008737381998 | ADHEAR Professional Kit |
| 09008737381981 | ADHEAR User Kit, Terra Brown |
| 09008737381974 | ADHEAR User Kit, Dove Silver |
| 09008737381967 | ADHEAR User Kit, Simply Black |
| 09008737522759 | ADHEAR Configuration Software 1.0 DVD |
| 09008737363635 | ADHEAR Configuration Software 1.0 USB |
| 09008737359454 | ADHEAR User Kit, Terra Brown/beige |
| 09008737359447 | ADHEAR User Kit, Terra Brown/brown |
| 09008737359430 | ADHEAR User Kit, Dove Silver/beige |
| 09008737359423 | ADHEAR User Kit, Dove Silver/brown |
| 09008737359416 | ADHEAR User Kit, Simply Black/beige |
| 09008737359409 | ADHEAR User Kit, Simply Black/brown |
| 09008737359393 | ADHEAR Professional Kit, Test/beige |
| 09008737359386 | ADHEAR Professional Kit, Test/brown |
| 09008737353261 | ADHEAR Headband, blue |
| 09008737353254 | ADHEAR Headband, pink |
| 09008737353247 | ADHEAR Headband, beige |
| 09008737347376 | ADHEAR Professional Kit, Test/beige |
| 09008737347369 | ADHEAR Professional Kit, Test/brown |
| 09008737347352 | ADHEAR User Kit, Terra Brown/beige |
| 09008737347345 | ADHEAR User Kit, Terra Brown/brown |
| 09008737347338 | ADHEAR User Kit, Dove Silver/beige |
| 09008737347321 | ADHEAR User Kit, Dove Silver/brown |
| 09008737347314 | ADHEAR User Kit, Simply Black/beige |
| 09008737347307 | ADHEAR User Kit, Simply Black/brown |
| 09008737346911 | ADHEAR Headband, black |
| 09008737346904 | ADHEAR Adhesive Adapters, brown, 15 pcs. |
| 09008737346898 | ADHEAR Adhesive Adapters, beige, 15 pcs. |
| 09008737346881 | ADHEAR Audio Processor, Model 701, Test Device |
| 09008737346874 | ADHEAR Audio Processor, Model 701, Terra Brown |
| 09008737346867 | ADHEAR Audio Processor, Model 701, Dove Silver |
| 09008737346850 | ADHEAR Audio Processor, Model 701, Simply Black |
| 09008737404338 | ADHEAR 701, Test Device, lock |
| 09008737404321 | ADHEAR 701, Terra Brown, lock |
| 09008737404314 | ADHEAR 701, Dove Silver, lock |
| 09008737404307 | ADHEAR 701, Simply Black, lock |
| 09008737382087 | ADHEAR Configuration Software 1.0 Download |
Trademark Results [ADHEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADHEAR 90392375 not registered Live/Pending |
MED-EL Elektromedizinische Geräte Ges.m.b.H. 2020-12-18 |
 ADHEAR 87325196 not registered Live/Pending |
MED-EL Elektromedizinische Geräte Ges.m.b.H. 2017-02-06 |
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