Otoport Pro Advanced Clinical+AABR
Otoport Pro is a handheld instrument for objective hearing screening and clinical assessment. It measures otoacoustic emissions and auditory brainstem responses to sound, including tests…
Otoport Pro is a handheld instrument for objective hearing screening and clinical assessment. It measures otoacoustic emissions and auditory brainstem responses to sound, including tests for patients who cannot give reliable voluntary responses, particularly infants.
An ear probe or earphone delivers sound and records otoacoustic responses; surface electrodes record brainstem responses. The instrument supports DPOAE, TEOAE, and automated ABR testing. Screening results are automatically interpreted and displayed as Pass or Refer.
Listed Item
Handheld, portable, Otoacoustic Emission [OAE] analyser for advanced hearing test applications and Automated Auditory Brainstem Response (AABR) screener. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+TEOAE+AABR Advanced Clinical licence
Clinical Use
Clinical DPOAE and TEOAE analysis is for audiologists or professionals skilled in audiology and can be used across age groups. A trained screener may perform well-baby screening when there are no ear-related medical conditions; other screening requires an audiologist or medical professional.
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 | Otodynamics, Ltd., United Kingdom |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Manufacturer |
| 510(k) | K240430 |
| Record published | 2024-07-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OPRO-ADV-DTA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| GN Otometrics A/S | Natus Medical Denmark ApS | 88 |
| 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 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234095 | 2024-06-21 |
| K240430 | 2024-03-15 |
| K143395 | 2015-02-23 |
| K072033 | 2007-11-13 |
| K983350 | 1998-12-11 |
| K983352 | 1998-12-11 |
| K983351 | 1998-12-11 |
| K962995 | 1997-01-10 |
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.