GN Otometrics A/S
1081 AURICAL AUD with HI-PRO (US only) Incl. Bone conductor/Insert Phone and TDH Headset
2manufacturers in China registered for this device type
88catalogue numbers in this listing
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K081234 |
| Record published | 2016-09-19 |
| Record revised | 2025-10-30 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1066, ACP ASTERA 2 | In distribution | |
| SILICONE TUBES, 50 PCS | In distribution | |
| Headset ME70 (12 kHz) matched | In distribution | |
| Headset ME70 (8 kHz) | In distribution | |
| “MADSEN XETA, US Only | In distribution | |
| 1022, EAR TIP KIT, 6MM 50PCS | In distribution | |
| MADSEN Astera 2, US Only | In distribution | |
| MADSEN Capella2, TE | In distribution | |
| “TO/TB monitoring system | In distribution | |
| 1081 AURICAL with HI-PRO | In distribution | |
| AURICAL | In distribution | |
| MADSEN Itera II, US Only | In distribution | |
| Occluded ear simulator | In distribution | |
| Insert Phone Stereo (10 ohm) | In distribution | |
| 1022, EAR TIP KIT,18 MM 50PCS | In distribution | |
| AURICAL | In distribution | |
| AURICAL | In distribution | |
| Sound Booth Installation Kit | In distribution | |
| MADSEN Capella2, DP+TE (combo) | In distribution | |
| Headset ME70 (12 kHz) matched | In distribution | |
| Monitor Headset w/cable | In distribution | |
| MADSEN Astera 2, W/O HDA, US Only | In distribution | |
| MADSEN Capella2, DP | In distribution | |
| 1022, EAR TIP KIT, 8MM 50PCS | In distribution | |
| 711 coupler comp. | In distribution | |
| REM Tube, Blue Handle (50 pcs.) | In distribution | |
| MADSEN Itera II, US Only | In distribution | |
| Stereo Microphone Kit | In distribution | |
| Bone Conductor w/ headband and cable | In distribution | |
| Accessory Kit for sound box installation (US) | In distribution | |
| 1066, CABLES, 5-SPEAKER – RCA | In distribution | |
| “Headset HB-7 (8 kHz) matched | In distribution | |
| 1022, EAR TIP KIT, 7MM 50PCS | In distribution | |
| Monitor Speaker Kit | In distribution | |
| Headset HDA 300 | In distribution | |
| MADSEN Itera II, US Only | In distribution | |
| AURICAL | In distribution | |
| 1004, DIN TO JACK MALE ADAPTER | In distribution | |
| 1081 AURICAL w/o HI-PRO | In distribution | |
| 1066, CABLES, 2-SPEAKER – RCA | In distribution | |
| AURICAL | In distribution | |
| Etymotics 10D OAE Probe | In distribution | |
| Microphone, w. table stand ”jack” | In distribution | |
| Insert Phone Mono (10 ohm) | In distribution | |
| 1078, EARTIP STARTER KIT | In distribution | |
| AURICAL | In distribution | |
| Insert Earphone Tube Tips | In distribution | |
| “TO/TB monitoring system | In distribution | |
| 1022, EAR TIP KIT,14 MM 50PCS | Withdrawn | |
| 1022, EAR TIP KIT, 7MM 50PCS | Withdrawn | |
| Headphone (customer) | Withdrawn | |
| 1022, EAR TIP KIT,18 MM 50PCS | Withdrawn | |
| Probe Cover Tip 4 Pcs. | Withdrawn | |
| Starter Kit | Withdrawn | |
| “Headset Monitoring w/ boom mic | Withdrawn | |
| Patient Responder (Red) | Withdrawn | |
| Eartip 3-6mm Yellow, 100 Pcs. | Withdrawn | |
| Eartip 4mm Red, 100 Pcs. | Withdrawn | |
| Eartip, Earlink 3B, small | Withdrawn | |
| 1022, EAR TIP KIT,12,5MM 50PCS | Withdrawn | |
| Eartip, Earlink 3A, standard | Withdrawn | |
| Test Cavity Seal, White | Withdrawn | |
| Probe Cleaning Tool | Withdrawn | |
| EAR tone, Tube Niples | Withdrawn | |
| Eartip 6mm Green, 100 Pcs. | Withdrawn | |
| Eartip 9mm Blue, 100 Pcs. | Withdrawn | |
| Eartip, Earlink 3C, jumbo | Withdrawn | |
| REM Tube, Blue Handle (50 pcs.) | Withdrawn | |
| Eartip 10mm Green, 100 Pcs. | Withdrawn | |
| 1004, DIN TO JACK FEMALE ADAPT | Withdrawn | |
| PATIENT RES.,M-DIN, GRAY | Withdrawn | |
| Patient Signal Switch (grey) | Withdrawn | |
| Eartip 5mm Blue, 100 Pcs | Withdrawn | |
| 1022, EAR TIP KIT, 8MM 50PCS | Withdrawn | |
| OAE Test Cavity | Withdrawn | |
| Eartip 7mm Yellow, 100 Pcs. | Withdrawn | |
| Eartip 8mm Red, 100 Pcs | Withdrawn | |
| Microphone w/ table stand (jack) | Withdrawn | |
| Eartip 14mm Foam, 50 Pcs. | Withdrawn | |
| TO/TB Sound Tube | Withdrawn | |
| 1022, EAR TIP KIT, 11MM 50PCS | Withdrawn | |
| 1022, EAR TIP KIT, 6MM 50PCS | Withdrawn | |
| 1022, EAR TIP KIT, 9.5MM 50PCS | Withdrawn | |
| Patient Responder (Blue) | Withdrawn | |
| 1022, EAR TIP KIT,16 MM 50PCS | Withdrawn | |
| Headset Monitoring w/ boom mic | Withdrawn | |
| Headset Monitoring | Withdrawn | |
| Patient Responder (Grey) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| Audiometer | Etymotic Research, Inc. | 73 |
| Siemens | WS Audiology USA, Inc. | 57 |
| Bio-logic | Natus Medical Incorporated | 33 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 29 |
| Real-EAR | WS Audiology USA, Inc. | 26 |
| Sanibel Supply A/S | Interacoustics A/S | 18 |
| Natus | Natus Medical Incorporated | 14 |
| Grason-Stadler | Diagnostic Group LLC | 12 |
| Interacoustics | Interacoustics A/S | 12 |
| Oscilla | Inmedico A/S | 12 |
| Single Use Eartip | Etymotic Research, Inc. | 12 |
Showing 12 of 348. All products under Audiometer
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.