Verifit Skull Simulator
- Primary DI
- B161VA3003
- Brand
- Verifit Skull Simulator
- Company
- Etymonic Design Incorporated
- Model
- VA-300
- Device description
- An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system. The VA-300 Verifit Skull Simulator is a measurement coupler operating in place of a standard acoustic coupler to facilitate measurement of the vibrational output produced by a bone conduction hearing aid. The device is intended as a direct substitute for the acoustic measurement coupler and uses the identical micro-power electrical interface.
- Published
- 2019-05-02
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | Ear, Nose, Throat | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B161VA3003 | Package | HIBCC | 1 | In Commercial Distribution |
| B161VA3000 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bone vibrator mechanical coupler | A device designed to present a specific mechanical impedance to a bone vibrator, applied with a specific static force and equipped with a mechano-electric transducer, to enable an alternating force level at the point of contact between vibrator and mechanical coupler to be determined. Also known as an artificial mastoid, it provides a mechanical load to a bone vibrator that approximates that of the average human mastoid process. The standard (IEC 60318-6) specifies such a device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Handling Environment Atmospheric Pressure | 81 KiloPascal | 106 KiloPascal |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 244780581
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B161VA3000 | Verifit Skull Simulator | VA-300 | 2019-05-02 | |
| B161AXIOM0 | Audioscan | Axiom | 2016-09-23 | |
| B161RM500SL0 | Audioscan | RM500SL | 2016-09-23 | |
| B161RE3670 | Audioscan Probe Tube | RE367 | RE367-40 | 2020-01-15 |
| B161VERIFITVF20 | Audioscan | Verifit VF-2 | 2016-09-23 | |
| B161AXIOM3 | Audioscan | Axiom | 2016-09-23 | |
| B161RM500SL3 | Audioscan | RM500SL | 2016-09-23 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05711781004297 | Measure by Otometrics - HIT | Auditdata A/S | ETW | 2025-11-14 |
| 05711781004372 | Measure by Otometrics - HIT | Auditdata A/S | ETW | 2025-11-14 |
| 05711781004006 | Unity 3 | Auditdata A/S | ETW | 2024-10-21 |
| 05711117244335 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2024-10-07 |
| 05711117228458 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2024-10-07 |
| 00810044583182 | MedRx | MEDRX, INC. | ETW | 2024-05-07 |
| EADF03410600217207189 | audifon | audifon GmbH & Co. KG | ETW | 2023-03-31 |
| 05711117121742 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-12-29 |
| 05711117094206 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-12-29 |
| 05711117226478 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-12-29 |
| 05711117227550 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| 05711117227574 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| 05711117227581 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| 05711117228557 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| 05711117228564 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| 05711117228571 | Sanibel Supply A/S | Interacoustics A/S | ETW | 2022-11-29 |
| EADF034106002172068681 | audifon | audifon GmbH & Co. KG | ETW | 2022-10-21 |
| 05713315009037 | Natus | Natus Medical Denmark ApS | ETW | 2021-04-12 |
| 05713315009044 | Natus | Natus Medical Denmark ApS | ETW | 2021-04-12 |
| 05713315009051 | Natus | Natus Medical Denmark ApS | ETW | 2021-04-12 |
| 05713315008689 | Natus | Natus Medical Denmark ApS | ETW | 2021-01-04 |
| B161RE3670 | Audioscan Probe Tube | Etymonic Design Incorporated | ETW | 2020-01-15 |
| 05711117198218 | Interacoustics | Interacoustics A/S | ETW | 2019-11-26 |
| B161VA3000 | Verifit Skull Simulator | Etymonic Design Incorporated | ETW | 2019-05-02 |
| 05713315005848 | GN Otometrics A/S | Natus Medical Denmark ApS | ETW | 2019-04-24 |
| 05713315008184 | GN Otometrics A/S | Natus Medical Denmark ApS | ETW | 2019-03-18 |
| 05713315005701 | GN Otometrics A/S | Natus Medical Denmark ApS | ETW | 2018-11-06 |
| 05713315003301 | GN Otometrics A/S | Natus Medical Denmark ApS | ETW | 2018-07-31 |
| 08054187380730 | DRUM | INVENTIS SRL | ETW | 2017-08-24 |
| 08054187380617 | TRUMPET | INVENTIS SRL | ETW | 2016-11-23 |